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

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ELND002
Placebo
Sponsored by
Elan Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS, SPMS, RRMS, Relapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS), or Relapsing-Remitting Multiple Sclerosis (RRMS)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ELND002

Placebo

Arm Description

ELND002 sc injection

placebo injection

Outcomes

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).

Secondary Outcome Measures

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.
Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions
Reduction in rate of clinical relapses.

Full Information

First Posted
June 9, 2010
Last Updated
December 10, 2015
Sponsor
Elan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01144351
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elan Pharmaceuticals

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
MS, SPMS, RRMS, Relapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS), or Relapsing-Remitting Multiple Sclerosis (RRMS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ELND002
Arm Type
Experimental
Arm Description
ELND002 sc injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo injection
Intervention Type
Drug
Intervention Name(s)
ELND002
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)
Description
Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.
Time Frame
12 weeks
Title
Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions
Time Frame
12 weeks
Title
Reduction in rate of clinical relapses.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Research Site
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Research Site
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Research Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Research Site
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Research Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Site
City
Uniontown
State/Province
Ohio
ZIP/Postal Code
44685
Country
United States
Facility Name
Research Site
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
78258
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Research Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada

12. IPD Sharing Statement

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

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