Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Drug: ACT-128800 Dose 1Drug: ACT-128800 Dose 2Drug: ACT-128800 Dose 3Drug: Placebo
- Registration Number
- NCT01006265
- Lead Sponsor
- Actelion
- Brief Summary
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 464
- Adult males and females
- Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS).
- Signed inform consent prior to initiation of any study-mandated procedure.
- A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing.
- Patients currently treated for an autoimmune disorder other than MS.
- Contraindications for MRI.
- Ongoing bacterial, viral, or fungal infection.
- History or presence of malignancy.
Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACT-128800 Dose 1 ACT-128800 Dose 1 ACT-128800 Dose 1 ACT-128800 Dose 2 ACT-128800 Dose 2 ACT-128800 Dose 2 ACT-128800 Dose 3 ACT-128800 Dose 3 ACT-128800 Dose 3 Placebo Placebo Matching placebo
- Primary Outcome Measures
Name Time Method Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24 From Week 12 to 24 Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.
- Secondary Outcome Measures
Name Time Method Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24 Baseline to Week 24 Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of MS, not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS). Kaplan-Meier estimate used for Outcome Measure analysis.
Annualized Confirmed Relapse Rate Up to 24 weeks Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple Sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS)
Trial Locations
- Locations (115)
Clinical Investigative Site 3118
🇺🇸Baltimore, Maryland, United States
Clinical Investigative Site # 3135
🇺🇸Newark, New Jersey, United States
Clinical Investigative Site 3130
🇺🇸Columbus, Ohio, United States
Clinical Investigative Site 1601
🇫🇮Hyvinkaa, Finland
Clinical Investigative Site 1602
🇫🇮Turku, Finland
Clinical Investigative Site 2302
🇵🇱Wroclaw, Poland
Clinical Investigative Site # 1904
ðŸ‡ðŸ‡ºBudapest, Hungary
Clinical Investigative Site 3101
🇺🇸Indianapolis, Indiana, United States
Clinical Investigative Site # 3128
🇺🇸New York, New York, United States
Clinical Investigative Site 3127
🇺🇸Schenectady, New York, United States
Clinical Investigative Site 1503
🇨🇿Teplice, Czechia
Clinical Investigative Site 3113
🇺🇸Cincinnati, Ohio, United States
Clinical Investigative Site 3209
🇷🇺Saratov, Russian Federation
Clinical Investigative Site 2800
🇸🇪Stockholm, Sweden
Clinical Investigative Site 3107
🇺🇸Lenexa, Kansas, United States
Clinical Investigative Site 3132
🇺🇸Scottsdale, Arizona, United States
Clinical Investigative Site 3105
🇺🇸Kansas City, Kansas, United States
Clinical Invesigative Site 3116
🇺🇸Sarasota, Florida, United States
Clinical Investigative Site 3100
🇺🇸Tucson, Arizona, United States
Clinical Investigative Site 3115
🇺🇸Sacramento, California, United States
Clinical Investigative Site 3117
🇺🇸Stanford, California, United States
Clinical Investigative Site 3133
🇺🇸Worcester, Massachusetts, United States
Clinical Investigator 3136
🇺🇸Saint Louis, Missouri, United States
Clinical Investigative Site 3119
🇺🇸Raleigh, North Carolina, United States
Clinical Investigator 3126
🇺🇸Akron, Ohio, United States
Clinical Investigative Site 3120
🇺🇸Stony Brook, New York, United States
Clinical Investigative Site 3129
🇺🇸Latham, New York, United States
Clinical Investigative Site 1100
🇦🇹St Polten, Austria
Clinical Investigator 3104
🇺🇸Portland, Oregon, United States
Clinical Investigative Site 3111
🇺🇸Richmond, Virginia, United States
Clinical Investigative Site 3125
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Investigative Site 3112
🇺🇸Burlington, Vermont, United States
Clinical Investigative Site 3102
🇺🇸Kirkland, Washington, United States
Clinical Investigative Site 1102
🇦🇹Amstetten, Austria
Clinical Investigative Site # 1001
🇦🇺Fitzroy, Australia
Clinical Investigative Site 1000
🇦🇺Westmead, Australia
Clinical Investigative Site 1101
🇦🇹Vienna, Austria
Clinical Investigative Site 1201
🇧🇪La Louviere, Belgium
Clinical Investigative Site 1204
🇧🇪Ottignies, Belgium
Clinical Investigative Site 1203
🇧🇪Sijsele-Damme, Belgium
Clinical Investigative Site # 1205
🇧🇪Liege, Belgium
Clinical Investigative Site 1302
🇧🇬Sofia, Bulgaria
Clinical Investigative Site 1301
🇧🇬Sofia, Bulgaria
Clinical Investigative Site 1401
🇨🇦Burbaby, British Columbia, Canada
Clinical Investigative Site 1304
🇧🇬Varna, Bulgaria
Clinical Investigative Site 1303
🇧🇬Varna, Bulgaria
Clinical Investigative Site 1400
🇨🇦Ottawa, Canada
Clinical Investigative Site 1504
🇨🇿Olomouc, Czechia
Clinical Investigative Site 1502
🇨🇿Brno, Czechia
Clinical Investigative Site # 1401
🇨🇦Burnaby, Canada
Clinical Investigative Site 1506
🇨🇿Jihlava, Czechia
Clinical Investigative Site 1500
🇨🇿Praha, Czechia
Clinical Investigative Site 1501
🇨🇿Ostrava-Poruba, Czechia
Clinical Investigative Site 1600
🇫🇮Helsinki, Finland
Clinical Investigative Site 1603
🇫🇮Tampere, Finland
Clinical Investigative Site 1701
🇫🇷Montpellier Cedex, France
Clinical Investigative Site # 1806
🇩🇪Bayreuth, Germany
Clinical Investigative 1807
🇩🇪Berlin, Germany
Clinical Investigative Site 1802
🇩🇪Essen, Germany
Clinical Investigative Site 1803
🇩🇪Berlin, Germany
Clinical Investigative site 1800
🇩🇪Dusseldorf, Germany
Clinical Investigative Site 2203
🇳🇱Breda, Netherlands
Clinical Investigative Site 1804
🇩🇪Ulm, Germany
Clinical Investigative Site 1805
🇩🇪Homburg/Saar, Germany
Clinical Investigative Site 1905
ðŸ‡ðŸ‡ºBudapest, Hungary
Clinical Investigative Site 1908
ðŸ‡ðŸ‡ºBudapest, Hungary
Clinical Investigative Site 1902
ðŸ‡ðŸ‡ºGyor, Hungary
Clinical Investigative Site 1900
ðŸ‡ðŸ‡ºPetofi, Hungary
Clinical Investigative Site 1901
ðŸ‡ðŸ‡ºSzentpeteri-Kapu, Hungary
Clinical Investigative Site 2000
🇮🇱Ashkelon, Israel
Clinical Investigative Site 2003
🇮🇱Tel-Aviv, Israel
Clinical Investigative Site 2104
🇮🇹Genova, Italy
Clinical Investigative Site 2001
🇮🇱Tel-Hashomer, Israel
Clinical Investigative Site 2002
🇮🇱Zerifin, Israel
Clinical Investigative Site 2101
🇮🇹Gallarte, Italy
Clinical Investigative Site # 2106
🇮🇹Milan, Italy
Clinical Investigative Site 2102
🇮🇹Padova, Italy
Clinical Investigative Site 2202
🇳🇱Nijmegen, Netherlands
Clinical Investigative Site 2103
🇮🇹Roma, Italy
Clinical Investigative Site 2105
🇮🇹Siena, Italy
Clinical Investigative Site 2305
🇵🇱Katowice, Poland
Clinical Investigative Site 2201
🇳🇱Sittard-Geleen, Netherlands
Clinical Investigative Site 2304
🇵🇱Warsaw, Poland
Clinical Investigative Site 2303
🇵🇱Poznan, Poland
Clinical Investigative Site 2400
🇷🇴Bucuresti, Romania
Clinical Investigative Site 2401
🇷🇴Cluj-Napoca, Romania
Clinical Investigative Site 2402
🇷🇴Timisoara, Romania
Clinical Investigative Site # 3202
🇷🇺Moscow, Russian Federation
Clinical Investigative Site # 3203
🇷🇺Nizhniy Novgorod, Russian Federation
Clinical Investigative Site # 3201
🇷🇺Samara, Russian Federation
Clinical Investigative Site # 3206
🇷🇺Pyatigorsk, Russian Federation
Clinical Investigative Site # 3204
🇷🇺St. Petersburg, Russian Federation
Clinical Investigative Site 3201
🇷🇺St. Petersburg, Russian Federation
Clinical Investigative Site 3200
🇷🇺St. Petersburg, Russian Federation
Clinical Investigative Site 3208
🇷🇺Ufa, Russian Federation
Clinical Investigative Site 2503
🇷🇸Kragujevac, Serbia
Clinical Investigative Site 2501
🇷🇸Belgrade, Serbia
Clinical Investigative Site 2502
🇷🇸Nis, Serbia
Clinical Investigative Site 2706
🇪🇸Barcelona, Spain
Clinical Investigative Site 2701
🇪🇸Malaga, Spain
Clinical Investigative Site 2702
🇪🇸Madrid, Spain
Clinical Investigative Site 2700
🇪🇸Sevilla, Spain
Clinical Investigative Site 2704
🇪🇸Valencia, Spain
Clinical Investigative Site 2802
🇸🇪Goteburg, Sweden
Clinical Investigative Site 2901
🇨ðŸ‡Lugano, Switzerland
Clinical Investigative Site 2801
🇸🇪Umed, Sweden
Clinical Investigative Site 2900
🇨ðŸ‡St Gallen, Switzerland
Clinical Investigative Site 3302
🇺🇦Chernihiv, Ukraine
Clinical Investigative Site 3300
🇺🇦Kyiv, Ukraine
Clinical Investigative Site 3303
🇺🇦Dnipropetrovsk, Ukraine
Clinical Investigative Site 3004
🇬🇧Devon, United Kingdom
Clinical Investigative Site 3304
🇺🇦Odesa, Ukraine
Clinical Investigative Site 3002
🇬🇧London, United Kingdom
Clinical Investigative Site 3003
🇬🇧Bristol, United Kingdom
Clinical Investigative Site 2705
🇪🇸Madrid, Spain