A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod - Full Text View

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00349193

Purpose

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	Intervention	Phase
Relapsing Remitting Multiple Sclerosis	Drug: laquinimod 0.3 Drug: laquinimod 0.6 Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: ABR 215062

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Reduction of brain lesions in the last 4 months of the study [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relapse rate [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment:	306
Study Start Date:	March 2005
Study Completion Date:	August 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349193

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Chair:

Prof. Giancarlo Comi

Teva Pharmaceutical Industries

More Information

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Ekkehard Baader, MD, Teva Pharmaceutical Europe B.V.
ClinicalTrials.gov Identifier:	NCT00349193 History of Changes
Other Study ID Numbers:	LAQ/5062, 2004-003943-28
Study First Received:	June 26, 2006
Last Updated:	April 7, 2011
Health Authority:	Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: Ethics Committee; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Teva Pharmaceutical Industries:

Relapsing Remitting Multiple Sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012