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

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: ONO-4641; Drug: ONO-4641 placebo

• Registration Number: NCT01081782
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-11
• Disposition First Submitted: 2013-11-30
• Disposition First Submitted QC: 2013-11-30
• Last Update Submitted: 2013-11-30
• Disposition First Posted: 2013-12-25
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E1	ONO-4641	-
E3	ONO-4641	-
P	ONO-4641 placebo	-
E2	ONO-4641	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total volume of Gd-enhanced lesions	26 weeks

Trial Locations

Locations (86)

Tucson Clinical Site 133; 🇺🇸 Tucson, Arizona, United States

Aurora Clinical Site 132; 🇺🇸 Aurora, Colorado, United States

Fort Collins Clinical Site 123; 🇺🇸 Fort Collins, Colorado, United States

Fairfield Clinical Site 110; 🇺🇸 Fairfield, Connecticut, United States

Ormond Beach Clinical Site 129; 🇺🇸 Ormond Beach, Florida, United States

Sarasota Clinical Site 116; 🇺🇸 Sarasota, Florida, United States

Sarasota Clinical Site 117; 🇺🇸 Sarasota, Florida, United States

Northbrook Clinical Site 135; 🇺🇸 Northbrook, Illinois, United States

Fort Wayne Clinical Site 111; 🇺🇸 Fort Wayne, Indiana, United States

Indianapolis Clinical Site 121; 🇺🇸 Indianapolis, Indiana, United States

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