Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS) - Full Text View

Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS) (ALLEGRO)

This study has been completed.

First Received on July 27, 2007. Last Updated on January 13, 2011 History of Changes

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00509145

Purpose

Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Laquinimod Drug: Placebo	Phase III

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:	Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

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:

Relapse Rate: Number of confirmed relapses during the double blind study period. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Accumulation of physical disability measured by the time to confirmed progression of EDSS during the study period. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
MRI Outcomes [ Time Frame: 12, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	December 2007
Study Completion Date:	December 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Laquinimod Laquinimod 0.6 mg capsule, oral, once daily Other Name: TV-5600
Placebo Comparator: 2	Drug: Placebo oral, once daily, capsule

Eligibility

Ages Eligible for Study:	18 Years to 55 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: NCT00509145

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Principal Investigator:

Giancarlo Comi

U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology

More Information

No publications provided

Responsible Party:	Siyu Liu, Vice President, North American Innovative Research & Development and Head of Global Clinical Operations, Teva Neuroscience
ClinicalTrials.gov Identifier:	NCT00509145 History of Changes
Other Study ID Numbers:	MS-LAQ-301, EUDRACT 2007-003226-19
Study First Received:	July 27, 2007
Last Updated:	January 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:

Relapsing
Remitting

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 07, 2012