A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
- Registration Number
- NCT01081782
- Lead Sponsor
- Ono Pharma USA Inc
- Brief Summary
The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis over a 26-week treatment period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
- Adult male or female aged 18-55 years inclusive at screening
- Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis
- Multiple Sclerosis course other than relapsing-remitting multiple sclerosis
- History of malignancy
- History of clinically significant chronic disease of the immune system (other than Multiple Sclerosis)
- Inability to undergo Gd-enhanced MRI scans
- Diagnosis of diabetes mellitus (type I or type II)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E1 ONO-4641 - E3 ONO-4641 - P ONO-4641 placebo - E2 ONO-4641 -
- Primary Outcome Measures
Name Time Method Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks. 26 weeks
- Secondary Outcome Measures
Name Time Method Total volume of Gd-enhanced lesions 26 weeks
Trial Locations
- Locations (86)
Donetsk Clinical Site 345
🇺🇦Donetsk, Ukraine
Tucson Clinical Site 133
🇺🇸Tucson, Arizona, United States
Aurora Clinical Site 132
🇺🇸Aurora, Colorado, United States
Sarasota Clinical Site 116
🇺🇸Sarasota, Florida, United States
Lebanon Clinical Site 115
🇺🇸Lebanon, New Hampshire, United States
Northbrook Clinical Site 135
🇺🇸Northbrook, Illinois, United States
Sarasota Clinical Site 117
🇺🇸Sarasota, Florida, United States
Round Rock Clinical Site 107
🇺🇸Round Rock, Texas, United States
Fairfield Clinical Site 110
🇺🇸Fairfield, Connecticut, United States
Warszawa Clinical Site 308
🇵🇱Warszawa, Poland
Kanto Region Clinical Site 406
🇯🇵Kanto, Japan
Fort Collins Clinical Site 123
🇺🇸Fort Collins, Colorado, United States
Yaroslavl Clinical Site 331
🇷🇺Yaroslavl, Russian Federation
Ufa Clinical Site 326
🇷🇺Ufa, Russian Federation
Farmington Hills Clinical Site 126
🇺🇸Farmington Hills, Michigan, United States
Knoxville Clinical Site 134
🇺🇸Knoxville, Tennessee, United States
Philadelphia Clinical Site 120
🇺🇸Philadelphia, Pennsylvania, United States
Bialystok Clinical Site 305
🇵🇱Bialystok, Poland
Czeladz Clinical Site 303
🇵🇱Czeladz, Poland
Gdansk Clinical Site 302
🇵🇱Gdansk, Poland
Chelyabinsk Clinical Site 322
🇷🇺Chelyabinsk, Russian Federation
Montreal Clinical Site 102
🇨🇦Quebec, Canada
Kinki Region Clinical Site 401
🇯🇵Kinki, Japan
Essen Clinical Site 222
🇩🇪Essen, Germany
Tohoku Region Clinical Site 403
🇯🇵Tohoku, Japan
Akron Clinical Site 112
🇺🇸Akron, Ohio, United States
Olomouc Clinical Site 212
🇨🇿Olomouc, Czech Republic
Lodz Clinical Site 306
🇵🇱Lodz, Poland
Ormond Beach Clinical Site 129
🇺🇸Ormond Beach, Florida, United States
Mainz Clinical Site 231
🇩🇪Mainz, Germany
Montreal Clinical Site 113
🇨🇦Quebec, Canada
Kanto Region Clinical Site 409
🇯🇵Kanto, Japan
Kinki Region Clinical Site 407
🇯🇵Kinki, Japan
Moscow Clinical Site 332
🇷🇺Moscow, Russian Federation
Giessen Clinical Site 221
🇩🇪Giessen, Germany
Tohoku Region Clinical Site 410
🇯🇵Tohoku, Japan
Vancouver Clinical Site 131
🇨🇦British Columbia, Canada
Katowice Clinical Site 309
🇵🇱Katowice, Poland
Kinki Region Clinical Site 408
🇯🇵Kinki, Japan
Tubingen Clinical Site 226
🇩🇪Tubingen, Germany
Greenfield Park Clinical Site 109
🇨🇦Greenfield Park, Quebec, Canada
Kyiv Clinical Site 344
🇺🇦Kyiv, Ukraine
Vinnytsya Clinical Site 342
🇺🇦Vinnytsya, Ukraine
Girona Clinical Site 254
🇪🇸Girona, Spain
Seattle Clinical Site 118
🇺🇸Seattle, Washington, United States
Brugge Clinical Site 203
🇧🇪Brugge, Belgium
La Louviere Clinical Site 201
🇧🇪La Louviere, Belgium
Sijsele Clinical Site 202
🇧🇪Sijsele, Belgium
Detroit Clinical Site 104
🇺🇸Detroit, Michigan, United States
Berlin Clinical Site 223
🇩🇪Berlin, Germany
Thessaloniki Clinical Site 245
🇬🇷Thessaloniki, Greece
Fort Wayne Clinical Site 111
🇺🇸Fort Wayne, Indiana, United States
Indianapolis Clinical Site 121
🇺🇸Indianapolis, Indiana, United States
Rochester Clinical Site 108
🇺🇸Rochester, New York, United States
HighPoint Clinical Site 128
🇺🇸HighPoint, North Carolina, United States
Albuquerque Clinical Site 106
🇺🇸Albuquerque, New Mexico, United States
Gatineau Clinical Site 114
🇨🇦Gatineau, Quebec, Canada
Praha 5 Clinical Site 213
🇨🇿Praha 5, Czech Republic
Athens Clinical Site 243
🇬🇷Athens, Greece
Kanto Region Clinical Site 404
🇯🇵Kanto, Japan
Marburg Clinical Site 228
🇩🇪Marburg, Germany
Leipzig Clinical Site 229
🇩🇪Leipzig, Germany
Munster Clinical Site 225
🇩🇪Munster, Germany
Kanto Region Clinical Site 405
🇯🇵Kanto, Japan
Ulm Clinical Site 230
🇩🇪Ulm, Germany
Plewiska Clinical Site 304
🇵🇱Plewiska, Poland
Krakow Clinical Site 307
🇵🇱Krakow, Poland
Novosibirsk Clinical Site 324
🇷🇺Novosibirsk, Russian Federation
St. Petersburg Clinical Site 325
🇷🇺St. Petersburg, Russian Federation
Kaluga Clinical Site 328
🇷🇺Kaluga, Russian Federation
Kazan Clinical Site 333
🇷🇺Kazan, Russian Federation
Nizhniy Novgorod Clinical Site 321
🇷🇺Nizhniy Novgorod, Russian Federation
St. Petersburg Clinical Site 327
🇷🇺St. Petersburg, Russian Federation
Samara Clinical Site 328
🇷🇺Samara, Russian Federation
Barcelona Clinical Site 253
🇪🇸Barcelona, Spain
Bilbao Clinical Site 255
🇪🇸Bilbao, Spain
Hospitalet de Llobregat Clinical Site 251
🇪🇸Hospitalet de Llobregat, Spain
Barcelona Clinical Site 252
🇪🇸Barcelona, Spain
Sevilla Clinical Site 256
🇪🇸Sevilla, Spain
Dnipropetrovsk Clinical Site 341
🇺🇦Dnipropetrovsk, Ukraine
Lviv Clinical Site 343
🇺🇦Lviv, Ukraine
Charlotte Clinical Site 125
🇺🇸Charlotte, North Carolina, United States
Raleigh Clinical Site 103
🇺🇸Raleigh, North Carolina, United States
Pardubice Clinical Site 211
🇨🇿Pardubice, Czech Republic
Ostrava Clinical Site 214
🇨🇿Ostrava, Czech Republic
Kharkiv Clinical Site 346
🇺🇦Kharkiv, Ukraine