EUCTR2005-004334-41-CZ进行中（未招募）1 期
An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) 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 Ltd0 个研究点目标入组 105 人开始时间: 2006年1月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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