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

Ono Pharma USA Inc86 sites in 7 countries407 target enrollmentMarch 2010

ConditionsMultiple Sclerosis

InterventionsONO-4641 ONO-4641 placebo

DrugsONO-4641 ONO-4641 placebo

Overview

Phase: Phase 2
Intervention: ONO-4641
Conditions: Multiple Sclerosis
Sponsor: Ono Pharma USA Inc
Enrollment: 407
Locations: 86
Primary Endpoint: Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

December 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ono Pharma USA Inc

Responsible Party

Sponsor

Eligibility 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)