A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course (NCT00988052) | Clinical Trial Compass
TerminatedPhase 3
A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
Stopped: Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.
United States839 participantsStarted 2009-11-10
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol.
✓. 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..
✓. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
✓. Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E study.
Exclusion criteria
✕. Premature discontinuation from the MS-LAQ-301 study, for any reason.
✕. Pregnancy \[according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit\] or breastfeeding.
✕
What they're measuring
1
Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Day 1 up to 7.64 years
Trial details
NCT IDNCT00988052
SponsorTeva Branded Pharmaceutical Products R&D, Inc.
. 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.
✕. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).