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

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01318421
Enrollment
12
Registered
2011-03-18
Start date
2010-12-31
Completion date
Unknown
Last updated
2015-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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

Elan Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).1 yearSafety and tolerability will be assessed by frequency and severity of AEs.

Secondary

MeasureTime frameDescription
To evaluate the PK/PD/BM measurement of ELND002 in patients with MS.1 yearMeasurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026