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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.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT01081782
First received: March 4, 2010
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081782

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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT01081782     History of Changes
Other Study ID Numbers: ONO-4641POU006
Study First Received: March 4, 2010
Last Updated: June 12, 2012
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
ONO-4641

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 June 18, 2013