A Phase 2 Study of the Safety and Effectiveness of a Single Oral Dose of NXN 188 for the Treatment of Moderate to Severe Migraine Headache With Aura
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 16
- 主要终点
- Time (Hours) to First Use of Rescue Medication
研究概览
简要总结
NXN-188 Dihydrochloride is being developed as an immediate release oral product for the treatment of acute migraine. This study is being conducted to evaluate NXN-188 in subjects with a migraine history of aura.
详细描述
This was a multicenter, double-blind, parallel group, active and placebo-controlled, three arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache with aura.
After study eligibility was confirmed, subjects were randomized to NXN-188 600 mg, sumatriptan 100 mg, or placebo in a 1:1:1 ratio. Subjects left the clinic to self-administer the treatment at home at the onset of moderate to severe headache in a suitable dosing environment.
Treatment was not to exceed 42 days from Randomization. If the subject did not have a headache within 42 days of randomization (s)he did not take the study medication and returned it to the site. If the subject experienced a qualifying headache (s)he recorded the symptoms in a diary, dosed with the study drug, and called the IVRS to record assessments all adverse events and to report dosing. If the study drug provided insufficient relief 2 hours post dosing (s)he was permitted to use non-triptan rescue medication recommended by the investigator.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female migraineurs between 18 and 65 years old.
- •Subjects must have a headache history of migraine with aura as defined by:
- •Aura consisting of at least one of the following, but no muscle weakness or paralysis:
- •Fully reversible visual symptoms
- •Fully reversible sensory symptoms
- •Fully reversible dysphasia
- •Aura has at least two of the following characteristics:
- •Visual symptoms affecting only one side of the field of vision and/or sensory symptoms affecting only one side of the body
- •At least one aura symptom that develops gradually over more than 5 minutes and/or different aura symptoms occur in succession over more than 5 minutes
- •Each symptom lasts from 5-60 minutes
- •Headache begins during the aura or follows aura within 60 minutes
- •Headache not attributable to another disorder
- •Migraine pain following aura in at least 75% of occurrences
- •Headache frequency of at least 1 migraine attack (with or without aura) per month for the past 3 months but not more than 8 migraines in any 30 day period. Subjects must have at least 1 migraine headache with aura per month
- •Each migraine attack should last at least 4 hours (without treatment) and not longer than 72 hours.
- •At the time of the study migraine, prior to dosing with study medication, the headache severity, as judged and documented by the subject, is either moderate or severe (on a 4-point categorical scale)
- •Body mass index (BMI) range of 18 to 35
- •The subject is in general good health.
- •ALT cannot be above 1.5x upper limit of normal; creatinine and urea must be within normal limits
- •Speak, read, and understand English, French, or Spanish sufficiently to understand the nature of the study, to provide written informed consent, and complete all study assessments
- •The subject is willing and able to comply with all testing requirements defined in the protocol
- •All females will avoid pregnancy at least 10 days before randomization, and up until 3 months after dosing.
- •All subjects/partners must use a double-barrier method of birth control during the study and for 3 months after dosing.
排除标准
- •A diagnosis of headaches that is not consistent with migraine with aura.
- •Presence of any risk factors that would preclude the use of triptans:
- •Known allergy or hypersensitivity to triptans or history of any serious side effect with a triptan which would preclude further dosing with a triptan
- •Presence of any clinically significant condition that would preclude study participation, as evaluated by the investigator
- •Pregnancy or lactation
- •History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease
- •Use of the following if taken for migraine prevention:
- •Cardiovascular drugs (acceptable if reason for use is for treatment of cardiovascular disease and the subject has been on a stable dose for 3 months)
- •Valproate, topiramate, cyproheptadine, montelukast, or botulinum toxin.
- •Use of monoamine oxidase inhibitors within 30 days of randomization
- •Initiation of therapy with SSRIs or SNRIs for depression or other approved indication within 90 days of randomization (subjects on stable dose for >3 months for treatment of depression or other approved indication may be included)
- •Are known to or suspected to be currently abusing alcohol or drugs, or have a history (within the past 12 months) of active alcohol or drug abuse
- •Participation in another drug or biologic study within 30 days of randomization into this study or during participation in this study
- •Subjects who are unable or unwilling, in the opinion of the Investigator, to comply with all study procedures and cooperate fully with study center staff
研究组 & 干预措施
NXN-188
NXN-188, 600 mg, PRN
干预措施: NXN-188 (Drug)
sumatriptan succinate 100 mg
Sumatriptan, 100 mg, PRN
干预措施: sumatriptan succinate (Drug)
placebo
matching, PRN
干预措施: placebo (Drug)
结局指标
主要结局
Time (Hours) to First Use of Rescue Medication
时间窗: 24 hours
次要结局
- Headache Relief and Recurrence (Observed Cases)(2, 4 and up to 24 hours)
- 2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea(2 hours)
- 4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea(4 hours)
- 24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea(24 hours)