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A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course

NCT00988052 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 839

Last updated 2021-12-09

Study results available
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Summary

The purpose of this study is to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.

Conditions

Interventions

DRUG

Laquinimod

One capsule containing 0.6 mg laquinimod to be administered orally once daily.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Giancarlo Comi, Prof., MD · U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-11-10
Primary Completion
2017-07-01
Completion
2017-07-01
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00988052 on ClinicalTrials.gov