Clinical trial NCT01144351: A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: MS
SPMS
RRMS
Relapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS)
or Relapsing-Remitting Multiple Sclerosis (RRMS)
Lead sponsor: Elan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-06-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: 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).
timeFrame: 12 weeks
Secondary outcomes:
measure: Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)
timeFrame: 12 weeks
measure: Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions
timeFrame: 12 weeks
measure: Reduction in rate of clinical relapses.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Research Site
state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Vero Beach
country: United States
facility: Research Site
state: Florida
city: Northbrook
country: United States
facility: Research Site
state: Illinois
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Uniontown
country: United States
facility: Research Site
state: Ohio
city: Cordova
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
Study officials:
References: