EUCTR2020-003761-18-PL进行中（未招募）1 期
Phase 3, multicenter, open-label study to assess the long-term safety and tolerability of rimegepant for the acute treatment of migraine (with or without aura) in children and adolescents = 6 to < 18 years of age
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed Written Informed Consent
- •a. The participant must be capable of communicating with the site personnel.
- •b. The participant is able to understand the Informed Assent Form (IAF) and the participant’s parent(s)/legal representative(s) (according to local regulations) are/is able to read and understand the Informed Consent Form (ICF).
- •c. The participant has signed the IAF and the participant’s parent(s)/legal representative(s) (according to local regulations) have/has signed the ICF prior to the conduct of any study-specific procedures.
- •d. The participant and the participant’s parent(s)/legal representative(s) (as required according to local regulations) are/is willing and able to attend study appointments within the specified time windows.
- •e. The participant must be able to read and comprehend written instructions and be willing to complete all questionnaires under supervision of legal representative(s) as required by the protocol.
- •2. Target Population
- •a. History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant’s parent(s)/legal representative(s).
- •b. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment. A history of attacks lasting approximately > 3 hours without treatment. History may be verified using both medical records and recall by the participant and/or participant’s parent(s)/legal representative(s).
- •c. Participant had 1 or more migraine days requiring treatment during the Observation Phase.
- •d. Participants on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.
- •e. Participants are required to verbally distinguish between migraine and other types of headaches.
- •f. Participants must have a weight = 40 kg (child cohort weight requirement = 15 kg).
- •g. Participants must have adequate venous access for blood sampling.
- •3. Age and Reproductive Status
- •a. Male and female participants > 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study)
- •b. The participant, if a female who is sexually active and of childbearing potential (defined as females who have experienced menarche) or a male who is sexually active, must be willing to use one of the following acceptable methods of contraception to avoid pregnancy throughout the study and for 60 days after study drug administration in such a manner that the risk of pregnancy is minimized. See Section 5.6 for the definition of childbearing potential.
- •c. The participant, if a female who has experienced menarche, must have a confirmed negative serum and urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at the Screening Visit and at the Pre-Baseline Visit (respectively).
- •d. Females must not be breastfeeding.
- •e. No clinically significant abnormality identified on the medical or laboratory evaluation. A participant with a clinical abnormality or laboratory parameters outside the lab normal reference range may be included only if the investigator considers that the finding is not clinically significant and will not introduce additional risk factors and will not interfe
排除标准
- •1. . Target Disease Exclusion
- •a. Participant has a history of cluster headache or hemiplegic migraine headache.
- •b. The participant has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- •c. The participant has a history or diagnosis of persistent aura without infarction, migrainous infarction, migraine aura-triggered seizure, chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
- •d. The participant has a confounding and clinically significant pain syndrome that may interfere with the participant’s ability to participate in this study.
- •2. Medical History and Concurrent Diseases
- •a. The participant has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.
- •b. History of suicidal behavior or the participant is at risk of self-harm or harm to others.
- •c. History of major psychiatric disorder. Participants with anxiety disorder and/or mild major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Participants must have been on a stable dose within the 3 months before the Baseline Visit.
- •d. The participant has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (DSM-5® criteria) < 2 years prior to the Screening Visit, as verified with legal representative(s) and in the opinion of the Investigator.
- •e. The participant has reported current use of, or has tested positive at the Screening visit for, drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA, methamphetamines, oxycodone, and phencyclidine).
- •f. The participant has a history of cancer.
- •g. The participant has any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or safety assessments.
- •h. The participant has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator’s opinion, likely to affect central nervous system functioning.
- •i. The participant has had recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit.
- •3. Allergies and Adverse Drug Reactions
- •a. The participant has a history of severe drug allergy or hypersensitivity or known hypersensitivity or intolerance to rimegepant or the excipients in the formulation.
- •b. The participant has a history of anaphylaxis, documented hypersensitivity reaction, or clinically significant reaction to any drug.
- •4. ECG and Laboratory Test Findings
- •a. Clinically significant abnormality identified on the medical or laboratory evaluation. A participant with a clinical abnormality or laboratory parameters outside the reference range may be included only if the investigator considers the finding not clinically significant, that it will not introduce additional risk factors, nor interfere with the study procedures.
研究者
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