A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01318421|
Recruitment Status : Terminated
First Posted : March 18, 2011
Last Update Posted : December 14, 2015
Information provided by (Responsible Party):
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)|
|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|
ELND002 sc injection
Primary Outcome Measures :
- 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 :
- 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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