Status:
TERMINATED
A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
Lead Sponsor:
Elan Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 scl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01144351
Start Date
March 1 2010
Last Update
December 14 2015
Active Locations (20)
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1
Research Site
Berkeley, California, United States, 94705
2
Research Site
Fresno, California, United States, 93710
3
Research Site
Newport Beach, California, United States, 92663
4
Research Site
Aurora, Colorado, United States, 80045