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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00349193
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : April 8, 2011
Sponsor:
Information provided by:
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: laquinimod 0.3 Drug: laquinimod 0.6 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Laquinimod 0.3 mg
Laquinimod 0.3 mg
 Drug: laquinimod 0.3
laquinimod 0.3mg
Active Comparator: Laquinimod 0.6 mg
Laquinimod 0.6 mg
 Drug: laquinimod 0.6
laquinimod 0.6mg
Placebo Comparator: Placebo
Blinded Placebo
 Other: Placebo
Blinded Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of brain lesions in the last 4 months of the study [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. Relapse rate [ Time Frame: 36 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349193


Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Chair: Prof. Giancarlo Comi Teva Pharmaceutical Industries, Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ekkehard Baader, MD, Teva Pharmaceutical Europe B.V.
ClinicalTrials.gov Identifier: NCT00349193    
Other Study ID Numbers: LAQ/5062
2004-003943-28 ( EudraCT Number )
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: April 2011
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
Relapsing Remitting Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases