A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
NCT ID: NCT01081782
Last Updated: 2013-12-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
407 participants
INTERVENTIONAL
2010-03-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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E1
ONO-4641
0.15 mg once per day for 26 weeks
E2
ONO-4641
0.1 mg once per day for 26 weeks
E3
ONO-4641
0.05 mg once per day for 26 weeks
P
ONO-4641 placebo
Placebo once per day for 26 weeks
Interventions
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ONO-4641
0.15 mg once per day for 26 weeks
ONO-4641
0.1 mg once per day for 26 weeks
ONO-4641
0.05 mg once per day for 26 weeks
ONO-4641 placebo
Placebo once per day for 26 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis
Exclusion Criteria
* 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)
18 Years
55 Years
ALL
No
Sponsors
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Ono Pharma USA Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Ono Pharma USA, Inc.
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Tucson Clinical Site 133
Tucson, Arizona, United States
Aurora Clinical Site 132
Aurora, Colorado, United States
Fort Collins Clinical Site 123
Fort Collins, Colorado, United States
Fairfield Clinical Site 110
Fairfield, Connecticut, United States
Ormond Beach Clinical Site 129
Ormond Beach, Florida, United States
Sarasota Clinical Site 116
Sarasota, Florida, United States
Sarasota Clinical Site 117
Sarasota, Florida, United States
Northbrook Clinical Site 135
Northbrook, Illinois, United States
Fort Wayne Clinical Site 111
Fort Wayne, Indiana, United States
Indianapolis Clinical Site 121
Indianapolis, Indiana, United States
Detroit Clinical Site 104
Detroit, Michigan, United States
Farmington Hills Clinical Site 126
Farmington Hills, Michigan, United States
Lebanon Clinical Site 115
Lebanon, New Hampshire, United States
Albuquerque Clinical Site 106
Albuquerque, New Mexico, United States
Rochester Clinical Site 108
Rochester, New York, United States
Charlotte Clinical Site 125
Charlotte, North Carolina, United States
HighPoint Clinical Site 128
HighPoint, North Carolina, United States
Raleigh Clinical Site 103
Raleigh, North Carolina, United States
Akron Clinical Site 112
Akron, Ohio, United States
Philadelphia Clinical Site 120
Philadelphia, Pennsylvania, United States
Knoxville Clinical Site 134
Knoxville, Tennessee, United States
Round Rock Clinical Site 107
Round Rock, Texas, United States
Seattle Clinical Site 118
Seattle, Washington, United States
Brugge Clinical Site 203
Bruges, , Belgium
La Louviere Clinical Site 201
La Louvière, , Belgium
Sijsele Clinical Site 202
Sijsele, , Belgium
Gatineau Clinical Site 114
Gatineau, Quebec, Canada
Greenfield Park Clinical Site 109
Greenfield Park, Quebec, Canada
Vancouver Clinical Site 131
British Columbia, , Canada
Montreal Clinical Site 113
Québec, , Canada
Montreal Clinical Site 102
Québec, , Canada
Olomouc Clinical Site 212
Olomouc, , Czechia
Ostrava Clinical Site 214
Ostrava, , Czechia
Pardubice Clinical Site 211
Pardubice, , Czechia
Praha 5 Clinical Site 213
Prague, , Czechia
Berlin Clinical Site 223
Berlin, , Germany
Essen Clinical Site 222
Essen, , Germany
Giessen Clinical Site 221
Giessen, , Germany
Leipzig Clinical Site 229
Leipzig, , Germany
Mainz Clinical Site 231
Mainz, , Germany
Marburg Clinical Site 228
Marburg, , Germany
Munster Clinical Site 225
Münster, , Germany
Tubingen Clinical Site 226
Tübingen, , Germany
Ulm Clinical Site 230
Ulm, , Germany
Athens Clinical Site 243
Athens, , Greece
Thessaloniki Clinical Site 245
Thessaloniki, , Greece
Kanto Region Clinical Site 404
Kanto, , Japan
Kanto Region Clinical Site 405
Kanto, , Japan
Kanto Region Clinical Site 406
Kanto, , Japan
Kanto Region Clinical Site 409
Kanto, , Japan
Kinki Region Clinical Site 401
Kinki, , Japan
Kinki Region Clinical Site 407
Kinki, , Japan
Kinki Region Clinical Site 408
Kinki, , Japan
Tohoku Region Clinical Site 403
Tōhoku, , Japan
Tohoku Region Clinical Site 410
Tōhoku, , Japan
Bialystok Clinical Site 305
Bialystok, , Poland
Czeladz Clinical Site 303
Czeladź, , Poland
Gdansk Clinical Site 302
Gdansk, , Poland
Katowice Clinical Site 309
Katowice, , Poland
Krakow Clinical Site 307
Krakow, , Poland
Lodz Clinical Site 306
Lodz, , Poland
Plewiska Clinical Site 304
Plewiska, , Poland
Warszawa Clinical Site 308
Warsaw, , Poland
Chelyabinsk Clinical Site 322
Chelyabinsk, , Russia
Kaluga Clinical Site 328
Kaluga, , Russia
Kazan Clinical Site 333
Kazan', , Russia
Moscow Clinical Site 332
Moscow, , Russia
Nizhniy Novgorod Clinical Site 321
Nizhny Novgorod, , Russia
Novosibirsk Clinical Site 324
Novosibirsk, , Russia
St. Petersburg Clinical Site 325
Saint Petersburg, , Russia
St. Petersburg Clinical Site 327
Saint Petersburg, , Russia
Samara Clinical Site 328
Samara, , Russia
Ufa Clinical Site 326
Ufa, , Russia
Yaroslavl Clinical Site 331
Yaroslavl, , Russia
Barcelona Clinical Site 252
Barcelona, , Spain
Barcelona Clinical Site 253
Barcelona, , Spain
Bilbao Clinical Site 255
Bilbao, , Spain
Girona Clinical Site 254
Girona, , Spain
Hospitalet de Llobregat Clinical Site 251
L'Hospitalet de Llobregat, , Spain
Sevilla Clinical Site 256
Seville, , Spain
Dnipropetrovsk Clinical Site 341
Dnipropetrovsk, , Ukraine
Donetsk Clinical Site 345
Donetsk, , Ukraine
Kharkiv Clinical Site 346
Kharkiv, , Ukraine
Kyiv Clinical Site 344
Kyiv, , Ukraine
Lviv Clinical Site 343
Lviv, , Ukraine
Vinnytsya Clinical Site 342
Vinnytsia, , Ukraine
Countries
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Other Identifiers
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ONO-4641POU006
Identifier Type: -
Identifier Source: org_study_id