A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis - Full Text View

Purpose

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).

Condition	Intervention	Phase
Multiple Sclerosis	Drug: ELND002 Drug: Placebo	Phase 1

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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.
Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Reduction in rate of clinical relapses. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	March 2010
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ELND002 ELND002 sc injection	Drug: ELND002
Placebo Comparator: Placebo placebo injection	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144351

Locations

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

Sponsors and Collaborators

Elan Pharmaceuticals

More Information

No publications provided

Responsible Party:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01144351 History of Changes
Other Study ID Numbers:	ELND002-MS103
Study First Received:	June 9, 2010
Last Updated:	April 12, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:

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

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013