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

Elan Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Multiple Sclerosis

Treatments

Drug: ELND002

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01144351

ELND002-MS103

Details and patient eligibility

About

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).

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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