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

Phase 1TerminatedNCT01318421

Elan Pharmaceuticals12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

ELND002DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).

Safety and tolerability will be assessed by frequency and severity of AEs.

Time frame: 1 year

Secondary Outcomes

To evaluate the PK/PD/BM measurement of ELND002 in patients with MS.

Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.

Time frame: 1 year

Data from ClinicalTrials.gov

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