An Open Label Extension of the LAQ/5062 and LAQ/5063 Studies to Assess the Long Term Safety and Tolerability of Laquinimod 0.6mg in RRMS Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00745615
First received: September 2, 2008
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

This is a continuation of the LAQ/5063 study which was a multinational, multicenter, randomized, double-blind, parallel group study, assessing the safety, tolerability and efficacy of two doses of laquinimod in subjects with R-R MS followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL).

Subjects entering this randomized, two active arms study immediately after completion of the LAQ/5062 core study.

Subjects entering the open-label phase (LAQ/5063 OL) upon the termination visit of LAQ/5063 active double-blind phase

Subjects previously treated with placebo in the LAQ/5062 study are equally randomized to one of the active treatment groups:

0.6 mg of laquinimod per os (p.o.) once daily 0.3 mg of laquinimod p.o. once daily Subjects previously treated with laquinimod 0.6 mg or laquinimod 0.3 mg continuing on their original treatment assignment.

The LAQ/5063 study assessed the 0.3mg and the 0.6mg daily doses of laquinimod in patients who completed the LAQ/5062 study.

Upon the termination visit of LAQ/5063 active double-blind phase (completion of the full 36 weeks or as requested by the Sponsor) and after meeting the eligibility criteria of the open-label phase, all subjects began treatment with laquinimod 0.6 mg once daily for 24 months In the current phase, this open-label extension is further extended in additional 36 months of treatment with laquinimod 0.6mg once daily.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: laquinimod
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: [An Active Extension of LAQ/5062 Study. A Multinational, Multi-center, Randomized, Double-blind, Parallel-group Study, to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3mg and 0.6mg) of Laquinimod,] Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects Followed by an Open Label Phase of Laquinimod 0.6 mg Daily.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • long-term safety and tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 211
Study Start Date: December 2006
Estimated Study Completion Date: January 2024
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
0.6 mg laquinimod once daily
Drug: laquinimod
0.6 mg, oral, once daily

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • For the 36 months further extension: Subjects must have completed the 24 months of treatment of the first period of the open label phase
  • Women of child-bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: double barrier methods such as diaphragms with spermicide, condoms and spermicide. Also intrauterine devices; hormonal contraception must be accompanied by an additional method of birth control.)

Exclusion Criteria

  • For the 36 month further extension: Premature discontinuation from Laq/5063 OL phase prior to completion of 24 months of treatment period
  • pregnancy or breast feeding
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745615

  Show 45 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Giancarlo Comi Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00745615     History of Changes
Other Study ID Numbers: LAQ/5063OL, EUDRACT 2005-004334-41
Study First Received: September 2, 2008
Last Updated: July 29, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2014