A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- laquinimod 0.3
- laquinimod 0.6
- Laquinimod
Placebo or sham
- Placebo
What it measured
Main measures
Reduction of brain lesions in the last 4 months of the study
36 weeks
MRI lesionsThe cumulative number of enhancing lesions on T1-weighted images taken on weeks 12, 16, 20, 24, 28, 32 and 36 (primary end point).
MRI lesions
Other measures (1)
Relapse rate
36 weeks
Relapses
Who could take part
Relapsing MS · 18 to 50
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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
Compared with placebo, treatment with laquinimod 0.6 mg per day showed a 40.4% reduction of the baseline adjusted mean cumulative number of GdE lesions per scan on the last four scans (simple means 4.2 [SD 9.2] vs 2.6 [5.3], p=0.0048); treatment with 0.3 mg per day showed no significant effects (3.9 [5.5] vs placebo, p=0.6740).
Read by software from the paper's abstract
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Linked trials
Extended by
An Extension Study of LAQ/5062 Exploring the Long Term Sa…Phase 2 · Stopped early
Links found where a registry record names another trial's registry number.
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History
Started
Mar 2005
Main results due
Jun 2006
Finished
Aug 2006
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