A Clinical Trial to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- % of patients reporting no headache pain.
研究概览
简要总结
The study consists of a screening visit, out-patient treatment of a moderate or severe migraine attack with a single dose of the study medication within 8 weeks, and End-of-Study Visit 2-7 days after dosing.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years of age or older.
- •History of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version) for at least one-year with first migraine prior to age
- •Migraine-associated nausea with ≥half of migraine attacks.
- •2 - 8 migraines per month in each of the previous 3 months.
- •The patient is able to complete study questionnaires, comply with the study requirements and restrictions, and willing to provide written informed consent and authorize HIPAA.
- •The female patient who is premenopausal or postmenopausal less than 1 year, or have not had surgical sterilization (i.e., tubal ligation, partial or complete hysterectomy) must have a negative urine pregnancy test, be non-lactating, and commit to using adequate and reliable contraception throughout the study (e.g., barrier with additional spermicidal, intra-uterine device, hormonal contraception). The male patient must be surgically sterile or commit to the use of 2 different methods of birth control during the study and for 28 days after taking the study drug.
排除标准
- •The patient in the opinion of the investigator, may have medication-overuse headache pain (as defined by ICHD - 3 beta criteria for medication-overuse headache), (analgesic, opioid, ergotamine or triptan overuse) during the 3 months preceding screening.
- •The patient in the opinion of the investigator has chronic migraine (as defined by ICHD - 3 beta criteria for chronic migraine).
- •History of cluster headache or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic migraine).
- •Initiation or change in medications with possible migraine prophylactic effects during 3 months before inclusion into the trial (E.g., calcium channel blockers, tricyclic antidepressants, beta-blockers, selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), or Botox).
- •Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment.
- •A history within the previous 3 years of abuse of any drug, prescription, illicit, or alcohol.
- •The Female patient is pregnant or breast-feeding. The Male patient is not practicing 2 different methods of birth control with their partner during the study, and for 28 days after the investigational drug last dose or will not remain abstinent during the study, and for 28 days after the last dose.
- •Use of opiates or barbiturates more than 3 days per month.
- •Known-hypersensitivity reaction to any of the components of the investigational drug.
- •Consumption of analgesic medication for other conditions on a regular basis, (nonsteroidal anti-inflammatory drugs, or acetaminophen, or muscle relaxants).
- •Use of emergency care treatment more than 3 times in the previous 6 months.
- •Participation in another study with an investigational drug within 30 days prior to randomization and/or a plan to participate during the study.
研究组 & 干预措施
Naltrexone and Acetaminophen
Patients take one capsule containing naltrexone and one capsule containing acetaminophen together for a qualifying migraine
干预措施: Naltrexone and Acetaminophen (Drug)
Naltrexon/Acetaminophen-High Capsules
Patient take one capsule containing naltrexone (high dose) and one capsule containing acetaminophen together for a qualifying migraine
干预措施: Naltrexone and Acetaminophen-High Dose (Drug)
Naltrexone Alone Capsules
Patient take one capsule containing naltrexone and one capsule containing placebo together for a qualifying migraine
干预措施: Naltrexone Alone (regular dose) (Drug)
Acetaminophen Alone Capsules
Patient take one capsule containing naltrexone and one capsule containing placebo together for a qualifying migraine
干预措施: Acetaminophen Alone (Drug)
Placebo Capsules
Patient take two capsule containing placebo together for a qualifying migraine
干预措施: Matching Placebo (Drug)
结局指标
主要结局
% of patients reporting no headache pain.
时间窗: 2 hours post-dose
Self-reported headache pain on a four-point Likert scale.
% of patients having absence of most bothersome migraine-associated symptom (MBS).
时间窗: 2 hours post-dose
MBS was prospectively identified at baseline. Self-reported MBS as present or absent.
% of patients who have "sustained pain freedom"
时间窗: 24-hour post-dose.
Defined as having no headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain within 24 hours after administration of the investigational drug.
次要结局
- % of patients who had headache pain relapse.(2-48 hours)
- % of patients having absence of nausea, photophobia, phonophobia, and neck/shoulder pain(24-hour post-dose.)
- % of patients who used rescue medications(2-24 hours)