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

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: laquinimod 0.6; Drug: laquinimod 0.3; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00349193

LAQ/5062

2004-003943-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 306 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 3 patient groups, including a placebo group

Laquinimod 0.3 mg

Active Comparator group

Description:

Laquinimod 0.3 mg

Treatment:

Drug: laquinimod 0.3

Laquinimod 0.6 mg

Active Comparator group

Description:

Laquinimod 0.6 mg

Treatment:

Drug: laquinimod 0.6

Placebo

Placebo Comparator group

Description:

Blinded Placebo

Treatment:

Other: Placebo