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An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease

NCT00745615 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2019-03-27

Study results available
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Summary

This is a multinational, multicenter, randomized, double-blind, parallel-group active extension of LAQ/5062 study (NCT00349193), assessing the tolerability, safety and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in participants with relapsing remitting multiple sclerosis (RRMS), followed by an open-label phase of laquinimod 0.6 mg daily. This study is LAQ/5063 (i.e., double-blind extension) and LAQ/5063 OL (i.e., subsequent open-label extension). - The first period of the extension study is an active, double-blind period. Participants from the active treatment arms in LAQ/5062 continue their assigned treatment in blinded fashion. Participants who were assigned to placebo treatment in LAQ/5062 are equally randomized in blinded-fashion to laquinimod 0.6 mg or laquinimod 0.3 mg. - Once termination visit of LAQ/5063 active double-blind phase (completion of the full 36 weeks or as requested by the Sponsor) is performed, all participants continue on laquinimod 0.6 mg daily as an open-label intervention. The open-label period continues as long as the Sponsor continues the development of laquinimod 0.6 mg for RRMS or early discontinuation.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

Laquinimod

Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.

DRUG

Placebo

Placebo matching to laquinimod will be administered as per the dose and schedule specified in the respective arms.

Sponsors & Collaborators

  • Teva Pharmaceutical Industries, Ltd.

    lead INDUSTRY

Principal Investigators

  • Giancarlo Comi · Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-07
Primary Completion
2017-07-23
Completion
2017-07-23
FDA Drug
Yes

Countries

  • Czechia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00745615 on ClinicalTrials.gov