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OpenTrials
Completed

NCT Number: NCT00349193

A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod

Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions.

The duration of the current study is 36 weeks.

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to give written informed consent
  • Confirmed MS diagnosis as defined by the McDonald criteria
  • R-R MS disease course.
  • At least one gadolinium-enhanced lesion on screening MRI
  • Women of child-bearing potential must practice a reliable method of birth control.
  • Must understand the requirements of the study and agree to comply with the study protocol.

Exclusion criteria

  • Subjects who suffer from any form of progressive MS.
  • Any condition which the investigator feels may interfere with participation in the study.
  • Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
  • Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
  • Previous treatment with immunomodulators within two months prior to screening

Treatment and study plan

laquinimod 0.3

Drug

laquinimod 0.3mg

laquinimod 0.6

Drug

laquinimod 0.6mg

Placebo

Other

Blinded Placebo

Primary outcomes

  1. Reduction of brain lesions in the last 4 months of the study

    Time frame: 36 weeks

Secondary outcomes

  1. Relapse rate

    Time frame: 36 weeks

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 6, 2006
Registry last updated
Apr 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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