CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,331 enrolled
Drug / intervention
Laquinimod +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/NCT00605215
NCT00605215Phase 3Completed

A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon β-1a (Avonex®) in a Rater-blinded Design

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jan 30, 2008·Updated Apr 21, 2022

In Brief

A Phase 3 clinical trial evaluating Laquinimod, Placebo, and 1 other intervention for Multiple Sclerosis. Completed, enrolled 1,331 participants across 170 sites in 19 countries.

Detailed Summary

The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Croatia, Czechia, Estonia, Georgia, Germany, Israel, Italy, Lithuania, North Macedonia, Poland, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2008
Enrollment StartApr 24, 2008
Primary CompletionJun 10, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 18.4 years ago

Interventions

Laquinimoddrug

Laquinimod will be administered per dose and schedule specified in the arm description.

Placebodrug

Placebo matching to laquinimod will be administered per schedule specified in the arm description.

Avonex®drug

Avonex® will be administered per dose and schedule specified in the arm description.