EUCTR2005-004334-41-ITActive, not recruitingPhase 1
An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) of laquinimod, orally administered in relapsing remitting (R-R) Multiple Sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL).
Teva Pharmaceutical Industries Ldt0 sites246 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 246
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Subjects 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. 2. Women of child- bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: double barrier methods such as diaphragms with spermicide, condoms and spermicide. Also intrauterine devices; hormonal contraception must be accompanied by an additional method of birth control.). 3. Subjects must be willing and able to comply with the protocol requirements for the duration of the open-label phase (LAQ/5063 OL). 4. Subjects must give signed, written informed consent prior to entering the openlabel phase (LAQ/5063 OL). Inclusion Criteria for the LAQ/5063 OL open-label phase - further extension (after visit month 24) a. Subjects must have completed the 24 months of treatment of the first period of the open label phase. b. Women of child- bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: double barrier methods such as diaphragms with spermicide, condoms and spermicide. Also intrauterine devices; hormonal contraception must be accompanied by an additional method of birth control).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Premature discontinuation from LAQ/5063 active double-blind phase for any reason other than sponsor`s request 2. Pregnancy or breastfeeding 3. Subjects with clinically significant or unstable medical or surgical condition, detected or worsened during the active double-blind phase of LAQ/5063, which would preclude safe and complete study participation 4. Use of experimental drugs, immunosuppressive drugs, and/or participation in clinical studies within the period from termination of LAQ/5063 active doubleblind phase to the open-label phase (LAQ/5063 OL) 5. Previous treatment with immunomodulators with the exception of laquinimod (including IFN 1a and 1b, Glatiramer Acetate and IVIG) within 2 months prior to entering the open-label phase for those subjects who have a time gap between termination of LAQ/5063 active double-blind phase to the open-label phase (LAQ/5063 OL) 6. Use of corticosteroids within 30 days prior to entering the open-label phase, except for IV methylprednisolone 1 g/day for a maximum of 3 days, in the period from termination of LAQ/5063 active double-blind phase to the openlabel phase (LAQ/5063 OL) 7. Use of potent inhibitors of CYP3A4 within 2 weeks prior to open label phase (LAQ/5063 OL) and/or use of fluoxetine one month prior entering the open label phase (LAQ/5063 OL), in the period from termination of LAQ/5063 active double-blind phase to the open-label phase (LAQ/5063 OL) (see list in appendix 5) 8. Use of the following substrates of CYP1A2: theophylline and/or warfarin within 2 weeks prior to entering the open-label phase (LAQ/5063 OL), in the label phase (LAQ/5063 OL) 9. Use of amiodarone in the period from termination of LAQ/5063 active doubleblind phase to the open-label phase (LAQ/5063 OL) 10. Following the switch to new formulation (capsules), hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate. Exclusion Criteria for the LAQ/5063 OL open-label phase- further extension (after visit month 24) a. Premature discontinuation from LAQ/5063 OL phase prior to completion of 24 months of treatment period b. Pregnancy or breastfeeding.
Investigators
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