Clinical trial NCT01081782: A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
Official title: A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
ONO-4641
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Adult male or female aged 18-55 years inclusive at screening
* Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.
timeFrame: 26 weeks
Secondary outcomes:
measure: Total volume of Gd-enhanced lesions
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Clinical Site 133
state: Arizona
city: Aurora
country: United States
facility: Aurora Clinical Site 132
state: Colorado
city: Fort Collins
country: United States
facility: Fort Collins Clinical Site 123
state: Colorado
city: Fairfield
country: United States
facility: Fairfield Clinical Site 110
state: Connecticut
city: Ormond Beach
country: United States
facility: Ormond Beach Clinical Site 129
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Site 116
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Site 117
state: Florida
city: Northbrook
country: United States
facility: Northbrook Clinical Site 135
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Clinical Site 111
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Clinical Site 121
state: Indiana
city: Detroit
country: United States
facility: Detroit Clinical Site 104
state: Michigan
city: Farmington Hills
country: United States
facility: Farmington Hills Clinical Site 126
state: Michigan
city: Lebanon
country: United States
facility: Lebanon Clinical Site 115
state: New Hampshire
city: Albuquerque
country: United States
facility: Albuquerque Clinical Site 106
state: New Mexico
city: Rochester
country: United States
facility: Rochester Clinical Site 108
state: New York
city: Charlotte
country: United States
facility: Charlotte Clinical Site 125
state: North Carolina
city: HighPoint
country: United States
facility: HighPoint Clinical Site 128
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Clinical Site 103
state: North Carolina
city: Akron
country: United States
facility: Akron Clinical Site 112
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia Clinical Site 120
state: Pennsylvania
city: Knoxville
country: United States
facility: Knoxville Clinical Site 134
state: Tennessee
city: Round Rock
country: United States
facility: Round Rock Clinical Site 107
state: Texas
city: Seattle
country: United States
facility: Seattle Clinical Site 118
state: Washington
city: Brugge
country: Belgium
facility: Brugge Clinical Site 203
city: La Louviere
country: Belgium
facility: La Louviere Clinical Site 201
city: Sijsele
country: Belgium
facility: Sijsele Clinical Site 202
city: Gatineau
country: Canada
facility: Gatineau Clinical Site 114
state: Quebec
city: Greenfield Park
country: Canada
facility: Greenfield Park Clinical Site 109
state: Quebec
city: British Columbia
country: Canada
facility: Vancouver Clinical Site 131
city: Quebec
country: Canada
facility: Montreal Clinical Site 113
city: Quebec
country: Canada
facility: Montreal Clinical Site 102
city: Olomouc
country: Czech Republic
facility: Olomouc Clinical Site 212
city: Ostrava
country: Czech Republic
facility: Ostrava Clinical Site 214
city: Pardubice
country: Czech Republic
facility: Pardubice Clinical Site 211
city: Praha 5
country: Czech Republic
facility: Praha 5 Clinical Site 213
city: Berlin
country: Germany
facility: Berlin Clinical Site 223
city: Essen
country: Germany
facility: Essen Clinical Site 222
city: Giessen
country: Germany
facility: Giessen Clinical Site 221
city: Leipzig
country: Germany
facility: Leipzig Clinical Site 229
city: Mainz
country: Germany
facility: Mainz Clinical Site 231
city: Marburg
country: Germany
facility: Marburg Clinical Site 228
city: Munster
country: Germany
facility: Munster Clinical Site 225
city: Tubingen
country: Germany
facility: Tubingen Clinical Site 226
city: Ulm
country: Germany
facility: Ulm Clinical Site 230
city: Athens
country: Greece
facility: Athens Clinical Site 243
city: Thessaloniki
country: Greece
facility: Thessaloniki Clinical Site 245
city: Kanto
country: Japan
facility: Kanto Region Clinical Site 404
city: Kanto
country: Japan
facility: Kanto Region Clinical Site 405
city: Kanto
country: Japan
facility: Kanto Region Clinical Site 406
city: Kanto
country: Japan
facility: Kanto Region Clinical Site 409
city: Kinki
country: Japan
facility: Kinki Region Clinical Site 401
city: Kinki
country: Japan
facility: Kinki Region Clinical Site 407
city: Kinki
country: Japan
facility: Kinki Region Clinical Site 408
city: Tohoku
country: Japan
facility: Tohoku Region Clinical Site 403
city: Tohoku
country: Japan
facility: Tohoku Region Clinical Site 410
city: Bialystok
country: Poland
facility: Bialystok Clinical Site 305
city: Czeladz
country: Poland
facility: Czeladz Clinical Site 303
city: Gdansk
country: Poland
facility: Gdansk Clinical Site 302
city: Katowice
country: Poland
facility: Katowice Clinical Site 309
city: Krakow
country: Poland
facility: Krakow Clinical Site 307
city: Lodz
country: Poland
facility: Lodz Clinical Site 306
city: Plewiska
country: Poland
facility: Plewiska Clinical Site 304
city: Warszawa
country: Poland
facility: Warszawa Clinical Site 308
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Clinical Site 322
city: Kaluga
country: Russian Federation
facility: Kaluga Clinical Site 328
city: Kazan
country: Russian Federation
facility: Kazan Clinical Site 333
city: Moscow
country: Russian Federation
facility: Moscow Clinical Site 332
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Clinical Site 321
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Clinical Site 324
city: Samara
country: Russian Federation
facility: Samara Clinical Site 328
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Site 325
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Site 327
city: Ufa
country: Russian Federation
facility: Ufa Clinical Site 326
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Clinical Site 331
city: Barcelona
country: Spain
facility: Barcelona Clinical Site 252
city: Barcelona
country: Spain
facility: Barcelona Clinical Site 253
city: Bilbao
country: Spain
facility: Bilbao Clinical Site 255
city: Girona
country: Spain
facility: Girona Clinical Site 254
city: Hospitalet de Llobregat
country: Spain
facility: Hospitalet de Llobregat Clinical Site 251
city: Sevilla
country: Spain
facility: Sevilla Clinical Site 256
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Clinical Site 341
city: Donetsk
country: Ukraine
facility: Donetsk Clinical Site 345
city: Kharkiv
country: Ukraine
facility: Kharkiv Clinical Site 346
city: Kyiv
country: Ukraine
facility: Kyiv Clinical Site 344
city: Lviv
country: Ukraine
facility: Lviv Clinical Site 343
city: Vinnytsya
country: Ukraine
facility: Vinnytsya Clinical Site 342
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References: