Back to resultsA Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ELND002
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Relapsing forms of secondary progressive multiple sclerosis (SPMS)or relapsing-remitting multiple sclerosis (RRMS)
Eligibility Criteria
Inclusion Criteria:
- This study is open only to subjects who have completed the week 12 visit in study ELND002-MS103 while taking their assigned dose of study drug.
Exclusion Criteria:
- Subject has no new medical contraindications to continue participation in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ELND002
Arm Description
ELND002 sc injection
Outcomes
Primary Outcome Measures
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).
Safety and tolerability will be assessed by frequency and severity of AEs.
Secondary Outcome Measures
To evaluate the PK/PD/BM measurement of ELND002 in patients with MS.
Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01318421
Brief Title
A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
Official Title
An Open-Label, Long-Term, Follow-Up Study 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
December 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in patients with multiple sclerosis (MS) after participation in study MS103.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ELND002
Arm Type
Experimental
Arm Description
ELND002 sc injection
Intervention Type
Drug
Intervention Name(s)
ELND002
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).
Description
Safety and tolerability will be assessed by frequency and severity of AEs.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate the PK/PD/BM measurement of ELND002 in patients with MS.
Description
Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.
Time Frame
1 year
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:
This study is open only to subjects who have completed the week 12 visit in study ELND002-MS103 while taking their assigned dose of study drug.
Exclusion Criteria:
Subject has no new medical contraindications to continue participation in the study.
12. IPD Sharing Statement
Learn more about this trial
A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
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