A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
概览
- 阶段
- 3 期
- 干预措施
- Ubrogepant
- 疾病 / 适应症
- Migraine
- 发起方
- AbbVie
- 入组人数
- 1059
- 试验地点
- 244
- 主要终点
- Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents.
Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment.
For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, at least 2 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
研究者
入排标准
入选标准
- •A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD-3) for at least 6 months.
- •By history, the participant's migraines typically last between 3 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.
- •History of 1 to 14 migraine attacks per month with moderate to severe headache in each of the 2 months prior to screening (Visit 1).
- •Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the acute treatment of migraine.
- •For main study participants, treatment of a qualifying migraine with single-blind placebo during the screening period and completion of 2-hour headache pain assessment.
- •Weight is ≥ 20 kg (44 pounds) and \< 135 kg (298 pounds)
- •Per investigator judgment, participant is able to swallow or can learn to swallow study intervention.
- •The participant is able to understand and complete the study questionnaires and eDiary. Participants who need assistance with reading the assessments may be assisted by a parent or guardian.
排除标准
- •Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
- •In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, or other significant neurological disorders other than migraine.
- •History of malignancy in the 5 years prior to Visit
- •History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of the study intervention.
- •Significant risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others; participants must be excluded if they report suicidal ideation with intent, with or without a plan, (ie, Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidal behavior in the last 6 months prior to Visit 1 or Visit 2 assessments.
- •At Visit 1, current alcohol or drug abuse or dependence per investigator's judgment.
- •For main study participants, no headache at the 2-hour post dose assessment after taking single-blind placebo for a qualifying migraine during screening period (ie, placebo responder).
- •A current diagnosis of chronic migraine as defined by ICHD-3
- •Participants who overuse medication for migraine defined as use of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month or any combination of triptans, ergots, or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 10 days/month in the 3 months prior to Visit 1 per investigator's judgment.
- •Difficulty distinguishing migraine headache from tension-type or other headaches.
研究组 & 干预措施
Main Study: Adolescents Ubrogepant High Dose
Participants aged 12 to 17 will receive oral tablets of ubrogepant high dose or qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
干预措施: Ubrogepant
PK Cohort: Ubrogepant Dose A
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
干预措施: Ubrogepant
PK Cohort: Ubrogepant Dose B
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
干预措施: Ubrogepant
Main Study: Children Ubrogepant Low Dose
Participants aged 6 to 11 (after dose selection) will receive oral tablets of low dose ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
干预措施: Ubrogepant
Main Study: Children Ubrogepant High Dose
Participants aged 6 to 11 (after dose selection) will receive oral tablets of high dose ubrogepant Dose B for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
干预措施: Ubrogepant
Main Study: Children Ubrogepant Placebo
Participants aged 6 to 11 (after dose selection) will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
干预措施: Placebo-Matching Ubrogepant
Main Study: Adolescents Ubrogepant Low Dose
Participants aged 12 to 17 will receive oral tablets of ubrogepant low dose for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
干预措施: Ubrogepant
Main Study: Adolescents Ubrogepant Placebo
Participants aged 12 to 17 will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
干预措施: Placebo-Matching Ubrogepant
结局指标
主要结局
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
时间窗: 2 hours after initial dose
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
次要结局
- Percentage of participants that used rescue medication (including a second dose of study intervention) within 24 hours after the initial dose in pediatric participants aged 6 to 17 years(24 hours after initial dose)
- Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 6 to 17 years(Baseline (Predose) to 2 hours after initial dose)
- Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 11 years(2 hours after initial dose)
- Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years(2 hours after initial dose)
- Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years(2 hours after initial dose)
- Percentage of patients with suicidal ideation or suicidal behavior(Up to 6 months)
- Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 12 to 17 years(Baseline (Predose) to 2 hours after initial dose)
- Percentage of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed in pediatric participants aged 6 to 17 years(Up to 6 months)
- Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements in pediatric participants aged 6 to 17 years(Up to 6 months)
- Percentage of participants with Pain Relief at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years(2 hours after initial dose)
- Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose in pediatric participants aged 6 to 17 years(2 to 24 hours after initial dose)
- Percentage of Participants With the Absence of Nausea at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years(2 hours after initial dose)
- Number of Participants with Adverse Events (AE)(Up to 6 months)
- Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years(2 hours after initial dose)
- Change From Baseline in Electrocardiograms (ECGs) in pediatric participants aged 6 to 17 years(Up to 6 months)