Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
NCT ID: NCT01226745
Last Updated: 2016-07-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
340 participants
INTERVENTIONAL
2010-10-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ONO-4641 0.15 milligram (mg) - 0.15 mg
ONO-4641
Subjects will be administered with ONO-4641 at a dose of 0.15 milligram (mg) in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.
ONO-4641 0.10 mg - 0.10 mg
ONO-4641
Subjects will be administered with ONO-4641 at a dose of 0.10 mg in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.
ONO-4641 0.05 mg - 0.05 mg
ONO-4641
Subjects will be administered with ONO-4641 at a dose of 0.05 mg in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.
Placebo - ONO4641 0.15 mg
ONO-4641
Subjects will receive placebo in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.
Placebo - ONO4641 0.10 mg
ONO-4641
Subjects will receive placebo in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.
Placebo - ONO4641 0.05 mg
ONO-4641
Subjects will receive placebo in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.
Interventions
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ONO-4641
Subjects will be administered with ONO-4641 at a dose of 0.15 milligram (mg) in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.
ONO-4641
Subjects will be administered with ONO-4641 at a dose of 0.10 mg in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.
ONO-4641
Subjects will be administered with ONO-4641 at a dose of 0.05 mg in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.
ONO-4641
Subjects will receive placebo in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.
ONO-4641
Subjects will receive placebo in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.
ONO-4641
Subjects will receive placebo in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
55 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Ono Pharmaceutical Co. Ltd
INDUSTRY
EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Medical Responsible
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
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
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
Brugge Clinical Site 203
Bruges, , Belgium
La Louviere Clinical Site 201
La Louvière, , Belgium
Vancouver Clinical Site 131
Vancouver, British Columbia, Canada
Gatineau Clinical Site 114
Gatineau, Quebec, Canada
Greenfield park Clinical Site 109
Greenfield Park, Quebec, Canada
Montreal Clinical Site 101
Montreal, Quebec, Canada
Montreal Clinical Site 102
Montreal, , Canada
Olomouc Clinical Site 212
Olomouc, , Czechia
Pardubice Clinical Site 211
Pardubice, , Czechia
Praha 5 Clinical Site 213
Prague, , Czechia
Glessen Clinical Site 221
Glessen, , Germany
Leipzig Clinical Site 229
Leipzig, , Germany
Marburg Clinical Site 228
Marburg, , Germany
Tubingen Clinical Site 226
Tübingen, , Germany
Athens Clinical Site 243
Athens, , 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
Kazan Clinical Site 333
Kazan', , Russia
Moscow Clinical Site 332
Moscow, , Russia
Moscow Clinical Site 330
Moscow, , Russia
Nizhniy Novgorod Clinical Site 321
Nizhny Novgorod, , Russia
Novosibirsk Clinical Site 324
Novosibirsk, , Russia
St. Petersburg Clinical Site 325
Saint Petersburg, , Russia
Samara Clinical Site 329
Samara, , Russia
Ufa Clinical Site 326
Ufa, , 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
Kyiv Clinical Site 344
Kyiv, , Ukraine
Lviv Clinical Site 343
Lviv, , Ukraine
Vinnytsya Clinical Site 342
Vinnytsia, , Ukraine
Countries
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References
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Effect of Ceralifimod (ONO-4641), a Sphingosine-1-Phosphate Receptor-1 and -5 Agonist, on Magnetic Resonance Imaging Outcomes in Patients with Multiple Sclerosis: Interim Results from the Extension of the DreaMS Study (P3.161) Amit Bar-Or, Frauke Zipp, Matthew Scaramozza, Timothy Vollmer, Bryan Due, Karthinathan Thangavelu, Tanya Fischer, and Krzysztof Selmaj April 8, 2014 82:10 Supplement P3.161; 1526-632X
Other Identifiers
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2010-018705-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ONO-4641POU007 (EMR200559-002)
Identifier Type: -
Identifier Source: org_study_id
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