A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
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|ClinicalTrials.gov Identifier: NCT00349193|
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : April 8, 2011
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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 or disease||Intervention/treatment||Phase|
|Relapsing Remitting Multiple Sclerosis||Drug: laquinimod 0.3 Drug: laquinimod 0.6 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||August 2006|
Active Comparator: Laquinimod 0.3 mg
Laquinimod 0.3 mg
Drug: laquinimod 0.3
Active Comparator: Laquinimod 0.6 mg
Laquinimod 0.6 mg
Drug: laquinimod 0.6
Placebo Comparator: Placebo
- Reduction of brain lesions in the last 4 months of the study [ Time Frame: 36 weeks ]
- Relapse rate [ Time Frame: 36 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349193
|Study Chair:||Prof. Giancarlo Comi||Teva Pharmaceutical Industries, Ltd.|
|Responsible Party:||Ekkehard Baader, MD, Teva Pharmaceutical Europe B.V.|
|Other Study ID Numbers:||
2004-003943-28 ( EudraCT Number )
|First Posted:||July 6, 2006 Key Record Dates|
|Last Update Posted:||April 8, 2011|
|Last Verified:||April 2011|
Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases