Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)

NCT00509145 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1106

Last updated 2021-11-02

Study results available
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Summary

Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

Conditions

Interventions

DRUG

Laquinimod

Laquinimod 0.6 mg capsule, oral, once daily

OTHER

Placebo

oral, once daily, capsule

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-11-13
Primary Completion
2010-11-08
Completion
2010-11-08

Countries

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

Study Locations

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Entities

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 NCT00509145 on ClinicalTrials.gov