2026-525521-20-00招募中2 期
The headache- and migraine-inducing effects of pitolisant in women with migraine without aura
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The occurrence of migraine-like attacks in pitolisant- and placebo-treated women with migraine without aura
研究概览
简要总结
We will test the ability of a single oral administration of pitolisant (18 mg) to induce migraine in women with a history of migraine without aura.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women with a diagnosis of episodic migraine without aura according to the International Classification
- •Safe contraception (including hormonal therapies, intrauterine devices and/or oral pills) during the entire period of the study
- •Age: 18-65 years
- •Weight: 50-90 kg
- •Fluency in Danish or English
排除标准
- •Any other type of headache (excluding < 3 days of tension-type headache per month), according to the International Classification
- •Known allergy to any component of pitolisant “Wakix”
- •Member of investigational site staff or relative of investigators
- •Headache less than 24 hours before the start of the experiment
- •Drinking coffee, cola or alcohol less than 8 hours before the start of the experiment
- •Assumption of analgesic medications in the 24 hours preceding the experimental days
- •History or clinical evidence of severe psychiatric disorders (including anxiety or depression), clinically significant cardiovascular disease, severe epilepsy, and hepatic and/or renal impairment
- •Concomitant use of antihistamines, antidepressants, strong CYP3A4 inducers, CYP2D6 inhibitors, or drugs that are substrates of the organic cation transporter 1 (OCT1)
- •Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study
- •Use of concomitant medications that have changed in dosage within 14 days prior to screening or are expected to change during the study period
- •Positive pregnancy test at the Screening and/or before the start of the experiment
结局指标
主要结局
The occurrence of migraine-like attacks in pitolisant- and placebo-treated women with migraine without aura
The occurrence of migraine-like attacks in pitolisant- and placebo-treated women with migraine without aura
次要结局
- Headache intensity over time, expressed as the area under the curve (AUC), following pitolisant and placebo administration in women with migraine without aura
- The occurrence of any headache, irrespective of migraine criteria, following pitolisant and placebo administration
研究者
Lanfranco Pellesi
Scientific
Syddansk Universitet (University of Southern Denmark)
研究点 (1)
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