Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
- Conditions
- Relapsing Multiple Sclerosis
- Interventions
- Registration Number
- NCT02047734
- Lead Sponsor
- Celgene
- Brief Summary
This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.
The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).
- Detailed Description
This clinical trial (RPC01-201; RADIANCE) consisted of 2 parts, each reported separately on ClinicalTrials.gov: Part A (NCT01628393) and Part B (this record).
Part A was a phase 2 study in which two doses of ozanimod were administered daily for 24 weeks with an efficacy and safety comparison to a placebo control and is reported separately as ClinicalTrials.gov record NCT01628393.
Part B, reported herein, was a phase 3 study in which two doses of ozanimod were administered daily for a 24 month period compared to an active control, interferon β-1a. Participants were allowed to enroll in the open-label extension study RPC01-3001 (NCT02576717) or complete the study with a safety follow-up visit 28 days after their last dose of study treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1320
- Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
- Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline
- Primary progressive multiple sclerosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ozanimod 0.5 mg Interferon beta-1a placebo Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months. Ozanimod1 mg Interferon beta-1a placebo Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months. Interferon β-1a Ozanimod placebo interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months. Ozanimod 0.5 mg Ozanimod Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months. Ozanimod1 mg Ozanimod Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months. Interferon β-1a Interferon beta-1a interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.
- Primary Outcome Measures
Name Time Method Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 At the end of month 24 A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for \> 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores.
Relapse rate was calculated as the total number of confirmed relapses divided by the total number of days in the study \* 365.25.
ARR was based on a Poisson regression model, adjusted for region (Eastern Europe vs Rest of the World), age, and the Baseline number of gadolinium-enhancing lesions, and included the natural log transformation of time on study as an offset term.
- Secondary Outcome Measures
Name Time Method Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months 24 month treatment period; MRI scans were performed at Months 12 and 24 The adjusted mean number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan was based on the cumulative number of new or enlarging T2 lesions since Baseline over 24 months. MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
The adjusted mean per scan over 24 months was based based on a negative binomial regression model using observed data, adjusted for region (Eastern Europe vs. Rest of the World), age at Baseline, and Baseline number of GdE lesions. The natural log transformation of the number of available MRI scans over 24 months is used as an offset term.Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24 Month 24 MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
The number of gadolinium-enhancing (GdE) lesions at 24 months was analyzed based on observed data using a negative binomial regression model adjusted for region (Eastern Europe vs Rest of World), Baseline age, and Baseline number of GdE lesions, with natural log transformation of number of available MRI scans over 24 months as an offset term (1 scan for per participant).Time to Onset of Disability Progression Confirmed After 3 Months From first dose to the end of the 24-month treatment period EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present.
The EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments.
Disability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.Time to Onset of Disability Progression Confirmed After 6 Months From first dose to the end of the 24-month treatment period EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present.
The EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments.
Disability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24 Month 24 Participants were considered lesion free at Month 24 if they did not show evidence of GdE lesions at the Month 24 MRI scan.
MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24 Month 24 MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Percent Change From Baseline in Normalized Brain Volume to Month 24 Baseline and Month 24 Brain volume (a measure of brain atrophy) was measured by brain MRI scans that were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test Baseline to Month 24 The MSFC-LCLA is a battery including the following 4 individual scales:
* Timed 25-Foot Walk is an ambulation measure of walking 25 feet with time taken recorded in seconds
* 9-Hole Peg Test (9HPT) is a quantitative measure of upper extremity (arm and hand) function
* Symbol Digit Modalities Test (SDMT) is a measure of executive cognitive function that assesses processing speed, flexibility, and calculation ability
* Low-Contrast Letter Acuity Test (LCLA) used a standardized set of charts to assess low contrast visual acuity, charts are scored according to the number of letters that are identified correctly
Z-scores were calculated for for each component and averaged to create an overall composite score, using the study population as the reference population. A Z-score represents the number of standard deviations a patient's test result is higher (Z \> 0) or lower (Z \< 0) than the average test result (Z = 0) of the reference population. A positive change indicates improvement.Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores Baseline to Month 24 The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. The instrument includes 12 subscales, two summary scores, and two single-item measures.
The two summary scores - physical health and mental health - are derived from a weighted combination of scale scores.
The physical health composite score includes Physical function, Health perceptions, Energy/fatigue, Role limitations - physical, Pain, Sexual function, Social function, and Health distress.
The mental health composite score includes Health distress, Overall quality of life, Emotional well-being, Role limitations - emotional, and Cognitive function.
Each composite summary score has a range from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.Number of Participants With Treatment Emergent Adverse Events From the first dose of study drug up to the first dose of the open-label extension study RPC01-3001, or up to 28 days after last dose for participants who did not continue into the open-label extension study; median duration of treatment was 24 months. An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP), including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.
The investigator assessed the severity of AEs as mild, moderate, or severe and the relationship of each AE to treatment as unrelated, unlikely, possible, probable, or related based on timing and other known factors such as clinical state, environment, or other therapies.
Trial Locations
- Locations (299)
Neurostudies Inc
🇺🇸Port Charlotte, Florida, United States
RESMEDICA Spolka z o.o.
🇵🇱Kielce, Poland
Receptos Study Site 402
🇵🇱Olsztyn, Poland
Receptos Study Site 811
🇺🇦Kherson, Ukraine
Receptos Study Site 252
🇧🇪Montegnée, Belgium
Receptos Study Site 254
🇧🇪Ottignies, Belgium
Clinique Saint Pierre
🇧🇪Ottignies, Belgium
Volyn Regional Clinical Hospital
🇺🇦Lutsk, Ukraine
Receptos Study Site 810
🇺🇦Odesa, Ukraine
Receptos Study Site 104
🇺🇸Cleveland, Ohio, United States
Receptos Study Site 102
🇺🇸Seattle, Washington, United States
The Polyclinic
🇺🇸Seattle, Washington, United States
Receptos Study Site 907
🇧🇾Grodno, Belarus
Receptos Study Site 256
🇧🇪Brugge, Belgium
Receptos Study Site 455
🇧🇬Sofia, Bulgaria
Receptos Study Site 358
🇭🇺Kistarcsa, Hungary
Receptos Study Site 457
🇧🇬Sofia, Bulgaria
Receptos Study Site 119
🇺🇸Tucson, Arizona, United States
Receptos Study Site 115
🇺🇸Phoenix, Arizona, United States
Receptos Study Site 110
🇺🇸Berkeley, California, United States
Receptos Study Site 118
🇺🇸Phoenix, Arizona, United States
Receptos Study Site 902
🇧🇾Minsk, Belarus
Receptos Study Site 905
🇧🇾Vitebsk, Belarus
Xenoscience
🇺🇸Phoenix, Arizona, United States
Receptos Study Site 601
🇷🇸Belgrade, Serbia
Gomel Regional Clinical Hospital
🇧🇾Gomel, Belarus
Receptos Study Site 921
🇭🇷Zagreb, Croatia
Clinical Hospital Centre Zagreb
🇭🇷Zagreb, Croatia
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
🇧🇬Sofia, Bulgaria
Receptos Study Site 456
🇧🇬Sofia, Bulgaria
Receptos Study Site 814
🇺🇦Kharkiv, Ukraine
Grodno Clinical Regional Hospital
🇧🇾Grodno, Belarus
AZ Sint-Jan AV Brugge
🇧🇪Brugge, Belgium
Cliniques Universitaires St Luc
🇧🇪Bruxelles, Belgium
Centre Hospitalier Chretien Clinique Saint Joseph
🇧🇪Montegnee, Belgium
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD
🇧🇬Sofia, Bulgaria
Receptos Study Site 453
🇧🇬Sofia, Bulgaria
Navy Hospital of Athens
🇬🇷Athens, Greece
Georgios Papanikolaou General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Specjalistyczna Praktyka Lekarska Lek Med Robert Bonek
🇵🇱Bydgoszcz, Poland
Receptos Study Site 425
🇵🇱Gdansk, Poland
NovoMed Zielinski i Wspolnicy Spolka Jawna
🇵🇱Katowice, Poland
Receptos Study Site 652
🇮🇹Milano, Italy
Jahn Ferenc DelPesti Korhaz es Rendelointezet
🇭🇺Budapest, Hungary
Receptos Study Site 113
🇺🇸Northbrook, Illinois, United States
Receptos Study Site 356
🇭🇺Budapest, Hungary
Receptos Study Site 355
🇭🇺Szekesfehervar, Hungary
AHEPA University General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Receptos Study Site 557
🇬🇷Thessaloniki, Greece
Receptos Study Site 923
🇭🇷Osijek, Croatia
Receptos Study Site 401
🇵🇱Bialystok, Poland
Receptos Study Site 406
🇵🇱Czeladz, Poland
Receptos Study Site 427
🇵🇱Katowice, Poland
Receptos Study Site 415
🇵🇱Olsztyn, Poland
Receptos Study Site 656
🇮🇹Napoli, Italy
Receptos Study Site 658
🇮🇹Pavia, Italy
SzabolcsSzatmarBereg Megyei Korhazak es Egyetemi Oktatokorhaz
🇭🇺Nyiregyhaza, Hungary
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
🇧🇬Sofia, Bulgaria
Clinical Hospital Center Osijek
🇭🇷Osijek, Croatia
Receptos Study Site 423
🇵🇱Bydgoszcz, Poland
Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
🇵🇱Czeladz, Poland
401 Military Hospital of Athens
🇬🇷Athens, Greece
Receptos Study Site 555
🇬🇷Thessaloniki, Greece
Receptos Study Site 405
🇵🇱Gdansk, Poland
NEUROCARE Site Management Organization Gabriela KlodowskaDuda
🇵🇱Katowice, Poland
Receptos Study Site 654
🇮🇹Catania, Italy
Receptos Study Site 352
🇭🇺Budapest, Hungary
University of Alberta MS Clinic
🇨🇦Edmonton, Alberta, Canada
Receptos Study Site 551
🇬🇷Athens, Greece
Clinical Hospital Sveti duh
🇭🇷Zagreb, Croatia
NEUROMEDIC Janusz Zbrojkiewicz
🇵🇱Katowice, Poland
Receptos Study Site 407
🇵🇱Katowice, Poland
Receptos Study Site 404
🇵🇱Konstancin-Jeziorna, Poland
Pest Megyei Flor Ferenc Korhaz
🇭🇺Kistarcsa, Hungary
Uzsoki Utcai Korhaz
🇭🇺Budapest, Hungary
Receptos Study Site 354
🇭🇺Esztergom, Hungary
Receptos Study Site 351
🇭🇺Nyíregyháza, Hungary
Timisoara Emergency County Clinical Hospital
🇷🇴Timisoara, Romania
Krakowska Akademia Neurologii Sp. z. o.o.
🇵🇱Krakow, Poland
Republican Clinical Hospital for Rehabilitation Treatment
🇷🇺Kazan, Russian Federation
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
🇵🇱Podlaskie, Poland
Centrum Neurologii Krzysztof Selmaj
🇵🇱Lodz, Poland
Receptos Study Site 411
🇵🇱Lodz, Poland
Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
🇵🇱Lublin, Poland
Receptos Study Site 412
🇵🇱Lublin, Poland
Receptos Study Site 703
🇷🇺Novosibirsk, Russian Federation
Receptos Study Site 505
🇷🇴Sibiu, Romania
Research Medical Complex Vashe Zdorovie
🇷🇺Kazan, Russian Federation
Receptos Study Site 956
🇿🇦KwaZulu-Natal, South Africa
Receptos Study Site 701
🇷🇺Chelyabinsk, Russian Federation
Receptos Study Site 716
🇷🇺Samara, Russian Federation
Receptos Study Site 760
🇪🇸Girona, Cataluña, Spain
Yaroslavl Clinical Hospital 8
🇷🇺Yaroslavl, Russian Federation
Receptos Study Site 502
🇷🇴Campulung, Romania
Centralny Szpital Kliniczny MSW w Warszawie
🇵🇱Warszawa, Poland
Receptos Study Site 413
🇵🇱Warszawa, Poland
Receptos Study Site 756
🇪🇸Barcelona, Cataluña, Spain
Receptos Study Site 761
🇪🇸Bilbao, País Vasco, Spain
City neurology center Sibneuromed LLC
🇷🇺Novosibirsk, Russian Federation
Receptos Study Site 603
🇷🇸Belgrade, Serbia
Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital
🇺🇦Chernigiv, Ukraine
Receptos Study Site 704
🇷🇺Kazan, Russian Federation
Receptos Study Site 713
🇷🇺Kazan, Russian Federation
Receptos Study Site 953
🇿🇦Pretoria, South Africa
Neftyanik Medical and Sanitary Unit
🇷🇺Tyumen, Russian Federation
Clinical Hospital Centre Zemun
🇷🇸Belgrade, Serbia
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Receptos Study Site 805
🇺🇦Chernihiv, Ukraine
Receptos Study Site 802
🇺🇦Dnipropetrovsk, Ukraine
Smolensk State Medical Academy
🇷🇺Smolensk, Russian Federation
Receptos Study Site 752
🇪🇸Valencia, Comunidad Valenciana, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Receptos Study Site 758
🇪🇸Barcelona, Spain
Receptos Study Site 605
🇷🇸Kragujevac, Serbia
Receptos Study Site 818
🇺🇦Kyiv, Ukraine
Receptos Study Site 755
🇪🇸Sevilla, Andalucía, Spain
Neurology Practice
🇿🇦Pretoria, South Africa
Kings College Hospital
🇬🇧London, United Kingdom
Fondazione Istituto San Raffaele G Giglio di Cefalu
🇮🇹Cefalu, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
Receptos Study Site 653
🇮🇹Cefalù, Italy
Receptos Study Site 655
🇮🇹Milano, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
Presidio Ospedaliero di Montichiari
🇮🇹Montichiari, Italy
Receptos Study Site 659
🇮🇹Montichiari, Italy
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Receptos Study Site 657
🇮🇹Siena, Italy
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Italy
Receptos Study Site 651
🇮🇹Roma, Italy
Minsk City Clinical Hospital 9
🇧🇾Minsk, Belarus
Receptos Study Site 903
🇧🇾Minsk, Belarus
Vitebsk Regional Diagnostic Centre
🇧🇾Vitebsk, Belarus
Receptos Study Site 946
🇸🇰Bratislava, Slovakia
Clinical Center University of Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
Receptos Study Site 302
🇬🇪Tbilisi, Georgia
Receptos Study Site 931
🇲🇩Chisinau, Moldova, Republic of
Receptos Study Site 506
🇷🇴Timisoara, Romania
Receptos Study Site 604
🇷🇸Belgrade, Serbia
Receptos Study Site 945
🇸🇰Trnava, Slovakia
IMSP Institutul de Medicina Urgenta
🇲🇩Chisinau, Moldova, Republic of
Rehabilitation Clinical Hospital
🇷🇴Cluj-Napoca, Romania
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Receptos Study Site 911
🇧🇦Sarajevo, Bosnia and Herzegovina
Institutul de Neurologie si Neurochirurgie
🇲🇩Chisinau, Moldova, Republic of
Receptos Study Site 503
🇷🇴Brasov, Romania
Health Club Medical Center S.R.L.
🇷🇴Campulung, Romania
Clinical Hospital Centar Zvezdara
🇷🇸Belgrade, Serbia
University Hospital Bratislava - Hospital ak. L. Derera, II Neurology Clinic
🇸🇰Bratislava, Slovakia
Receptos Study Site 933
🇲🇩Chisinau, Moldova, Republic of
Receptos Study Site 501
🇷🇴Cluj-Napoca, Romania
Receptos Study Site 602
🇷🇸Belgrade, Serbia
Receptos Study Site 942
🇸🇰Lucenec, Slovakia
Receptos Study Site 932
🇲🇩Chisinau, Moldova, Republic of
Clinical Hospital of Psychiatry and Neurology Brasov
🇷🇴Brasov, Romania
Military Medical Academy
🇷🇸Belgrade, Serbia
Central Clinical Hospital 2 na NA Semashko OAO RZhD
🇷🇺Moscow, Russian Federation
Receptos Study Site 712
🇷🇺Moscow, Russian Federation
City Clinical Hospital 1 na NIPirogov
🇷🇺Moscow, Russian Federation
Perm State Medical Academy
🇷🇺Perm, Russian Federation
Receptos Study Site 710
🇷🇺Perm, Russian Federation
Samara Regional Clinical Hospital named after MI Kalinin
🇷🇺Samara, Russian Federation
Saratov State Medical University
🇷🇺Saratov, Russian Federation
Receptos Study Site 708
🇷🇺St. Petersburg, Russian Federation
Receptos Study Site 717
🇷🇺Tyumen, Russian Federation
Receptos Study Site 711
🇷🇺Yaroslavl, Russian Federation
Receptos Study Site 454
🇧🇬Sofia, Bulgaria
Receptos Study Site 452
🇧🇬Sofia, Bulgaria
Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
🇧🇬Sofia, Bulgaria
Receptos Study Site 451
🇧🇬Sofia, Bulgaria
City Clinical Hospital 4
🇷🇺Saransk, Russian Federation
Receptos Study Site 715
🇷🇺Saransk, Russian Federation
Receptos Study Site 707
🇷🇺Smolensk, Russian Federation
Receptos Study Site 112
🇺🇸Sacramento, California, United States
Saint Josephs Hosptial and Medical Center
🇺🇸Phoenix, Arizona, United States
Territory Neurology and Research Institute
🇺🇸Tucson, Arizona, United States
Receptos Study Site 122
🇺🇸Long Beach, California, United States
Alta Bates Summit Medical Center
🇺🇸Berkeley, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Multiple Sclerosis Center at UCSF
🇺🇸San Francisco, California, United States
Receptos Study Site 127
🇺🇸Denver, Colorado, United States
Receptos Study Site 120
🇺🇸San Francisco, California, United States
Denver Neurological Research LLC
🇺🇸Denver, Colorado, United States
Neurology Associates PA
🇺🇸Maitland, Florida, United States
Receptos Study Site 114
🇺🇸Maitland, Florida, United States
Receptos Study Site 124
🇺🇸Pompano Beach, Florida, United States
Receptos Study Site 123
🇺🇸Port Charlotte, Florida, United States
Infinity Clinical Research LLC
🇺🇸Sunrise, Florida, United States
West Georgia Sleep Disorder Center and Neurology Associates
🇺🇸Douglasville, Georgia, United States
Consultants In Neurology
🇺🇸Northbrook, Illinois, United States
Receptos Study Site 121
🇺🇸Saint Louis, Missouri, United States
Receptos Study Site 101
🇺🇸Charlotte, North Carolina, United States
Neurology and Neuroscience Associates Inc.
🇺🇸Akron, Ohio, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Receptos Study Site 107
🇺🇸Akron, Ohio, United States
The Neurological Institute PA
🇺🇸Charlotte, North Carolina, United States
Receptos Study Site 109
🇺🇸Philadelphia, Pennsylvania, United States
Receptos Study Site 904
🇧🇾Gomel, Belarus
Receptos Study Site 125
🇺🇸Tacoma, Washington, United States
Minsk Municipal Clinical Hospital 5
🇧🇾Minsk, Belarus
Receptos Study Site 901
🇧🇾Minsk, Belarus
Republican Scientific and Practical Centre of Neurology and Neurosurgery
🇧🇾Minsk, Belarus
Receptos Study Site 255
🇧🇪Brussels, Belgium
Receptos Study Site 906
🇧🇾Vitebsk, Belarus
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
🇧🇬Sofia, Bulgaria
Receptos Study Site 154
🇨🇦Edmonton, Alberta, Canada
Receptos Study Site 922
🇭🇷Zagreb, Croatia
Receptos Study Site 924
🇭🇷Zagreb, Croatia
Clinical Hospital Center "Sestre milosrdnice", Clinic of Internal Diseases
🇭🇷Zagreb, Croatia
Receptos Study Site 301
🇬🇪Tbilisi, Georgia
LTD MediClubGeorgia
🇬🇪Tbilisi, Georgia
Sarajishvili Institute of Neurology
🇬🇪Tbilisi, Georgia
Khechinashvili University Hospital
🇬🇪Tbilisi, Georgia
Receptos Study Site 303
🇬🇪Tbilisi, Georgia
Evaggelismos General Hospital
🇬🇷Athens, Greece
Receptos Study Site 554
🇬🇷Athens, Greece
Receptos Study Site 552
🇬🇷Athens, Greece
MA LEK AM Maciejowscy SC Centrum Terapii SM
🇵🇱Katowice, Poland
Receptos Study Site 553
🇬🇷Athens, Greece
Vaszary Kolos Korhaz
🇭🇺Esztergom, Hungary
Copernicus PL Sp. z. o.o.
🇵🇱Gdansk, Poland
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
🇵🇱Plewiska, Poland
Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak
🇵🇱Pomorskie, Poland
Receptos Study Site 422
🇵🇱Warszawa, Poland
Receptos Study Site 403
🇵🇱Warszawa, Poland
Sibiu Emergency County Clinical Hospital
🇷🇴Sibiu, Romania
Chelyabinsk City Clinical Hospital 3
🇷🇺Chelyabinsk, Russian Federation
Receptos Study Site 709
🇷🇺Moscow, Russian Federation
Receptos Study Site 714
🇷🇺Saratov, Russian Federation
Russian Medical Military Academy na SMKirov
🇷🇺St. Petersburg, Russian Federation
Receptos Study Site 763
🇪🇸Santa Cruz de Tenerife, Canarias, Spain
Receptos Study Site 762
🇪🇸Alicante, Comunidad Valenciana, Spain
Receptos Study Site 759
🇪🇸San Sebastián, País Vasco, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Vall D hebron
🇪🇸Barcelona, Spain
Organizacion Sanitaria Integrada Bilbao Basurto
🇪🇸Bilbao, Spain
Hospital Universitari de Girona Dr Josep Trueta
🇪🇸Girona, Spain
Receptos Study Site 757
🇪🇸Madrid, Spain
Receptos Study Site 751
🇪🇸Madrid, Spain
Receptos Study Site 754
🇪🇸Majadahonda (Madrid), Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Hospital Universitario Vírgen Macarena
🇪🇸Sevilla, Spain
Municipal Institution Chernivtsi Regional Psychiatric Hospital
🇺🇦Chernivtsi, Ukraine
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Receptos Study Site 813
🇺🇦Chernivtsi, Ukraine
Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
🇺🇦Dnipropetrovsk, Ukraine
Receptos Study Site 815
🇺🇦Dnipropetrovsk, Ukraine
Receptos Study Site 801
🇺🇦Ivano-Frankivsk, Ukraine
Municipal Institution Kherson City Clinical Hospital
🇺🇦Kherson, Ukraine
Municipal Institution Lutsk City Clinical Hospital
🇺🇦Lutsk, Ukraine
Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU
🇺🇦Odesa, Ukraine
Receptos Study Site 963
🇬🇧Inverness, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton East Sussex, United Kingdom
Receptos Study Site 965
🇬🇧Brighton, United Kingdom
Raigmore Hospital
🇬🇧Inverness, United Kingdom
Receptos Study Site 961
🇬🇧London, United Kingdom
National Hospital for Neurology and Neurosurgery
🇬🇧London, United Kingdom
Receptos Study Site 967
🇬🇧London, United Kingdom
Receptos Study Site 966
🇬🇧Romford, United Kingdom
Municipal Institution Odesa Regional Clinical Hospital
🇺🇦Odesa, Ukraine
Receptos Study Site 964
🇬🇧Sheffield, United Kingdom
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
🇬🇧Sheffield, United Kingdom
Receptos Study Site 417
🇵🇱Katowice, Poland
Wojewodzki Szpital Specjalistyczny
🇵🇱Olsztyn, Poland
Receptos Study Site 408
🇵🇱Poznan, Poland
Receptos Study Site 426
🇵🇱Katowice, Poland
Receptos Study Site 424
🇵🇱Kielce, Poland
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
🇵🇱Lublin, Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
🇵🇱Poznan, Poland
Receptos Study Site 419
🇵🇱Szczecin, Poland
Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
🇵🇱Warsaw, Poland
Instytut Psychiatrii i Neurologii
🇵🇱Warszawa, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
🇵🇱Warminsko-mazurskie, Poland
Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny
🇵🇱Konstancin Jeziorna, Poland
Receptos Study Site 414
🇵🇱Krakow, Poland
Receptos Study Site 420
🇵🇱Lublin, Poland
Receptos Study Site 421
🇵🇱Plewiska, Poland
Receptos Study Site 428
🇵🇱Warszawa, Poland
Szpital Kliniczny im HSwiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu
🇵🇱Poznan, Poland
Receptos Study Site 418
🇵🇱Poznan, Poland
EUROMEDIS Sp. z.o.o.
🇵🇱Szczecin, Poland
Receptos Study Site 410
🇵🇱Warszawa, Poland
Centrum Medyczne NeuroProtect
🇵🇱Warszawa, Poland
Wojskowy Instytut Medyczny
🇵🇱Warszawa, Poland
Receptos Study Site 804
🇺🇦Odesa, Ukraine
Receptos Study Site 809
🇺🇦Vinnytsya, Ukraine
State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
🇺🇦Kharkiv, Ukraine
Kyiv City Clinical Hospital 4
🇺🇦Kyiv, Ukraine
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
🇺🇦Kyiv, Ukraine
Receptos Study Site 817
🇺🇦Lutsk, Ukraine
Lviv Regional Clinical Hospital
🇺🇦Lviv, Ukraine
Receptos Study Site 812
🇺🇦Lviv, Ukraine
Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko
🇺🇦Vinnytsya, Ukraine
State Institution Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine
🇺🇦Dnipropetrovsk, Ukraine
Regional Clinical Hospital
🇺🇦Ivano Frankivsk, Ukraine
Receptos Study Site 803
🇺🇦Kyiv, Ukraine
Receptos Study Site 816
🇺🇦Lutsk, Ukraine
Municipal Institution City Clinical Hospital 6
🇺🇦Zaporizhzhya, Ukraine
Receptos Study Site 806
🇺🇦Zaporizhzhya, Ukraine