This trial is active, not recruiting.

Condition relapsing multiple sclerosis
Treatment laquinimod
Phase phase 3
Sponsor Teva Pharmaceutical Industries
Start date April 2010
End date October 2023
Trial size 1047 participants
Trial identifier NCT01047319, 2009-015815-42, MS-LAQ-302E


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
One capsule containing 0.6 mg laquinimod to be administered orally once daily.

Primary Outcomes

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 Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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).

Additional Information

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
Principal investigator Prof. Timothy Vollmer, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Teva Pharmaceutical Industries.