A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 1,672
- 试验地点
- 87
- 主要终点
- Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
研究概览
简要总结
This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version
- •Migraine onset before age 50
- •History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
- •History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months.
排除标准
- •Difficulty distinguishing migraine headache from other headaches
- •Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
- •Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
- •Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
- •Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
- •Has a chronic non-headache pain condition requiring daily pain medication
- •Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- •Has a history of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded
- •Has a history of hepatitis within previous 6 months.
研究组 & 干预措施
Ubrogepant 50 mg
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
干预措施: Ubrogepant (Drug)
Ubrogepant 50 mg
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
干预措施: Placebo-matching Ubrogepant (Drug)
Ubrogepant 100 mg
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
干预措施: Ubrogepant (Drug)
Ubrogepant 100 mg
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
干预措施: Placebo-matching Ubrogepant (Drug)
Placebo
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
干预措施: Placebo-matching Ubrogepant (Drug)
结局指标
主要结局
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
时间窗: Baseline (Predose) to 2 hours after initial dose
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms.
Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
时间窗: Baseline (Predose) to 2 hours after initial dose
Pain freedom was defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
次要结局
- Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose(2 hours after initial dose)
- Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose(2 hours after initial dose)
- Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose(Baseline (Predose) to 2 hours after initial dose)
- Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose(2 to 24 hours after initial dose)
- Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose(2 to 24 hours after initial dose)
- Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose(2 hours after initial dose)