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

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT01081782

Run by

Ono Pharma USA Inc

People needed

407

Starts

2010-03-01

Expected to finish

2011-12-01

Last updated by the study team

2013-12-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male or female aged 18-55 years inclusive at screening
• Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis

You may not qualify if…

• 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)

Where it is running

• 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
• Detroit Clinical Site 104 — Detroit, Michigan, United States
• Farmington Hills Clinical Site 126 — Farmington Hills, Michigan, United States
• Lebanon Clinical Site 115 — Lebanon, New Hampshire, United States
• Albuquerque Clinical Site 106 — Albuquerque, New Mexico, United States
• Rochester Clinical Site 108 — Rochester, New York, United States
• Charlotte Clinical Site 125 — Charlotte, North Carolina, United States
• HighPoint Clinical Site 128 — HighPoint, North Carolina, United States
• Raleigh Clinical Site 103 — Raleigh, North Carolina, United States
• Akron Clinical Site 112 — Akron, Ohio, United States
• Philadelphia Clinical Site 120 — Philadelphia, Pennsylvania, United States
• Knoxville Clinical Site 134 — Knoxville, Tennessee, United States
• Round Rock Clinical Site 107 — Round Rock, Texas, United States
• Seattle Clinical Site 118 — Seattle, Washington, United States
• Brugge Clinical Site 203 — Bruges, Belgium
• La Louviere Clinical Site 201 — La Louvière, Belgium
• Tucson Clinical Site 133 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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