The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

Phase 3

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Placebo
Drug: Laquinimod

Registration Number: NCT01707992

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary: This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2199

Inclusion Criteria

Participants must have a confirmed and documented multiple sclerosis (MS) diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
Participants must be ambulatory with Kurtzke's expanded disability status scale (EDSS) score of 0 to 5.5 in both screening and randomization visits.
Participants must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)/oral] or adrenocorticotrophic hormone, 60 days prior to randomization.
Participants must have experienced at least one documented relapse in the 12 months prior to randomization.
Participants must have disease duration of not more than 15 years.
Women of child-bearing potential (for example, women who are not postmenopausal or surgically sterilized) must practice an acceptable method of birth control for 30 days before taking the study drug and two acceptable methods of birth control during the duration of the study and until 30 days after the last dose of study medication.
- Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria

Participants with progressive forms of MS.
Participants with neuromyelitis optica.
Use of experimental or investigational drugs and/or participation in drug clinical studies within the 6 months prior to randomization.
Use of immunosuppressive agents or cytotoxic agents, including cyclophosphamide, within 6 months prior to randomization.
Use of either of the following within 2 years prior to randomization visit: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.
Use of teriflunomide (Aubagio®) within 2 years prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to randomization.
Previous treatment with glatiramer acetate (Copaxone®) Interferon β (either 1a or 1b), fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®) or intravenous immunoglobulins within 2 months prior to randomization.
Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to randomization.
Previous use of mitoxantrone (Novantrone®), cladribine, or alemtuzumab (Lemtrada®).
Previous use of laquinimod.
Previous total body irradiation or total lymphoid irradiation.
Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
Use of moderate/strong inhibitors of cytochrome P450 (CYP) 3A4 within 2 weeks prior to randomization.
Use of inducers of CYP3A4 within 2 weeks prior to randomization visit.
Pregnancy or breastfeeding.
A known history of sensitivity to gadolinium (Gd).
Inability to successfully undergo magnetic resonance imaging (MRI) scanning.
Participants who underwent endovascular treatment for chronic cerebrospinal venous insufficiency within 3 months prior to randomization.
- Additional criteria apply, please contact the investigator for more information.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-Controlled Phase: Placebo	Placebo	Participants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams \[mg\]) once daily orally for up to 24 months.
Placebo-Controlled Phase: Laquinimod 0.6 mg	Laquinimod	Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.
Placebo-Controlled Phase: Laquinimod 0.6 mg	Placebo	Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.
Placebo-Controlled Phase: Laquinimod 1.2 mg	Laquinimod	Participants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.
Active Treatment Phase: Laquinimod 0.6 mg	Laquinimod	Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.
Active Treatment Phase: Laquinimod 0.6 mg	Placebo	Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.
Active Treatment Phase: Laquinimod 1.2 mg	Laquinimod	Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.

Primary Outcome Measures

Name	Time	Method
Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)	Baseline to Month 24	Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.

Secondary Outcome Measures

Name	Time	Method
Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15	Baseline, Month 15	Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.
Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)	Baseline to Month 24	Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).
Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)	Baseline to Month 24	Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.
Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)	Baseline to Month 24	Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.

Trial Locations

Locations (284): Teva Investigational Site 10315
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Sunrise, Florida, United States
Teva Investigational Site 10342
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Tucson, Arizona, United States
Teva Investigational Site 10341
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Saint Petersburg, Florida, United States
Teva Investigational Site 10316
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Coral Gables, Florida, United States
Teva Investigational Site 10343
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Northbrook, Illinois, United States
Teva Investigational Site 10332
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Fort Collins, Colorado, United States
Teva Investigational Site 10346
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Advance, North Carolina, United States
Teva Investigational Site 10311
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Roanoke, Virginia, United States
Teva Investigational Site 10340
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Hershey, Pennsylvania, United States
Teva Investigational Site 10313
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Cordova, Tennessee, United States
Teva Investigational Site 68008
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Minsk, Belarus
Teva Investigational Site 10345
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Evanston, Illinois, United States
Teva Investigational Site 68010
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Gomel, Belarus
Teva Investigational Site 10330
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Newport News, Virginia, United States
Teva Investigational Site 32189
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Erfurt, Germany
Teva Investigational Site 32203
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Giessen, Germany
Teva Investigational Site 32183
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Koln, Germany
Teva Investigational Site 32184
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Erbach, Germany
Teva Investigational Site 32175
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Ibbenburen, Germany
Teva Investigational Site 32181
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Hamburg, Germany
Teva Investigational Site 32173
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Ulm, Germany
Teva Investigational Site 32202
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Goettigen, Germany
Teva Investigational Site 32196
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Halle (Saale), Germany
Teva Investigational Site 32182
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Hannover, Germany
Teva Investigational Site 32177
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Bochum, Germany
Teva Investigational Site 32201
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Jena, Germany
Teva Investigational Site 32179
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Hamburg, Germany
Teva Investigational Site 32193
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Dresden, Germany
Teva Investigational Site 32185
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Magdeburg, Germany
Teva Investigational Site 32194
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Teupitz, Germany
Teva Investigational Site 30030
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Cefalu, Italy
Teva Investigational Site 80023
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Haifa, Israel
Teva Investigational Site 30027
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Palermo, Italy
Teva Investigational Site 80021
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Tel Aviv, Israel
Teva Investigational Site 87003
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Seoul, Korea, Republic of
Teva Investigational Site 87002
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Seoul, Korea, Republic of
Teva Investigational Site 80024
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Haifa, Israel
Teva Investigational Site 80020
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Ramat Gan, Israel
Teva Investigational Site 30034
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Napoli, Italy
Teva Investigational Site 87001
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Goyang-si, Korea, Republic of
Teva Investigational Site 31032
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Madrid, Spain
Teva Investigational Site 31039
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Oviedo, Spain
Teva Investigational Site 31031
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Getafe, Spain
Teva Investigational Site 34016
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Salford, United Kingdom
Teva Investigational Site 50137
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St. Petersburg, Russian Federation
Teva Investigational Site 31036
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L'Hospitalet de Llobregat, Spain
Teva Investigational Site 58081
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Kyiv, Ukraine
Teva Investigational Site 34017
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Sheffield, United Kingdom
Teva Investigational Site 58075
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Zaporizhzhya, Ukraine
Teva Investigational Site 34011
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Liverpool, United Kingdom
Teva Investigational Site 34013
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Stoke-on-Trent, United Kingdom
Teva Investigational Site 10350
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Chicago, Illinois, United States
Teva Investigational Site 10317
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Columbus, Ohio, United States
Teva Investigational Site 10331
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Philadelphia, Pennsylvania, United States
Teva Investigational Site 10335
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Seattle, Washington, United States
Teva Investigational Site 10348
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Lenexa, Kansas, United States
Teva Investigational Site 10318
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Nashville, Tennessee, United States
Teva Investigational Site 10319
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Salt Lake City, Utah, United States
Teva Investigational Site 30032
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Chieti, Italy
Teva Investigational Site 30040
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Verona, Italy
Teva Investigational Site 30028
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Rome, Italy
Teva Investigational Site 30026
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Rome, Italy
Teva Investigational Site 33014
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Linz, Austria
Teva Investigational Site 59060
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Pleven, Bulgaria
Teva Investigational Site 59057
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Sofia, Bulgaria
Teva Investigational Site 59063
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Sofia, Bulgaria
Teva Investigational Site 68009
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Minsk, Belarus
Teva Investigational Site 68011
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Vitebsk, Belarus
Teva Investigational Site 69008
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Mostar, Bosnia and Herzegovina
Teva Investigational Site 59062
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Plovdiv, Bulgaria
Teva Investigational Site 59052
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Sofia, Bulgaria
Teva Investigational Site 59038
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Sofia, Bulgaria
Teva Investigational Site 59059
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Sofia, Bulgaria
Teva Investigational Site 63024
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Athens, Greece
Teva Investigational Site 70005
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Chisinau, Moldova, Republic of
Teva Investigational Site 66002
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Podgorica, Montenegro
Teva Investigational Site 53066
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Bialystok, Poland
Teva Investigational Site 33013
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Innsbruck, Austria
Teva Investigational Site 33015
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Wien, Austria
Teva Investigational Site 65011
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Skopje, North Macedonia
Teva Investigational Site 68013
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Grodno, Belarus
Teva Investigational Site 68012
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Minsk, Belarus
Teva Investigational Site 59055
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Shumen, Bulgaria
Teva Investigational Site 53069
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Gdansk, Poland
Teva Investigational Site 37024
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Sijsele, Belgium
Teva Investigational Site 59039
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Pleven, Bulgaria
Teva Investigational Site 59061
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Ruse, Bulgaria
Teva Investigational Site 59043
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Sofia, Bulgaria
Teva Investigational Site 59041
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Sofia, Bulgaria
Teva Investigational Site 63027
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Athens, Greece
Teva Investigational Site 63026
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Heraklion, Greece
Teva Investigational Site 51044
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Kaposvar, Hungary
Teva Investigational Site 65010
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Skopje, North Macedonia
Teva Investigational Site 53081
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Katowice, Poland
Teva Investigational Site 53073
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Katowice, Poland
Teva Investigational Site 53070
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Katowice, Poland
Teva Investigational Site 53079
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Olsztyn, Poland
Teva Investigational Site 53068
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Plewiska, Poland
Teva Investigational Site 59058
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Sofia, Bulgaria
Teva Investigational Site 59042
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Sofia, Bulgaria
Teva Investigational Site 59054
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Sofia, Bulgaria
Teva Investigational Site 59051
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Veliko Tarnovo, Bulgaria
Teva Investigational Site 63030
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Larisa, Greece
Teva Investigational Site 53071
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Bialystok, Poland
Teva Investigational Site 52049
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Hunedoara, Romania
Teva Investigational Site 50148
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Kemerovo, Russian Federation
Teva Investigational Site 50128
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Nizhny Novgorod, Russian Federation
Teva Investigational Site 59046
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Varna, Bulgaria
Teva Investigational Site 55005
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Parnu, Estonia
Teva Investigational Site 56006
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Riga, Latvia
Teva Investigational Site 56005
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Riga, Latvia
Teva Investigational Site 70008
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Chisinau, Moldova, Republic of
Teva Investigational Site 53067
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Gdansk, Poland
Teva Investigational Site 53078
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Grodzisk Mazowiecki, Poland
Teva Investigational Site 52041
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Bucharest, Romania
Teva Investigational Site 52047
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Piatra-Neamt, Romania
Teva Investigational Site 52046
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Sibiu, Romania
Teva Investigational Site 50131
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Nizhny Novgorod, Russian Federation
Teva Investigational Site 50139
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Tyumen, Russian Federation
Teva Investigational Site 61019
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Sombor, Serbia
Teva Investigational Site 58077
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Dnipropetrovsk, Ukraine
Teva Investigational Site 58078
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Kyiv, Ukraine
Teva Investigational Site 58115
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Lviv, Ukraine
Teva Investigational Site 50147
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Moscow, Russian Federation
Teva Investigational Site 50146
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Moscow, Russian Federation
Teva Investigational Site 53080
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Katowice, Poland
Teva Investigational Site 53074
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Katowice, Poland
Teva Investigational Site 53065
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Konstancin-Jeziorna, Poland
Teva Investigational Site 53072
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Koscierzyna, Poland
Teva Investigational Site 52048
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Craiova, Romania
Teva Investigational Site 52043
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Timisoara, Romania
Teva Investigational Site 50129
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Chelyabinsk, Russian Federation
Teva Investigational Site 50144
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Krasnodar, Russian Federation
Teva Investigational Site 50141
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Nizhny Novgorod, Russian Federation
Teva Investigational Site 50136
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Smolensk, Russian Federation
Teva Investigational Site 61018
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Cacak, Serbia
Teva Investigational Site 61015
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Kragujevac, Serbia
Teva Investigational Site 62013
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Trnava, Slovakia
Teva Investigational Site 58076
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Ivano-Frankivsk, Ukraine
Teva Investigational Site 50133
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Moscow, Russian Federation
Teva Investigational Site 58084
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Kharkiv, Ukraine
Teva Investigational Site 53076
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Szczecin, Poland
Teva Investigational Site 52045
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Balotesti, Romania
Teva Investigational Site 52050
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Bucuresti, Romania
Teva Investigational Site 52034
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Bucuresti, Romania
Teva Investigational Site 52040
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Cluj-Napoca, Romania
Teva Investigational Site 52035
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Targu Mures, Romania
Teva Investigational Site 50127
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Perm, Russian Federation
Teva Investigational Site 50149
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Rostov-on-Don, Russian Federation
Teva Investigational Site 50134
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Ufa, Russian Federation
Teva Investigational Site 61025
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Belgrade, Serbia
Teva Investigational Site 50124
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Moscow, Russian Federation
Teva Investigational Site 50208
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Kazan, Russian Federation
Teva Investigational Site 50138
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Samara, Russian Federation
Teva Investigational Site 50125
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Tomsk, Russian Federation
Teva Investigational Site 50142
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Yaroslavl, Russian Federation
Teva Investigational Site 61027
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Belgrade, Serbia
Teva Investigational Site 61024
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Belgrade, Serbia
Teva Investigational Site 61016
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Subotica, Serbia
Teva Investigational Site 61017
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Uzice, Serbia
Teva Investigational Site 58073
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Kyiv, Ukraine
Teva Investigational Site 61014
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Nis, Serbia
Teva Investigational Site 61022
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Valjevo, Serbia
Teva Investigational Site 58087
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Chernihiv, Ukraine
Teva Investigational Site 61021
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Zrenjanin, Serbia
Teva Investigational Site 62012
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Hlohovec, Slovakia
Teva Investigational Site 58072
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Vinnytsya, Ukraine
Teva Investigational Site 58082
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Poltava, Ukraine
Teva Investigational Site 58080
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Simferopol, Ukraine
Teva Investigational Site 34010
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Liverpool, United Kingdom
Teva Investigational Site 31034
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Madrid, Spain
Teva Investigational Site 31033
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Navarro, Spain
Teva Investigational Site 10329
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Cullman, Alabama, United States
Teva Investigational Site 59049
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Stara Zagora, Bulgaria
Teva Investigational Site 10349
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Sun City, Arizona, United States
Teva Investigational Site 10310
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Fresno, California, United States
Teva Investigational Site 10334
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Centennial, Colorado, United States
Teva Investigational Site 10308
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Sarasota, Florida, United States
Teva Investigational Site 10339
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Fort Wayne, Indiana, United States
Teva Investigational Site 10338
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Boston, Massachusetts, United States
Teva Investigational Site 10309
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Bellevue, Ohio, United States
Teva Investigational Site 10325
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Dayton, Ohio, United States
Teva Investigational Site 10324
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Franklin, Tennessee, United States
Teva Investigational Site 33016
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Wien, Austria
Teva Investigational Site 37023
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Charleroi, Belgium
Teva Investigational Site 69006
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Sarajevo, Bosnia and Herzegovina
Teva Investigational Site 69009
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Tuzla, Bosnia and Herzegovina
Teva Investigational Site 59040
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Pleven, Bulgaria
Teva Investigational Site 59048
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Sofia, Bulgaria
Teva Investigational Site 59044
🇧🇬
Sofia, Bulgaria
Teva Investigational Site 59050
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Sofia, Bulgaria
Teva Investigational Site 59045
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Sofia, Bulgaria
Teva Investigational Site 59053
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Veliko Tarnovo, Bulgaria
Teva Investigational Site 11014
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Burnaby, British Columbia, Canada
Teva Investigational Site 11016
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Saskatoon, Canada
Teva Investigational Site 11013
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Edmonton, Alberta, Canada
Teva Investigational Site 60010
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Osijek, Croatia
Teva Investigational Site 60011
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Varazdin, Croatia
Teva Investigational Site 11015
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Ottawa, Canada
Teva Investigational Site 54042
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Brno, Czechia
Teva Investigational Site 54043
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Havirov, Czechia
Teva Investigational Site 54047
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Hradec Kralove 3, Czechia
Teva Investigational Site 54045
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Ostrava, Czechia
Teva Investigational Site 54046
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Jihlava, Czechia
Teva Investigational Site 54044
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Olomouc, Czechia
Teva Investigational Site 54049
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Praha 10, Czechia
Teva Investigational Site 54041
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Praha, Czechia
Teva Investigational Site 54048
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Teplice, Czechia
Teva Investigational Site 55008
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Tallinn, Estonia
Teva Investigational Site 55006
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Tallinn, Estonia
Teva Investigational Site 55007
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Tartu, Estonia
Teva Investigational Site 35075
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Clermont-Ferrand Cedex 1, France
Teva Investigational Site 35077
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Dijon, France
Teva Investigational Site 35073
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Lille, France
Teva Investigational Site 35076
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Lyon cedex 04, France
Teva Investigational Site 81018
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Tbilisi, Georgia
Teva Investigational Site 35079
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Nimes, France
Teva Investigational Site 81015
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Tbilisi, Georgia
Teva Investigational Site 81014
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Tbilisi, Georgia
Teva Investigational Site 81019
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Tbilisi, Georgia
Teva Investigational Site 81016
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Tbilisi, Georgia
Teva Investigational Site 81017
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Tbilisi, Georgia
Teva Investigational Site 32199
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Bad Mergentheim, Germany
Teva Investigational Site 32195
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Berg, Germany
Teva Investigational Site 32200
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Berlin, Germany
Teva Investigational Site 32176
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Berlin, Germany
Teva Investigational Site 32186
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Berlin, Germany
Teva Investigational Site 32174
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Berlin, Germany
Teva Investigational Site 32198
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Berlin, Germany
Teva Investigational Site 32190
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Leipzig, Germany
Teva Investigational Site 32188
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Westerstede, Germany
Teva Investigational Site 32191
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Rostock, Germany
Teva Investigational Site 32197
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Wermsdorf, Germany
Teva Investigational Site 63029
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Chaidari, Greece
Teva Investigational Site 51046
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Budapest, Hungary
Teva Investigational Site 63028
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Thessaloniki, Greece
Teva Investigational Site 63025
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Thessaloniki, Greece
Teva Investigational Site 51045
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Eger, Hungary
Teva Investigational Site 51043
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Debrecen, Hungary
Teva Investigational Site 30023
🇮🇹
Milano, Italy
Teva Investigational Site 30031
🇮🇹
Castelfiorentino, Italy
Teva Investigational Site 30024
🇮🇹
Firenze, Italy
Teva Investigational Site 30037
🇮🇹
Bologna, Italy
Teva Investigational Site 30029
🇮🇹
Gallarate, Italy
Teva Investigational Site 30039
🇮🇹
Milano, Italy
Teva Investigational Site 30025
🇮🇹
Rome, Italy
Teva Investigational Site 30035
🇮🇹
Rome, Italy
Teva Investigational Site 70006
🇲🇩
Chisinau, Moldova, Republic of
Teva Investigational Site 65012
🇲🇰
Skopje, North Macedonia
Teva Investigational Site 53085
🇵🇱
Bydgoszcz, Poland
Teva Investigational Site 53084
🇵🇱
Czestochowa, Poland
Teva Investigational Site 53083
🇵🇱
Gdansk, Poland
Teva Investigational Site 53063
🇵🇱
Lodz, Poland
Teva Investigational Site 53064
🇵🇱
Konskie, Poland
Teva Investigational Site 52037
🇷🇴
Bucuresti, Romania
Teva Investigational Site 52038
🇷🇴
Constanta, Romania
Teva Investigational Site 52044
🇷🇴
Constanta, Romania
Teva Investigational Site 52039
🇷🇴
Oradea, Romania
Teva Investigational Site 52036
🇷🇴
Cluj-Napoca, Romania
Teva Investigational Site 52042
🇷🇴
Iasi, Romania
Teva Investigational Site 50130
🇷🇺
Barnaul, Russian Federation
Teva Investigational Site 50140
🇷🇺
Saint Petersburg, Russian Federation
Teva Investigational Site 50143
🇷🇺
Rostov-on-Don, Russian Federation
Teva Investigational Site 50126
🇷🇺
Saint Petersburg, Russian Federation
Teva Investigational Site 50135
🇷🇺
Saratov, Russian Federation
Teva Investigational Site 50132
🇷🇺
Volgograd, Russian Federation
Teva Investigational Site 58085
🇺🇦
Odessa, Ukraine
Teva Investigational Site 61026
🇷🇸
Vrbas, Serbia
Teva Investigational Site 31030
🇪🇸
Barcelona, Spain
Teva Investigational Site 31035
🇪🇸
Barcelona, Spain
Teva Investigational Site 58116
🇺🇦
Kharkiv, Ukraine
Teva Investigational Site 31037
🇪🇸
Salt, Spain
Teva Investigational Site 58083
🇺🇦
Chernivtsi, Ukraine
Teva Investigational Site 58088
🇺🇦
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58089
🇺🇦
Kiev, Ukraine
Teva Investigational Site 58086
🇺🇦
Lviv, Ukraine
Teva Investigational Site 58074
🇺🇦
Odesa, Ukraine
Teva Investigational Site 58079
🇺🇦
Zaporizhzhya, Ukraine
Teva Investigational Site 34015
🇬🇧
Glasgow, United Kingdom
Teva Investigational Site 34019
🇬🇧
London, United Kingdom
Teva Investigational Site 60009
🇭🇷
Zagreb, Croatia
Teva Investigational Site 10307
🇺🇸
Aurora, Colorado, United States
Teva Investigational Site 10347
🇺🇸
Winston-Salem, North Carolina, United States
Teva Investigational Site 10323
🇺🇸
Tampa, Florida, United States