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A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries Identifier:
First received: January 8, 2010
Last updated: December 1, 2016
Last verified: December 2016
To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.

Condition Intervention Phase
Relapsing Multiple Sclerosis
Drug: Laquinimod
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • To assess the long-term safety and tolerability of Laquinimod 0.6 mg, by analyzing rates and severity of adverse events and serious adverse events changes in laboratory parameters and physical examination findings. [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • To assess the long-term effects of laquinimod 0.6 mg on the disease course by analyzing relapse rate, progression of physical disability (EDSS and MSFC scores), fatigue and low-contrast visual acuity. [ Time Frame: 3 years ]

Enrollment: 1047
Study Start Date: April 2010
Estimated Study Completion Date: October 2023
Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Drug: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all Termination visit activities) according to the MS-LAQ-302 protocol.
  2. Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)] during the study and up to 30 days after the last dose of the study drug..
  3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
  4. Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-302E study.

Exclusion Criteria:

  1. Premature discontinuation from the MS-LAQ-302 study, for any reason.
  2. Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit] or breastfeeding.
  3. Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-302 study, which preclude safe participation and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-302E study.
  4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01047319

  Show 136 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Principal Investigator: Prof. Timothy Vollmer, MD University of Colorado, Denver
  More Information

Responsible Party: Teva Pharmaceutical Industries Identifier: NCT01047319     History of Changes
Other Study ID Numbers: MS-LAQ-302E
2009-015815-42 ( EudraCT Number )
Study First Received: January 8, 2010
Last Updated: December 1, 2016

Keywords provided by Teva Pharmaceutical Industries:
Relapsing Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Disease Progression
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes processed this record on May 25, 2017