Multiple Sclerosis
Conditions
Keywords
Relapsing forms of secondary progressive multiple sclerosis (SPMS)or relapsing-remitting multiple sclerosis (RRMS)
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.
Interventions
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT). | 1 year | Safety and tolerability will be assessed by frequency and severity of AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the PK/PD/BM measurement of ELND002 in patients with MS. | 1 year | Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM. |