CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Avonex (Interferon beta 1a) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00501943
NCT00501943Phase 2Completed

Neuroprotection With Riluzole in Patients With Early Multiple Sclerosis

University of California, San Francisco·interventional·Posted Jul 16, 2007·Updated Apr 9, 2014

In Brief

A Phase 2 clinical trial evaluating Avonex (Interferon beta 1a), Riluzole, and 1 other intervention for Multiple Sclerosis. Completed, enrolled 43 participants across 1 site.

Detailed Summary

This is a double blind, randomized, parallel group design placebo-controlled mono-center study. Patients will be evaluated within twelve months of CIS onset. Patients with at least 2 silent ovoid T2 bright areas in the deep white matter on their clinic brain MRI scan will be offered participation in the study. Patients will be randomized to oral riluzole or placebo (1:1). Patient will take 50 mg of riluzole or placebo once a day for one month. If 50 mg once a day is well tolerated, patients will then go on 50 mg twice daily for the rest of the study. They will start Avonex (Interferon beta 1a) therapy 30 mcg IM once weekly 3 months after study drug (riluzole or placebo) is initiated if their liver function has remained normal. Forty patients within twelve months of onset CIS onset will be enrolled at UCSF MS Center. Patients will be evaluated every month for the first 12 months and every three months thereafter for a total study duration of 24-month. Enrollment period will last six months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 16, 2007
Enrollment StartJul 1, 2006
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 19.0 years ago

Interventions

Avonex (Interferon beta 1a)drug

Riluzoledrug

Placebodrug