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

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ClinicalTrials.gov Identifier: NCT00349193
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : April 8, 2011
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

June 26, 2006
July 6, 2006
April 8, 2011
March 2005
June 2006   (Final data collection date for primary outcome measure)
Reduction of brain lesions in the last 4 months of the study [ Time Frame: 36 weeks ]
Reduction of brain lesions in the last 4 months of the study
Complete list of historical versions of study NCT00349193 on ClinicalTrials.gov Archive Site
Relapse rate [ Time Frame: 36 weeks ]
Relapse rate
Not Provided
Not Provided
 
A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing Remitting Multiple Sclerosis
  • Drug: laquinimod 0.3
    laquinimod 0.3mg
  • Drug: laquinimod 0.6
    laquinimod 0.6mg
  • Other: Placebo
    Blinded Placebo
  • Active Comparator: Laquinimod 0.3 mg
    Laquinimod 0.3 mg
    Intervention: Drug: laquinimod 0.3
  • Active Comparator: Laquinimod 0.6 mg
    Laquinimod 0.6 mg
    Intervention: Drug: laquinimod 0.6
  • Placebo Comparator: Placebo
    Blinded Placebo
    Intervention: Other: Placebo
Comi G, Pulizzi A, Rovaris M, Abramsky O, Arbizu T, Boiko A, Gold R, Havrdova E, Komoly S, Selmaj K, Sharrack B, Filippi M; LAQ/5062 Study Group. Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet. 2008 Jun 21;371(9630):2085-92. doi: 10.1016/S0140-6736(08)60918-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
264
August 2006
June 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subjects who suffer from any form of progressive MS.
  2. Any condition which the investigator feels may interfere with participation in the study.
  3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
  4. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
  5. Previous treatment with immunomodulators within two months prior to screening
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Italy
 
NCT00349193
LAQ/5062
2004-003943-28 ( EudraCT Number )
No
Not Provided
Not Provided
Ekkehard Baader, MD, Teva Pharmaceutical Europe B.V.
Teva Pharmaceutical Industries
Not Provided
Study Chair: Prof. Giancarlo Comi Teva Pharmaceutical Industries, Ltd.
Teva Pharmaceutical Industries
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP