A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
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
2 other identifiers
interventional
306
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2005
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 26, 2006
CompletedFirst Posted
Study publicly available on registry
July 6, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedApril 8, 2011
April 1, 2011
1.3 years
June 26, 2006
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of brain lesions in the last 4 months of the study
36 weeks
Secondary Outcomes (1)
Relapse rate
36 weeks
Study Arms (3)
Laquinimod 0.3 mg
ACTIVE COMPARATORLaquinimod 0.3 mg
Laquinimod 0.6 mg
ACTIVE COMPARATORLaquinimod 0.6 mg
Placebo
PLACEBO COMPARATORBlinded Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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. doi: 10.1016/S0140-6736(08)60918-6.
PMID: 18572078DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Prof. Giancarlo Comi
Teva Pharmaceutical Industries, Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 26, 2006
First Posted
July 6, 2006
Study Start
March 1, 2005
Primary Completion
June 1, 2006
Study Completion
August 1, 2006
Last Updated
April 8, 2011
Record last verified: 2011-04