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

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ClinicalTrials.gov Identifier: NCT01318421
Recruitment Status : Terminated
First Posted : March 18, 2011
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Elan Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: ELND002 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
Study Start Date : December 2010
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ELND002
ELND002 sc injection
Drug: ELND002



Primary Outcome Measures :
  1. To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT). [ Time Frame: 1 year ]
    Safety and tolerability will be assessed by frequency and severity of AEs.


Secondary Outcome Measures :
  1. To evaluate the PK/PD/BM measurement of ELND002 in patients with MS. [ Time Frame: 1 year ]
    Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01318421     History of Changes
Other Study ID Numbers: ELND002-MS153
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Elan Pharmaceuticals:
Relapsing forms of secondary progressive multiple sclerosis (SPMS)or relapsing-remitting multiple sclerosis (RRMS)

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases