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

Phase 1

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: ELND002; Drug: Placebo

• Registration Number: NCT01144351
• Lead Sponsor: Elan Pharmaceuticals

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 sclerosis (RRMS).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-15
• Primary Completion: 2012-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ELND002	ELND002	ELND002 sc injection
Placebo	Placebo	placebo injection

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS).	12 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)	12 weeks	Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.
Reduction in rate of clinical relapses.	12 weeks
Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions	12 weeks

Trial Locations

Locations (1)

Research Site; 🇨🇦 Montreal, Quebec, Canada