Status:
TERMINATED
An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease
Lead Sponsor:
Teva Pharmaceutical Industries, Ltd.
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
This is a multinational, multicenter, randomized, double-blind, parallel-group active extension of LAQ/5062 study (NCT00349193), assessing the tolerability, safety and efficacy of two doses (0.3 mg an...
Eligibility Criteria
Inclusion
- Inclusion Criteria - Participants must have completed the 36 weeks of treatment (completion of the full 36 weeks or as requested by the Sponsor) of the active double-blind phase. - Women of childbearing potential (for example, women who were not postmenopausal or surgically sterilized) must have practiced 2 acceptable methods of birth control for the duration of the study and until 30 days after the last dose of study medication (acceptable methods of birth control in this open-label extension phase included intrauterine devices, barrier methods \[condom or diaphragm with spermicide\], and hormonal methods of birth control \[for example, oral contraceptive, contraceptive patch, and long-acting injectable contraceptive\]). - Participants must have been willing and able to comply with the protocol requirements for the duration of LAQ/5063 OL. - Participants must have given signed, written informed consent prior to entering LAQ/5063 OL. - For the 36 months further extension: Participants must have completed the 24 months of treatment of the first period of the open label phase. Exclusion Criteria - For the 36 month further extension: Premature discontinuation from LAQ/5063 OL phase prior to completion of 24 months of treatment period. - Pregnancy or breastfeeding. - Participants with clinically significant or unstable medical or surgical condition, detected or worsened during the active double-blind phase of LAQ/5063, which would have precluded safe and complete study participation. - Use of experimental drugs, immunosuppressive drugs, and/or participation in clinical studies within the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Previous treatment with immunomodulators with the exception of laquinimod (including interferon \[IFN\] 1a and 1b, glatiramer acetate, and intravenous \[IV\] immunoglobulin) within 2 months prior to entering the open-label phase for those subjects who had a time gap between termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of corticosteroids within 30 days prior to entering the open-label phase, except for IV methylprednisolone 1 grams/day for a maximum of 3 days, in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of potent inhibitors of cytochrome P3A4 (CYP3A4) within 2 weeks prior to LAQ/5063 OL and/or use of fluoxetine 1 month prior to entering LAQ/5063 OL, in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of the following substrates of cytochrome P1A2 (CYP1A2): theophylline and/or warfarin within 2 weeks prior to entering LAQ/5063 OL, in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of amiodarone in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Following the switch to new formulation (capsules), hypersensitivity to mannitol, meglumine, or sodium stearyl fumarate.
Exclusion
Key Trial Info
Start Date :
December 7 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2017
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00745615
Start Date
December 7 2005
End Date
July 23 2017
Last Update
March 27 2019
Active Locations (45)
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1
Teva Investigational Site 382
Hradec Králové, Czechia
2
Teva Investigational Site 380
Prague, Czechia
3
Teva Investigational Site 384
Praha 5- Motol, Czechia
4
Teva Investigational Site 681
Berlin, Germany