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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Laquinimod 0.3 mg

Group Type ACTIVE_COMPARATOR

laquinimod 0.3

Intervention Type DRUG

laquinimod 0.3mg

Laquinimod 0.6 mg

Group Type ACTIVE_COMPARATOR

laquinimod 0.6

Intervention Type DRUG

laquinimod 0.6mg

Placebo

Blinded Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Blinded Placebo

Interventions

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laquinimod 0.3

laquinimod 0.3mg

Intervention Type DRUG

laquinimod 0.6

laquinimod 0.6mg

Intervention Type DRUG

Placebo

Blinded Placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No