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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.
Merck KGaA
Ono Pharmaceuticals Co. Ltd., Japan
Information provided by (Responsible Party):
EMD Serono Identifier:
First received: October 19, 2010
Last updated: September 6, 2013
Last verified: September 2013

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


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

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 identifier: NCT01226745

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Sponsors and Collaborators
EMD Serono
Merck KGaA
Ono Pharmaceuticals Co. Ltd., Japan
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 Identifier: NCT01226745     History of Changes
Other Study ID Numbers: ONO-4641POU007 (EMR200559-002), 2010-018705-11
Study First Received: October 19, 2010
Last Updated: September 6, 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
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 processed this record on April 17, 2014