Status:
TERMINATED
A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief 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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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).
Key Trial Info
Start Date :
November 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
839 Patients enrolled
Trial Details
Trial ID
NCT00988052
Start Date
November 10 2009
End Date
July 1 2017
Last Update
December 9 2021
Active Locations (135)
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1
Teva Investigational Site 1076
Phoenix, Arizona, United States, 85004
2
Teva Investigational Site 1090
Centennial, Colorado, United States, 80112
3
Teva Investigational Site 1088
Fort Collins, Colorado, United States, 80528
4
Teva Investigational Site 1102
Northbrook, Illinois, United States, 60062