A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis (DreaMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck KGaA
Ono Pharmaceuticals Co. Ltd., Japan
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01226745
First received: October 19, 2010
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in patients with relapsing-remitting multiple sclerosis (RRMS) in patients who have completed an initial 26-week study (ONO-4641POU006).


Condition Intervention Phase
Multiple Sclerosis
Drug: ONO-4641 (MSC2430913A)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • The long-term safety and tolerability of ONO-4641 (MSC2430913A) using vital signs, pulmonary function tests, ECGs, dermatological and ophthalmologic examinations [ Time Frame: 229 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The number of Gd-enhanced lesions obtained by MRI [ Time Frame: 229 weeks ] [ Designated as safety issue: Yes ]
  • Lesion volume obtained by MRI [ Time Frame: 229 weeks ] [ Designated as safety issue: Yes ]
  • Brain volume obtained by MRI [ Time Frame: 229 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 343
Study Start Date: October 2010
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E1 Drug: ONO-4641 (MSC2430913A)
0.15 mg once per day for 225 weeks
Experimental: E2 Drug: ONO-4641 (MSC2430913A)
0.1 mg once per day for 225 weeks
Experimental: E3 Drug: ONO-4641 (MSC2430913A)
0.05 mg once per day for 225 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed 26 weeks of double-blind phase of Study ONO-4641POU006.

Exclusion Criteria:

  • Presence of any dermatological abnormalities during Study ONO-4641POU006 that could increase the risk of the patient developing a skin cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226745

  Hide Study Locations
Locations
United States, Arizona
Tucson Clinical Site 133
Tucson, Arizona, United States, 85705
United States, Colorado
Aurora Clinical Site 132
Aurora, Colorado, United States, 80045
Fort Collins Clinical Site 123
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Fairfield Clincial Site 110
Fairfield, Connecticut, United States, 06824
United States, Florida
Ormond Beach Clinical Site 129
Ormond Beach, Florida, United States, 32174
Sarasota Clinical Site 116
Sarasota, Florida, United States, 34243
United States, Illinois
Northbrook Clinical Site 135
Northbrook, Illinois, United States, 60062
United States, Indiana
Fort Wayne Clinical Site 111
Fort Wayne, Indiana, United States, 46805
Indianapolis Clinical Site 121
Indianapolis, Indiana, United States, 46202
United States, Michigan
Detroit Clinical Site 104
Detroit, Michigan, United States, 48202
Farmington Hills Clinical Site 126
Farmington Hills, Michigan, United States, 48334
United States, New Hampshire
Lebanon Clinical Site 115
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
Albuquerque Clinical Site 106
Albuquerque, New Mexico, United States, 87131
United States, New York
Rochester Clinical Site 108
Rochester, New York, United States, 14642
United States, North Carolina
Charlotte Clinical Site 125
Charlotte, North Carolina, United States, 28201
Raleigh Clinical Site 103
Raleigh, North Carolina, United States, 27607
United States, Ohio
Akron Clinical Site 112
Akron, Ohio, United States, 44320
United States, Pennsylvania
Philadelphia Clinical Site 120
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Knoxville Clinical Site 134
Knoxville, Tennessee, United States, 37934
United States, Texas
Round Rock Clinical Site 107
Round Rock, Texas, United States, 78681
Belgium
Brugge Clinical Site 203
Brugge, Belgium, 8000
La Louviere Clinical Site 201
La Louviere, Belgium, 8000
Canada, British Columbia
Vancouver Clinical Site 131
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Quebec
Gatineau Clinical Site 114
Gatineau, Quebec, Canada
Greenfield park Clinical Site 109
Greenfield Park, Quebec, Canada, J4V2J2
Montreal Clinical Site 101
Montreal, Quebec, Canada, H1T2M4
Canada
Montreal Clinical Site 102
Montreal, Canada, H9X3Z9
Czech Republic
Olomouc Clinical Site 212
Olomouc, Czech Republic, 775 20
Pardubice Clinical Site 211
Pardubice, Czech Republic, 53203
Praha 5 Clinical Site 213
Praha 5, Czech Republic, 15006
Germany
Glessen Clinical Site 221
Glessen, Germany, 35385
Leipzig Clinical Site 229
Leipzig, Germany, 04103
Marburg Clinical Site 228
Marburg, Germany, 35033
Tubingen Clinical Site 226
Tubingen, Germany, 72076
Greece
Athens Clinical Site 243
Athens, Greece, 115 29
Japan
Kanto Region Clinical Site 405
Kanto, Japan
Kanto Region Clinical Site 404
Kanto, Japan
Kanto Region Clinical Site 409
Kanto, Japan
Kanto Region Clinical Site 406
Kanto, Japan
Kinki Region Clinical Site 408
Kinki, Japan
Kinki Region Clinical Site 407
Kinki, Japan
Kinki Region Clinical Site 401
Kinki, Japan
Tohoku Region Clinical Site 410
Tohoku, Japan
Tohoku Region Clinical Site 403
Tohoku, Japan
Poland
Bialystok Clinical Site 305
Bialystok, Poland, 15-402
Czeladz Clinical Site 303
Czeladz, Poland, 41-250
Gdansk Clinical Site 302
Gdansk, Poland, 80-803
Katowice Clinical Site 309
Katowice, Poland, 40-594
Krakow Clinical Site 307
Krakow, Poland, 31-530
Lodz Clinical Site 306
Lodz, Poland, 90-153
Plewiska Clinical Site 304
Plewiska, Poland, 62-064
Warszawa Clinical Site 308
Warszawa, Poland, 04-749
Russian Federation
Kazan Clinical Site 333
Kazan, Russian Federation, 420103
Moscow Clinical Site 332
Moscow, Russian Federation, 107150
Moscow Clinical Site 330
Moscow, Russian Federation, 121356
Nizhniy Novgorod Clinical Site 321
Nizhniy Novgorod, Russian Federation, 107150
Novosibirsk Clinical Site 324
Novosibirsk, Russian Federation, 630091
Samara Clinical Site 329
Samara, Russian Federation, 443095
St. Petersburg Clinical Site 325
St. Petersburg, Russian Federation, 194354
Ufa Clinical Site 326
Ufa, Russian Federation, 450005
Spain
Barcelona Clinical Site 253
Barcelona, Spain, 08025
Barcelona Clinical Site 252
Barcelona, Spain, 08025
Bilbao Clinical Site 255
Bilbao, Spain, 48013
Girona Clinical Site 254
Girona, Spain, 17007
Hospitalet de Llobregat Clinical Site 251
Hospitalet de Llobregat, Spain, 08907
Sevilla Clinical Site 256
Sevilla, Spain, 41071
Ukraine
Dnipropetrovsk Clinical Site 341
Dnipropetrovsk, Ukraine, 49027
Kyiv Clinical Site 344
Kyiv, Ukraine, 03110
Lviv Clinical Site 343
Lviv, Ukraine, 03110
Vinnytsya Clinical Site 342
Vinnytsya, Ukraine, 21005
Sponsors and Collaborators
EMD Serono
Merck KGaA
Ono Pharmaceuticals Co. Ltd., Japan
Investigators
Study Director: Medical Responsible EMD Serono, Inc.
Study Director: Study Director Ono Pharmaceuticals Co. Ltd., Japan
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01226745     History of Changes
Other Study ID Numbers: ONO-4641POU007 (EMR200559-002), 2010-018705-11
Study First Received: October 19, 2010
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Spain: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

Keywords provided by EMD Serono:
Multiple sclerosis, ONO-4641 (MSC2430913A)

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014