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

This study has been completed.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ) Identifier:
First received: March 4, 2010
Last updated: November 30, 2013
Last verified: November 2013
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.

Condition Intervention Phase
Multiple Sclerosis
Drug: ONO-4641
Drug: ONO-4641 placebo
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total volume of Gd-enhanced lesions [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 407
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E1 Drug: ONO-4641
0.15 mg once per day for 26 weeks
Experimental: E2 Drug: ONO-4641
0.1 mg once per day for 26 weeks
Experimental: E3 Drug: ONO-4641
0.05 mg once per day for 26 weeks
Placebo Comparator: P Drug: ONO-4641 placebo
Placebo once per day for 26 weeks


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

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)
  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 identifier: NCT01081782

  Show 86 Study Locations
Sponsors and Collaborators
Ono Pharma USA Inc
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
  More Information

Responsible Party: Ono Pharma USA Inc Identifier: NCT01081782     History of Changes
Other Study ID Numbers: ONO-4641POU006 
Study First Received: March 4, 2010
Last Updated: November 30, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
Japan: Ministry of Health, Labor and Welfare
Greece: National Organization of Medicines
Spain: Ministry of Health
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Ukraine: Ministry of Health
Russia: Ministry of Health of the Russian Federation

Keywords provided by Ono Pharmaceutical Co. Ltd:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on December 02, 2016