MedDataX Logo

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

NCT ID: NCT01144351

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

MS SPMS RRMS Relapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS) or Relapsing-Remitting Multiple Sclerosis (RRMS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ELND002

ELND002 sc injection

Group Type EXPERIMENTAL

ELND002

Intervention Type DRUG

Placebo

placebo injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ELND002

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Elan Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Berkeley, California, United States

Site Status

Research Site

Fresno, California, United States

Site Status

Research Site

Newport Beach, California, United States

Site Status

Research Site

Aurora, Colorado, United States

Site Status

Research Site

Tampa, Florida, United States

Site Status

Research Site

Vero Beach, Florida, United States

Site Status

Research Site

Northbrook, Illinois, United States

Site Status

Research Site

Farmington Hills, Michigan, United States

Site Status

Research Site

Minneapolis, Minnesota, United States

Site Status

Research Site

Albuquerque, New Mexico, United States

Site Status

Research Site

Raleigh, North Carolina, United States

Site Status

Research Site

Cincinnati, Ohio, United States

Site Status

Research Site

Uniontown, Ohio, United States

Site Status

Research Site

Cordova, Tennessee, United States

Site Status

Research Site

Knoxville, Tennessee, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

Salt Lake City, Utah, United States

Site Status

Research Site

Calgary, Alberta, Canada

Site Status

Research Site

Greenfield Park, Quebec, Canada

Site Status

Research Site

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ELND002-MS103

Identifier Type: -

Identifier Source: org_study_id