A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis (DreaMS)

November 30, 2013 updated by: Ono Pharma USA Inc

A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

407

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Brugge Clinical Site 203
      • La Louviere, Belgium, 7100
        • La Louviere Clinical Site 201
      • Sijsele, Belgium, 8340
        • Sijsele Clinical Site 202
  • Canada
      • British Columbia, Canada, V6T 2B5
        • Vancouver Clinical Site 131
      • Quebec, Canada, H1T 2M4
        • Montreal Clinical Site 113
      • Quebec, Canada, H9X 3Z9
        • Montreal Clinical Site 102
    • Quebec
      • Gatineau, Quebec, Canada
        • Gatineau Clinical Site 114
      • Greenfield Park, Quebec, Canada, J4V2J2
        • Greenfield park Clinical Site 109
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • Olomouc Clinical Site 212
      • Ostrava, Czech Republic, 702 00
        • Ostrava Clinical Site 214
      • Pardubice, Czech Republic, 532 03
        • Pardubice Clinical Site 211
      • Praha 5, Czech Republic, 150 06
        • Praha 5 Clinical Site 213
  • Germany
      • Berlin, Germany, 13347
        • Berlin Clinical Site 223
      • Essen, Germany, 45147
        • Essen Clinical Site 222
      • Giessen, Germany, 35385
        • Giessen Clinical Site 221
      • Leipzig, Germany, 04103
        • Leipzig Clinical Site 229
      • Mainz, Germany, 55101
        • Mainz Clinical Site 231
      • Marburg, Germany, 35033
        • Marburg Clinical Site 228
      • Munster, Germany, 48149
        • Munster Clinical Site 225
      • Tubingen, Germany, 72076
        • Tubingen Clinical Site 226
      • Ulm, Germany, 89081
        • Ulm Clinical Site 230
  • Greece
      • Athens, Greece, 11529
        • Athens Clinical Site 243
      • Thessaloniki, Greece, 57010
        • Thessaloniki Clinical Site 245
  • Japan
      • Kanto, Japan
        • 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
      • Kinki, Japan
        • Kinki Region Clinical Site 401
      • Kinki, Japan
        • Kinki Region Clinical Site 407
      • Kinki, Japan
        • Kinki Region Clinical Site 408
      • Tohoku, Japan
        • Tohoku Region Clinical Site 403
      • Tohoku, Japan
        • Tohoku Region Clinical Site 410
  • Poland
      • Bialystok, Poland, 15-402
        • Bialystok Clinical Site 305
      • Czeladz, Poland, 41-250
        • Czeladz Clinical Site 303
      • Gdansk, Poland, 80-803
        • Gdansk Clinical Site 302
      • Katowice, Poland, 40-594
        • Katowice Clinical Site 309
      • Krakow, Poland, 31-530
        • Krakow Clinical Site 307
      • Lodz, Poland, 90-153
        • Lodz Clinical Site 306
      • Plewiska, Poland, 62-064
        • Plewiska Clinical Site 304
      • Warszawa, Poland, 04-749
        • Warszawa Clinical Site 308
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454136
        • Chelyabinsk Clinical Site 322
      • Kaluga, Russian Federation, 428007
        • Kaluga Clinical Site 328
      • Kazan, Russian Federation, 420103
        • Kazan Clinical Site 333
      • Moscow, Russian Federation, 107150
        • Moscow Clinical Site 332
      • Nizhniy Novgorod, Russian Federation, 603155
        • Nizhniy Novgorod Clinical Site 321
      • Novosibirsk, Russian Federation, 630091
        • Novosibirsk Clinical Site 324
      • Samara, Russian Federation, 443095
        • Samara Clinical Site 328
      • St. Petersburg, Russian Federation, 428007
        • St. Petersburg Clinical Site 325
      • St. Petersburg, Russian Federation, 428007
        • St. Petersburg Clinical Site 327
      • Ufa, Russian Federation, 450005
        • Ufa Clinical Site 326
      • Yaroslavl, Russian Federation, 150030
        • Yaroslavl Clinical Site 331
  • Spain
      • Barcelona, Spain, 08025
        • Barcelona Clinical Site 252
      • Barcelona, Spain, 08025
        • Barcelona Clinical Site 253
      • Bilbao, Spain, 48013
        • Bilbao Clinical Site 255
      • Girona, Spain, 17007
        • Girona Clinical Site 254
      • Hospitalet de Llobregat, Spain, 08907
        • Hospitalet de Llobregat Clinical Site 251
      • Sevilla, Spain, 41071
        • Sevilla Clinical Site 256
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49027
        • Dnipropetrovsk Clinical Site 341
      • Donetsk, Ukraine, 83000-490
        • Donetsk Clinical Site 345
      • Kharkiv, Ukraine, 61068
        • Kharkiv Clinical Site 346
      • Kyiv, Ukraine, 03110
        • Kyiv Clinical Site 344
      • Lviv, Ukraine, 79010
        • Lviv Clinical Site 343
      • Vinnytsya, Ukraine, 21005
        • Vinnytsya Clinical Site 342
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Tucson Clinical Site 133
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Aurora Clinical Site 132
      • Fort Collins, Colorado, United States, 80528
        • Fort Collins Clinical Site 123
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Fairfield Clinical Site 110
    • Florida
      • Ormond Beach, Florida, United States, 32174
        • Ormond Beach Clinical Site 129
      • Sarasota, Florida, United States, 34243
        • Sarasota Clinical Site 116
      • Sarasota, Florida, United States, 34243
        • Sarasota Clinical Site 117
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Northbrook Clinical Site 135
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Fort Wayne Clinical Site 111
      • Indianapolis, Indiana, United States, 46202
        • Indianapolis Clinical Site 121
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Detroit Clinical Site 104
      • Farmington Hills, Michigan, United States, 48334
        • Farmington Hills Clinical Site 126
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Lebanon Clinical Site 115
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Albuquerque Clinical Site 106
    • New York
      • Rochester, New York, United States, 14642
        • Rochester Clinical Site 108
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Charlotte Clinical Site 125
      • HighPoint, North Carolina, United States, 27265
        • HighPoint Clinical Site 128
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Clinical Site 103
    • Ohio
      • Akron, Ohio, United States, 44320
        • Akron Clinical Site 112
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia Clinical Site 120
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Knoxville Clinical Site 134
    • Texas
      • Round Rock, Texas, United States, 78681
        • Round Rock Clinical Site 107
    • Washington
      • Seattle, Washington, United States, 98101
        • Seattle Clinical Site 118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: P
Drug: ONO-4641 placebo
Placebo once per day for 26 weeks
Experimental: E2
Drug: ONO-4641
0.15 mg once per day for 26 weeks
Drug: ONO-4641
0.1 mg once per day for 26 weeks
Drug: ONO-4641
0.05 mg once per day for 26 weeks
Experimental: E1
Drug: ONO-4641
0.15 mg once per day for 26 weeks
Drug: ONO-4641
0.1 mg once per day for 26 weeks
Drug: ONO-4641
0.05 mg once per day for 26 weeks
Experimental: E3
Drug: ONO-4641
0.15 mg once per day for 26 weeks
Drug: ONO-4641
0.1 mg once per day for 26 weeks
Drug: ONO-4641
0.05 mg once per day for 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Total volume of Gd-enhanced lesions
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharma USA Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (Estimate)

March 5, 2010

Study Record Updates

Last Update Posted (Estimate)

December 25, 2013

Last Update Submitted That Met QC Criteria

November 30, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4641POU006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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