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

Relapsing Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349193
• Other study ID #: LAQ/5062
• Secondary ID: 2004-003943-28
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2006
• Last updated: April 7, 2011
• Start date: March 2005
• Est. completion date: August 2006

Study information

• Verified date: April 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ethics CommitteePoland: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: August 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• laquinimod 0.3
laquinimod 0.3mg
• laquinimod 0.6
laquinimod 0.6mg

Other:
• Placebo
Blinded Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of brain lesions in the last 4 months of the study		36 weeks	No
Secondary	Relapse rate		36 weeks	No