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A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT01144351•Elan Pharmaceuticals

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (20)

Research Site

Berkeley, California, United States

Research Site

Fresno, California, United States

Research Site

Newport Beach, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Tampa, Florida, United States

Research Site

Vero Beach, Florida, United States

Research Site

Northbrook, Illinois, United States

Research Site

Farmington Hills, Michigan, United States

Research Site

Minneapolis, Minnesota, United States

Research Site

Albuquerque, New Mexico, United States

Key Dates

Start Date

March 1, 2010

Primary Completion Date

December 1, 2012

Last Updated

December 14, 2015

Enrollment

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

ELND002

DRUG

Placebo

DRUG

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

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