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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
laquinimod 0.3
laquinimod 0.6
Placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Laquinimod 0.3 mg

    Laquinimod 0.6 mg

    Placebo

    Arm Description

    Laquinimod 0.3 mg

    Laquinimod 0.6 mg

    Blinded Placebo

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Relapse rate

    Full Information

    First Posted
    June 26, 2006
    Last Updated
    April 7, 2011
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00349193
    Brief Title
    A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsing Remitting Multiple Sclerosis
    Keywords
    Relapsing Remitting Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    306 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Laquinimod 0.3 mg
    Arm Type
    Active Comparator
    Arm Description
    Laquinimod 0.3 mg
    Arm Title
    Laquinimod 0.6 mg
    Arm Type
    Active Comparator
    Arm Description
    Laquinimod 0.6 mg
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Blinded Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    laquinimod 0.3
    Intervention Description
    laquinimod 0.3mg
    Intervention Type
    Drug
    Intervention Name(s)
    laquinimod 0.6
    Intervention Description
    laquinimod 0.6mg
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Blinded Placebo
    Primary Outcome Measure Information:
    Title
    Reduction of brain lesions in the last 4 months of the study
    Time Frame
    36 weeks
    Secondary Outcome Measure Information:
    Title
    Relapse rate
    Time Frame
    36 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Prof. Giancarlo Comi
    Organizational Affiliation
    Teva Pharmaceutical Industries, Ltd.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18572078
    Citation
    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.
    Results Reference
    derived

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

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