This trial is active, not recruiting.

Condition relapsing multiple sclerosis (rms)
Treatment laquinimod
Phase phase 3
Sponsor Teva Pharmaceutical Industries
Start date November 2009
End date September 2023
Trial size 844 participants
Trial identifier NCT00988052, 2009-012989-30, MS-LAQ-301E


The purpose of this study is to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 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

time frame: 3 years

Secondary Outcomes

time frame: 3 years
Long-term effect on disease course
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: 1. Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 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-301E study. Exclusion Criteria: 1. Premature discontinuation from the MS-LAQ-301 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-301 study, which preclude safe participation and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-301E 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-301 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 Giancarlo Comi, Prof., MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Teva Pharmaceutical Industries.