NCT05211154终止4 期
A Randomized, Parallel-Group, Single-Attack, Open-Label Study to Evaluate the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine (ATOM)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pain freedom at 2 hours
研究概览
简要总结
In a real-world population of adults with migraine, the investigators would like to investigate whether 50 mg diclofenac potassium is non-inferior to 75 mg rimegepant in terms of pain freedom at 2 hours after drug intake.
详细描述
The study design is a randomized, open-label, parallel-group, single-attack study with 50 mg diclofenac potassium and 75 mg rimegepant. 645 patients with migraine with or without aura according to the third edition of the International Classification of Headache Disorders (ICHD-3) will be included.
Each subject will randomly be allocated to one treatment, and given 42 days to treat a single qualifying migraine attack of moderate to severe intensity.
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
- None
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
- •Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- •Aged 18 to 65 years upon entry into screening
- •History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the ICHD-3 criteria based on medical records and/or patient self-report.
- •Not more than 12 attacks per month with moderate to severe headache pain in each of the previous 3 months.
排除标准
- •Disease Related
- •Greater than 50 years of age at migraine onset
- •History of cluster headache or hemiplegic migraine headache
- •Inability to differentiate between migraine 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 months in the previous 3 months
- •Has a history of migraine aura with diplopia or impairment of levels of consciousness, hemiplegic migraine, or retinal migraine.
- •Required hospital treatment of a migraine attack 3 or more times in the previous 6 months.
- •Other Medical Conditions
- •The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- •Has a chronic non-headache pain condition requiring daily pain medication
- •Has a history of any prior gastrointestinal conditions (e.g., 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 malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- •History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •Medication related
- •Start of new preventive migraine treatment within the last two months
- •Change in dosage of ongoing preventive migraine treatment within the last two months
- •Current preventive treatment with monoclonal antibodies targeting calcitonin gene related piptide (CGRP) or CGRP receptors, or current use of small-molecule CGRP receptor antagonist (e.g. erenumab, fremanezumab, galcaneszumab, atogeptant or rimegepant)
- •Changes in treatment with selective serotonin reuptake inhibitors (SSRI) or serotonin norepinephrine reuptake inhibitors (SNRI) within the last two months
- •Use of the following medication within 30 days prior to screening:
- •Strong and moderate cytochrome P450 3A4 (CYP3A4) inhibitors, including but not limited to systemic (oral/IV) itraconazole, ketoconazole, fluconazole; erythromycin, clarithromycin, telithromycin; diltiazem, verapamil; aprepitant; cyclosporine; nefazodone; cimetidine; quinine; and HIV protease inhibitors
- •Strong and moderate CYP3A4 inducers, including but not limited to barbiturates (eg, phenobarbital and primidone), systemic (oral/IV) glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, rifampin, rifabutin, and St. John's wort
- •Inhibitors of the BCRP (breast cancer resistance protein) transporter (eg, rifampicin)
- •Drugs with narrow therapeutic margins (eg, digoxin, warfarin)
- •Other Exclusions
- •Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
- •Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product.
- •Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product.
- •Evidence of current pregnancy or breastfeeding per subject self-report or medical records
- •Subject has known sensitivity to any of the products or components to be administered during dosing.
- •Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
研究组 & 干预措施
Diclofenac Potassium (soluble)
Experimental
50 mg diclofenac potassium taken orally once
干预措施: Diclofenac Potassium 50Mg/Pkt Oral Pwdr (Drug)
Rimegepant
Active Comparator
75 mg rimegepant taken orally once
干预措施: Rimegepant 75 MG (Drug)
结局指标
主要结局
Pain freedom at 2 hours
时间窗: 2 hours after initial dose
Pain freedom will be subjectively rated by the patient in a headache diary
次要结局
未报告次要终点
研究者
Messoud Ashina, MD
Professor
Danish Headache Center
研究点 (1)
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