EUCTR2010-019288-13-FI进行中(未招募)不适用
A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 4,500
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
- Female
入选标准
- •1. female who has regular menstrual cycles monthly (22 to 32 days) for at least the last 3 cycles. 2. history of migraine with or without aura for = 3 months and with =2 migraine attacks per month in te 2 months prior to screening. 3. headache during menstrual period in at least 2 out of last 3 cycles.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. patient has basilar or hemiplegic migraine headache. 2. patient has taken medication for acute headache atttack on more than 15 days per month in any of the 3 months prior to screening. 3. patient is taking migraine prophylactic medication where the prescribed daily dose has changed during the 4 weeks prior to screening. 4. history of liver disease. 5. consumes 3 or more alcoholic drinks per day. 6. history of neoplastic disease = 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
研究者
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A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraineheadache10019231migraineNL-OMON34533Merck Sharp & Dohme (MSD)150
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A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine - MK0974-065MedDRA version: 12.1Level: LLTClassification code 10027599Term: MigraineMigraineEUCTR2010-019288-13-NLMerck, Sharp & Dohme B.V.4,500
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A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients with Episodic MigraineMedDRA version: 12.1Level: LLTClassification code 10027599Term: MigraineMigraineEUCTR2010-019288-13-SEMSD4,500
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A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerabitlity, and Efficacy of Telcagepant (MK-0974) for prevention of Menstrually Related Migraine in Female Patients with Episodic MigraineMigraineEUCTR2010-019288-13-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.4,500
进行中(未招募)
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A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients with Episodic MigraineMigraineEUCTR2010-019288-13-DKMerck Sharp & Dohme Corp.4,500
