A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod Tablets in the Treatment of Relapsing-Remitting Multiple Sclerosis (R-R MS)Followed by an Open Label Phase of Laquinimod 0.6 mg Daily. - Full Text View

Purpose

This is a continuation of the LAQ/5062 study as a multinational, multicenter, randomized, double-blind, parallel group study, assessing the safety, tolerability and efficacy of two doses of laquinimod in subjects with R-R MS followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL).

Subjects entering this randomized, two active arms study immediately after completion of the LAQ/5062 core study.

Subjects entering the open-label phase (LAQ/5063 OL) upon the termination visit of LAQ/5063 active double-blind phase

Subjects previously treated with placebo in the LAQ/5062 study are equally randomized to one of the active treatment groups:

0.6 mg of laquinimod per os (p.o.) once daily 0.3 mg of laquinimod p.o. once daily Subjects previously treated with laquinimod 0.6 mg or laquinimod 0.3 mg continuing on their original treatment assignment.

Upon the termination visit of LAQ/5063 active double-blind phase (completion of the full 36 weeks or as requested by the Sponsor) and after meeting the eligibility criteria of the open-label phase, all subjects are treated with laquinimod 0.6 mg once daily

Condition	Intervention	Phase
Relapsing Remitting Multiple Sclerosis	Drug: laquinimod	Phase II

MedlinePlus related topics:

Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	An Active Extension of LAQ/5062 Study. A Multinational, Multi-Center, Randomized, Double-Blind, Parallel-Group Study, to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3mg and 0.6mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects Followed by an Open Label Phase of Laquinimod 0.6 mg Daily.

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Safety - Adverse Events, Physical examinations, Vital signs and ECG, Clinical laboratory parameters [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tolerability - Number and percentage of subjects who prematurely discontinued from the study [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	264
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 0.6 mg laquinimod once daily	Drug: laquinimod 0.6 mg, oral, once daily, for 36 weeks
2: Active Comparator 0.3 mg laquinimod once daily	Drug: laquinimod 0.3 mg, oral, once daily, for 36 weeks

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.
Subjects must be in a stable neurological condition and free of corticosteroid treatment.
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
Pregnancy or breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745615

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators


Principal Investigator:	Giancarlo Comi	Astituto Scientifico Fondazione Centro S. Raffaele

More Information

Responsible Party:	Teva Neuroscience ( Siyu Liu, Vice President, North American IR&D and Head of Global Clinical Operations )
Study ID Numbers:	LAQ-5063, EUDRACT 2005-004334-41
First Received:	September 2, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00745615
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; United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes

Immune System Diseases

Nervous System Diseases

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00745615