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:
EMD Serono
Collaborators:
Merck Serono S.A., Genenva, Switzerland
Ono Pharmaceuticals Co. Ltd., Japan
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01226745
First received: October 19, 2010
Last updated: February 7, 2013
Last verified: February 2013
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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: 122 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The number of Gd-enhanced lesions obtained by MRI [ Time Frame: 122 weeks ] [ Designated as safety issue: Yes ]
- Lesion volume obtained by MRI [ Time Frame: 122 weeks ] [ Designated as safety issue: Yes ]
- Brain volume obtained by MRI [ Time Frame: 122 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 376 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: E1 |
Drug: ONO-4641 (MSC2430913A)
0.15 mg once per day for 122 weeks
|
| Experimental: E2 |
Drug: ONO-4641 (MSC2430913A)
0.1 mg once per day for 122 weeks
|
| Experimental: E3 |
Drug: ONO-4641 (MSC2430913A)
0.05 mg once per day for 122 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226745
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| 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 404 | |
| Kanto, Japan | |
| Kanto Region Clinical Site 406 | |
| Kanto, Japan | |
| Kanto Region Clinical Site 405 | |
| 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 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 330 | |
| Moscow, Russian Federation, 121356 | |
| Moscow Clinical Site 332 | |
| Moscow, Russian Federation, 107150 | |
| 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 252 | |
| Barcelona, Spain, 08025 | |
| Barcelona Clinical Site 253 | |
| 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 Serono S.A., Genenva, Switzerland
Ono Pharmaceuticals Co. Ltd., Japan
Investigators
| Study Director: | Bettina Stubinsky, MD | 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: | February 7, 2013 |
| 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 Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013