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

December 10, 2015 updated by: Elan Pharmaceuticals

A Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Research Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Research Site
      • Montreal, Quebec, Canada, H3A 2B4
        • Research Site
  • United States
    • California
      • Berkeley, California, United States, 94705
        • Research Site
      • Fresno, California, United States, 93710
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Florida
      • Tampa, Florida, United States, 33609
        • Research Site
      • Vero Beach, Florida, United States, 32960
        • Research Site
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Uniontown, Ohio, United States, 44685
        • Research Site
    • Tennessee
      • Cordova, Tennessee, United States, 78258
        • Research Site
      • Knoxville, Tennessee, United States, 37920
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78258
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Research Site

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:

  • 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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

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

March 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (Estimate)

June 15, 2010

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-MS103

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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