NCT01318421

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at P25-P50 for phase_1 multiple-sclerosis

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

March 8, 2011

Last Update Submit

December 10, 2015

Conditions

Multiple Sclerosis

Keywords

Relapsing forms of secondary progressive multiple sclerosis (SPMS)or relapsing-remitting multiple sclerosis (RRMS)

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).

    Safety and tolerability will be assessed by frequency and severity of AEs.

    1 year

Secondary Outcomes (1)

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

    1 year

Study Arms (1)

ELND002

EXPERIMENTAL

ELND002 sc injection

Drug: ELND002

Interventions

ELND002DRUG
ELND002

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subject has no new medical contraindications to continue participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 18, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Last Updated

December 14, 2015

Record last verified: 2015-12