A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

Phase 1

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: ELND002

• Registration Number: NCT01318421
• Lead Sponsor: Elan Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in patients with multiple sclerosis (MS) after participation in study MS103.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-18
• 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: 12

Inclusion Criteria

• This study is open only to subjects who have completed the week 12 visit in study ELND002-MS103 while taking their assigned dose of study drug.

Exclusion Criteria

• Subject has no new medical contraindications to continue participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELND002	ELND002	ELND002 sc injection

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).	1 year	Safety and tolerability will be assessed by frequency and severity of AEs.

Secondary Outcome Measures

Name	Time	Method
To evaluate the PK/PD/BM measurement of ELND002 in patients with MS.	1 year	Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.