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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01144351
• Other study ID #: ELND002-MS103
• Status: Terminated
• Phase: Phase 1
• First received: June 9, 2010
• Last updated: December 10, 2015
• Start date: March 2010

Study information

• Verified date: December 2015
• Source: Elan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• ELND002

• Placebo

Locations

Country	Name	City	State
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Montreal	Quebec
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Aurora	Colorado
United States	Research Site	Berkeley	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cordova	Tennessee
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Fresno	California
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Newport Beach	California
United States	Research Site	Northbrook	Illinois
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	Tampa	Florida
United States	Research Site	Uniontown	Ohio
United States	Research Site	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Elan Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		12 weeks	Yes
Secondary	Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)	Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.	12 weeks	No
Secondary	Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions		12 weeks	No
Secondary	Reduction in rate of clinical relapses.		12 weeks	No