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Clinical Trials/NCT01318421
NCT01318421TerminatedPhase 1

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

Elan Pharmaceuticals0 sites12 target enrollmentStarted: December 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
12
Primary Endpoint
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

ELND002

Experimental

ELND002 sc injection

Intervention: ELND002 (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • To evaluate the PK/PD/BM measurement of ELND002 in patients with MS.(1 year)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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