A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod

• ClinicalTrials.gov Identifier: NCT00349193
• Recruitment Status: Completed
• First Posted: July 6, 2006
• Last Update Posted: April 8, 2011
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Information provided by: Teva Branded Pharmaceutical Products R&D, Inc.

Tracking Information

• First Submitted Date: June 26, 2006
• First Posted Date: July 6, 2006
• Last Update Posted Date: April 8, 2011
• Study Start Date: March 2005
• Actual Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 7, 2011): Reduction of brain lesions in the last 4 months of the study [ Time Frame: 36 weeks ]
• Original Primary Outcome Measures (submitted: July 5, 2006): Reduction of brain lesions in the last 4 months of the study
• Current Secondary Outcome Measures (submitted: April 7, 2011): Relapse rate [ Time Frame: 36 weeks ]
• Original Secondary Outcome Measures (submitted: July 5, 2006): Relapse rate
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Relapsing Remitting Multiple Sclerosis

Intervention

• Drug: laquinimod 0.3
  laquinimod 0.3mg
• Drug: laquinimod 0.6
  laquinimod 0.6mg
• Other: Placebo
  Blinded Placebo

Study Arms

• Active Comparator: Laquinimod 0.3 mg
  Laquinimod 0.3 mg
  Intervention: Drug: laquinimod 0.3
• Active Comparator: Laquinimod 0.6 mg
  Laquinimod 0.6 mg
  Intervention: Drug: laquinimod 0.6
• Placebo Comparator: Placebo
  Blinded Placebo
  Intervention: Other: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 7, 2011): 306
• Original Enrollment (submitted: July 5, 2006): 264
• Actual Study Completion Date: August 2006
• Actual Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Italy

Administrative Information

• NCT Number: NCT00349193
• Other Study ID Numbers: LAQ/5062; 2004-003943-28 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ekkehard Baader, MD, Teva Pharmaceutical Europe B.V.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Original Study Sponsor: Teva Neuroscience, Inc.
• Collaborators: Not Provided

Investigators

• Study Chair: Prof. Giancarlo Comi; Teva Pharmaceutical Industries, Ltd.

• PRS Account: Teva Branded Pharmaceutical Products R&D, Inc.
• Verification Date: April 2011