Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Teva Pharmaceutical Industries Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria For The Open-Label Phase 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 (for example women who are not postmenopausal or surgically sterilized) must practice two 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 include: intrauterine devices, barrier methods (condom or diaphragm with spermicide), and hormonal methods of birth control (e.g. oral contraceptive, contraceptive patch, and long-acting injectable contraceptive)]. 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 open label phase (LAQ/5063 OL). Inclusion Criteria for the LAQ/5063 OL open-label phase - further extension (after visit month 24) Subjects must have completed the 24 months of treatment of the first period of the open label phase Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria for the LAQ/5063 OL open-label phase 1) Premature discontinuation from LAQ/5063 active double-blind phase for anyreason 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 double blind 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 open label 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) 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 period from termination of LAQ/5063 active double-blind phase to the open-label phase (LAQ/5063 OL) 9) Use of amiodarone in the period from termination of LAQ/5063 active double blind 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To make treatment with laquinimod available to all subjects who previously participated in both the LAQ/5062 study and the LAQ/5063 active double-blind phase (completion of the full 36 weeks or as requested by the Sponsor). To assess the long-term safety, and tolerability in the group that received active treatment in LAQ/5062 protocol and additional short term safety and tolerability in the group who received placebo treatment. The LAQ/5063 OL phase will assess long-term safety and tolerability of 0.6 mg laquinimod administered once daily. Further efficacy data will be obtained by comparing baseline to termination in the group who received placebo treatment in LAQ/5062 (core study) protocol. ;Secondary Objective: Not applicable; Primary end point(s): Primary Outcome: Long Term Safety ;Timepoint(s) of evaluation of this end point: Safey assessments will be performed at each study visit (every 6 months) and / or monitored throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Czech Republic, Germany, Hungary, Israel, Italy, Poland, Russian Federation, Spain, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Teva GmbH
Outcome results
None listed