A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).

Key facts

Study ID

NCT01144351

Run by

Elan Pharmaceuticals

People needed

32

Starts

2010-03-01

Last updated by the study team

2015-12-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has either clinically definite or laboratory-supported definite relapsing forms of MS for at least 2 years
• Patients with SPMS or RRMS have documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year
• Has had an inadequate response or intolerability to interferon and/or glatiramer acetate
• Is able and willing to undergo Gd administration and repeat MRI testing

You may not qualify if…

• Has primary progressive MS (PPMS)
• Any history of treatment with recombinant humanized monoclonal antibodies
• Has received treatment with immunosuppressant medications or experimental agents within 3 months prior to the Baseline
• A history of opportunistic infection or the presence of any active infection within 3 months prior to Baseline
• Any history of congestive heart failure or currently has a pacemaker
• Has a known or suspected hypersensitivity to sulfonamides or any of the components of the investigational drug
• Has any medical history or psychiatric condition that would impact outcome or study participation
• Has other clinically significant abnormality on physical, neurological, laboratory, or ECG examination as listed in the protocol during the Screening Phase

Where it is running

• Research Site — Berkeley, California, United States
• Research Site — Fresno, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Tampa, Florida, United States
• Research Site — Vero Beach, Florida, United States
• Research Site — Northbrook, Illinois, United States
• Research Site — Farmington Hills, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Uniontown, Ohio, United States
• Research Site — Cordova, Tennessee, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Salt Lake City, Utah, United States
• Research Site — Calgary, Alberta, Canada
• Research Site — Greenfield Park, Quebec, Canada
• Research Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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