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Trial record 1 of 2 for:    ONO-4641
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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.
Sponsor:
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
History of Changes
  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:

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

  Show 70 Study Locations
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 19, 2013