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

December 10, 2015 updated by: Elan Pharmaceuticals

An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ELND002
ELND002 sc injection
Drug: ELND002

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elan Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 18, 2011

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELND002-MS153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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