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NCT01318421 Clinical Trial

A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:
An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01318421
Other study ID # ELND002-MS153
Secondary ID
Status Terminated
Phase Phase 1
First received March 8, 2011
Last updated December 10, 2015
Start date December 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 evaluate the long-term safety and tolerability of ELND002 in patients with multiple sclerosis (MS) after participation in study MS103.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ELND002

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Elan Pharmaceuticals

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). Safety and tolerability will be assessed by frequency and severity of AEs. 1 year Yes
Secondary 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. 1 year Yes
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