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

A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01081782

Acronym

DreaMS

Enrollment

407

Registered

2010-03-05

Start date

2010-03-31

Completion date

2011-12-31

Last updated

2013-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, ONO-4641

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.

Interventions

DRUGONO-4641

0.15 mg once per day for 26 weeks

DRUGONO-4641 placebo

Placebo once per day for 26 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.	26 weeks

Secondary

Measure	Time frame
Total volume of Gd-enhanced lesions	26 weeks

Countries

Belgium, Canada, Czechia, Germany, Greece, Japan, Poland, Russia, Spain, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026