NCT02284568

A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo

A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 study is intended to serve as a proof of concept for potential treatment with laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod in this population.

Detailed description

Due to serious cardiovascular adverse events, Data Monitoring Committee (DMC) made a recommendation to stop all laquinimod treatment arms above 0.6 mg in the multiple sclerosis (MS) trials; therefore the 1.5 mg treatment arm in the ARPEGGIO study was discontinued as of 01 January 2016. The DMC did not identify any definite cardiovascular risk in the 0.6 mg treatment arm, but felt that long term monitoring for emergence of any potential signal was necessary. Therefore, the 0.6 mg treatment arm was continued while the sponsor closely monitored cardiovascular events in all laquinimod studies. Prior to 01 January 2016, eligible patients were randomized in a 1:1:1 ratio into 1 of the following treatment arms (a total of 286 patients were randomized 1:1:1 prior to 01 January 2016): * Laquinimod 0.6 mg daily * Laquinimod 1.5 mg daily * Daily placebo As of 01 January 2016, following the decision to discontinue the laquinimod 1.5 mg dose arm, additional eligible patients (87 patients) who were enrolled were randomized in a 1:1 ratio into one of the following treatment arms: * Laquinimod 0.6 mg daily * Daily placebo

Conditions

• Primary Progressive Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	Laquinimod	Laquinimod capsules in 0.5 mg and 0.6 mg strengths
DRUG	Placebo	Placebo capsules

Timeline

• Start date: 2015-01-12
• Primary completion: 2017-05-04
• Completion: 2017-10-01
• First posted: 2014-11-06
• Last updated: 2022-03-10
• Results posted: 2018-11-02

Locations

99 sites across 10 countries: United States, Canada, Germany, Italy, Netherlands, Poland, Russia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study