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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ONO-4641
ONO-4641
ONO-4641
ONO-4641 placebo
Sponsored by
Ono Pharma USA Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, ONO-4641

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Tucson Clinical Site 133
  • Aurora Clinical Site 132
  • Fort Collins Clinical Site 123
  • Fairfield Clinical Site 110
  • Ormond Beach Clinical Site 129
  • Sarasota Clinical Site 116
  • Sarasota Clinical Site 117
  • Northbrook Clinical Site 135
  • Fort Wayne Clinical Site 111
  • Indianapolis Clinical Site 121
  • Detroit Clinical Site 104
  • Farmington Hills Clinical Site 126
  • Lebanon Clinical Site 115
  • Albuquerque Clinical Site 106
  • Rochester Clinical Site 108
  • Charlotte Clinical Site 125
  • HighPoint Clinical Site 128
  • Raleigh Clinical Site 103
  • Akron Clinical Site 112
  • Philadelphia Clinical Site 120
  • Knoxville Clinical Site 134
  • Round Rock Clinical Site 107
  • Seattle Clinical Site 118
  • Brugge Clinical Site 203
  • La Louviere Clinical Site 201
  • Sijsele Clinical Site 202
  • Gatineau Clinical Site 114
  • Greenfield Park Clinical Site 109
  • Vancouver Clinical Site 131
  • Montreal Clinical Site 113
  • Montreal Clinical Site 102
  • Olomouc Clinical Site 212
  • Ostrava Clinical Site 214
  • Pardubice Clinical Site 211
  • Praha 5 Clinical Site 213
  • Berlin Clinical Site 223
  • Essen Clinical Site 222
  • Giessen Clinical Site 221
  • Leipzig Clinical Site 229
  • Mainz Clinical Site 231
  • Marburg Clinical Site 228
  • Munster Clinical Site 225
  • Tubingen Clinical Site 226
  • Ulm Clinical Site 230
  • Athens Clinical Site 243
  • Thessaloniki Clinical Site 245
  • Kanto Region Clinical Site 404
  • Kanto Region Clinical Site 405
  • Kanto Region Clinical Site 406
  • Kanto Region Clinical Site 409
  • Kinki Region Clinical Site 401
  • Kinki Region Clinical Site 407
  • Kinki Region Clinical Site 408
  • Tohoku Region Clinical Site 403
  • Tohoku Region Clinical Site 410
  • Bialystok Clinical Site 305
  • Czeladz Clinical Site 303
  • Gdansk Clinical Site 302
  • Katowice Clinical Site 309
  • Krakow Clinical Site 307
  • Lodz Clinical Site 306
  • Plewiska Clinical Site 304
  • Warszawa Clinical Site 308
  • Chelyabinsk Clinical Site 322
  • Kaluga Clinical Site 328
  • Kazan Clinical Site 333
  • Moscow Clinical Site 332
  • Nizhniy Novgorod Clinical Site 321
  • Novosibirsk Clinical Site 324
  • Samara Clinical Site 328
  • St. Petersburg Clinical Site 325
  • St. Petersburg Clinical Site 327
  • Ufa Clinical Site 326
  • Yaroslavl Clinical Site 331
  • Barcelona Clinical Site 252
  • Barcelona Clinical Site 253
  • Bilbao Clinical Site 255
  • Girona Clinical Site 254
  • Hospitalet de Llobregat Clinical Site 251
  • Sevilla Clinical Site 256
  • Dnipropetrovsk Clinical Site 341
  • Donetsk Clinical Site 345
  • Kharkiv Clinical Site 346
  • Kyiv Clinical Site 344
  • Lviv Clinical Site 343
  • Vinnytsya Clinical Site 342

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

E1

E2

E3

P

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total volume of Gd-enhanced lesions

Full Information

First Posted
March 4, 2010
Last Updated
November 30, 2013
Sponsor
Ono Pharma USA Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01081782
Brief Title
A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
Acronym
DreaMS
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, ONO-4641

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E1
Arm Type
Experimental
Arm Title
E2
Arm Type
Experimental
Arm Title
E3
Arm Type
Experimental
Arm Title
P
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ONO-4641
Intervention Description
0.15 mg once per day for 26 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-4641
Intervention Description
0.1 mg once per day for 26 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-4641
Intervention Description
0.05 mg once per day for 26 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-4641 placebo
Intervention Description
Placebo once per day for 26 weeks
Primary Outcome Measure Information:
Title
Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Total volume of Gd-enhanced lesions
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Pharma USA, Inc.
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Tucson Clinical Site 133
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Aurora Clinical Site 132
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Fort Collins Clinical Site 123
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Fairfield Clinical Site 110
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Ormond Beach Clinical Site 129
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Sarasota Clinical Site 116
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Sarasota Clinical Site 117
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Northbrook Clinical Site 135
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Fort Wayne Clinical Site 111
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Indianapolis Clinical Site 121
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Detroit Clinical Site 104
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Farmington Hills Clinical Site 126
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Lebanon Clinical Site 115
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albuquerque Clinical Site 106
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Rochester Clinical Site 108
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Charlotte Clinical Site 125
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
HighPoint Clinical Site 128
City
HighPoint
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States
Facility Name
Raleigh Clinical Site 103
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Akron Clinical Site 112
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
Philadelphia Clinical Site 120
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Knoxville Clinical Site 134
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Round Rock Clinical Site 107
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Seattle Clinical Site 118
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Brugge Clinical Site 203
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
La Louviere Clinical Site 201
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Sijsele Clinical Site 202
City
Sijsele
ZIP/Postal Code
8340
Country
Belgium
Facility Name
Gatineau Clinical Site 114
City
Gatineau
State/Province
Quebec
Country
Canada
Facility Name
Greenfield Park Clinical Site 109
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V2J2
Country
Canada
Facility Name
Vancouver Clinical Site 131
City
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Montreal Clinical Site 113
City
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Montreal Clinical Site 102
City
Quebec
ZIP/Postal Code
H9X 3Z9
Country
Canada
Facility Name
Olomouc Clinical Site 212
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Ostrava Clinical Site 214
City
Ostrava
ZIP/Postal Code
702 00
Country
Czech Republic
Facility Name
Pardubice Clinical Site 211
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
Facility Name
Praha 5 Clinical Site 213
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Berlin Clinical Site 223
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Essen Clinical Site 222
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Giessen Clinical Site 221
City
Giessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Leipzig Clinical Site 229
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Mainz Clinical Site 231
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Marburg Clinical Site 228
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
Munster Clinical Site 225
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Tubingen Clinical Site 226
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Ulm Clinical Site 230
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Athens Clinical Site 243
City
Athens
ZIP/Postal Code
11529
Country
Greece
Facility Name
Thessaloniki Clinical Site 245
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Kanto Region Clinical Site 404
City
Kanto
Country
Japan
Facility Name
Kanto Region Clinical Site 405
City
Kanto
Country
Japan
Facility Name
Kanto Region Clinical Site 406
City
Kanto
Country
Japan
Facility Name
Kanto Region Clinical Site 409
City
Kanto
Country
Japan
Facility Name
Kinki Region Clinical Site 401
City
Kinki
Country
Japan
Facility Name
Kinki Region Clinical Site 407
City
Kinki
Country
Japan
Facility Name
Kinki Region Clinical Site 408
City
Kinki
Country
Japan
Facility Name
Tohoku Region Clinical Site 403
City
Tohoku
Country
Japan
Facility Name
Tohoku Region Clinical Site 410
City
Tohoku
Country
Japan
Facility Name
Bialystok Clinical Site 305
City
Bialystok
ZIP/Postal Code
15-402
Country
Poland
Facility Name
Czeladz Clinical Site 303
City
Czeladz
ZIP/Postal Code
41-250
Country
Poland
Facility Name
Gdansk Clinical Site 302
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Katowice Clinical Site 309
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Facility Name
Krakow Clinical Site 307
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Lodz Clinical Site 306
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Plewiska Clinical Site 304
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
Warszawa Clinical Site 308
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Chelyabinsk Clinical Site 322
City
Chelyabinsk
ZIP/Postal Code
454136
Country
Russian Federation
Facility Name
Kaluga Clinical Site 328
City
Kaluga
ZIP/Postal Code
428007
Country
Russian Federation
Facility Name
Kazan Clinical Site 333
City
Kazan
ZIP/Postal Code
420103
Country
Russian Federation
Facility Name
Moscow Clinical Site 332
City
Moscow
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
Nizhniy Novgorod Clinical Site 321
City
Nizhniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Novosibirsk Clinical Site 324
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Samara Clinical Site 328
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
St. Petersburg Clinical Site 325
City
St. Petersburg
ZIP/Postal Code
428007
Country
Russian Federation
Facility Name
St. Petersburg Clinical Site 327
City
St. Petersburg
ZIP/Postal Code
428007
Country
Russian Federation
Facility Name
Ufa Clinical Site 326
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Yaroslavl Clinical Site 331
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Barcelona Clinical Site 252
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Barcelona Clinical Site 253
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Bilbao Clinical Site 255
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Girona Clinical Site 254
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospitalet de Llobregat Clinical Site 251
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Sevilla Clinical Site 256
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Dnipropetrovsk Clinical Site 341
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Donetsk Clinical Site 345
City
Donetsk
ZIP/Postal Code
83000-490
Country
Ukraine
Facility Name
Kharkiv Clinical Site 346
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kyiv Clinical Site 344
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Lviv Clinical Site 343
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Vinnytsya Clinical Site 342
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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