NL-OMON54273招募中3 期
Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1 - H8H-MC-LAHV (PIONEER-PEDS1)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Eli Lilly
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
入选标准
- •Type of Patient and Disease Characteristics
- •[1] Patient is at least 6 and less than 18 years of age at Screening (Visit 1).
- •[2] Patient must have a minimum body weight of 15 kg.
- •[3] Patient has a history of migraine with or without aura as defined by
- •International Headache Society International Classification of Headache
- •Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or
- •1.2.1 and meets the following criteria:
- •- History of migraine attacks for more than 6 months
- •- Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per
- •month in the 2 months prior to Screening Visit
- •- Duration of a typical untreated migraine attack (excluding sleep) is greater
- •equal to*3 hours
- •- Patient has not, by history, experienced satisfactory response with a previous
- •migraine therapy, in the opinion of the investigator.
- •[4] Patient must be able to swallow a tablet.
- •[5] For patients taking migraine preventive medication, treatment regimen is
- •stable and has been taken for at least 3 months prior to Visit 1.
- •Informed Consent and Patient Agreements
- •[6] The patient and patient*s parent or guardian must understand the nature of
- •study. The patient*s parent or guardian must sign an ICF, and the patient must
- •sign an informed assent document as required by local regulations.
- •[7] The patient and patient*s parent or guardian are reliable and willing to
- •themselves available for the duration of the study and are willing to follow
- •study procedures.
- •[8] Patient is male or female; if female, must agree to abide by the following
- •- Females of childbearing potential (started menses, to include any duration or
- •amount of spotting) must agree to use a highly effective method of contraception
- •(that is, one with less than 1% failure rate) such as
- •o combination oral contraceptives
- •o implanted/injected contraceptives
- •o intrauterine devices, or
- •o sterile partner until 30 days after the last dose of study medication.
- •- Females of childbearing potential who are abstinent (if this is complete
- •abstinence,
- •as their preferred and usual lifestyle) or in a same-sex relationship (as part
- •preferred and usual lifestyle) must agree to either remain abstinent or stay in
- •same-sex relationship without sexual relationships with males. Periodic
- •(for example, calendar, ovulation, symptothermal, and postovulation methods),
- •declaration of abstinence just for the duration of a trial, and withdrawal are
- •acceptable methods of contraception.
- •[9] The patient and patient*s parent or guardian must agree not to post any
- •personal medical data related to the study or information related to the study
- •on any website or social media site until notification that the study has been
- •completed. Examples of these sites include
- •- Snapchat
- •- Instagram, and
- •- Google+.
排除标准
- •Medical Conditions
- •[10] Patient has a history or clinical evidence of congenital heart disease,
- •or confirmed.
- •[11] ECG showing abnormalities compatible with acute cardiovascular events,
- •serious cardiovascular disease risk, or both.
- •[12] Within 6 months of screening, patient had
- •- myocardial infarction
- •- unstable angina
- •- percutaneous coronary intervention, and
- •- coronary artery bypass graft.
- •[13] Patient has planned cardiovascular surgery or percutaneous coronary
- •angioplasty, or has a history of stroke.
- •[14] Patient has any liver tests outside the normal range at screening that are
- •significant. Alanine aminotransferase (ALT) greater than 2x upper limit of
- •(ULN), or total bilirubin level (TBL) greater than 1.5x ULN, or alkaline
- •phosphatase
- •(ALP) greater than 2x ULN must be discussed and judged not clinically
- •significant by
- •Lilly Medical prior to enrollment.
- •NOTE: Patients with TBL at least 1.5x ULN are not excluded if they meet all of
- •following criteria for Gilbert syndrome:
- •*- Bilirubin is predominantly indirect (unconjugated) at Screening (direct
- •bilirubin within normal limits)
- •* - Absence of liver disease
- •* - ALT, aspartate aminotransferase (AST), and ALP no greater than 1x ULN at
- •screening, and
- •* Hemoglobin not significantly decreased at screening.
- •[15] Patient has, in the judgement of the investigator, a psychiatric disorder
- •defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th
- •Edition, that would interfere with adherence to study requirements or safe
- •participation in the trial. This includes a current or historical diagnosis of a
- •substance use disorder.
- •[16] Patient is, in the judgment of the investigator, actively suicidal and
- •deemed to be at significant risk for suicide.
- •[17] At Screening:
- •- patient has answered *yes* to either Question 4 or Question 5 on the *Suicidal
- •Ideation* portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) or has
- •answered *yes* to any of the suicide-related behaviors on the *suicidal
- •portion of the C-SSRS, and
- •- the ideation or behavior occurred within the past month.
- •[18] Patient is pregnant or breastfeeding.
- •[19] Patient has, in the judgment of the investigator, an acute, serious, or
- •medical condition or a history or presence of any other medical illness that
- •would preclude study participation.
- •Prior and Concomitant Therapy/Substances of Abuse
- •[20] Patient has used opioids or barbiturate-containing analgesic more than 3
- •per month for the treatment of pain in more than 2 of the past 6 months.
- •[21] Patient has known allergies to lasmiditan, related compounds, or any
- •components of the formulation.
- •[22] Patient has a positive urine drug screen for any substances of abuse.
研究者
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