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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01081782
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis Drug: ONO-4641 Drug: ONO-4641 placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks. [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Total volume of Gd-enhanced lesions [ Time Frame: 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081782


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Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd

Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT01081782     History of Changes
Other Study ID Numbers: ONO-4641POU006
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: November 2013

Keywords provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):
Multiple Sclerosis
ONO-4641

Additional relevant MeSH terms:
Sclerosis
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