Pediatric Migraine
Pediatric migraine is a type of recurrent headache disorder in children and adolescents, often accompanied by nausea, vomiting, and sensitivity to light or sound. With proper management, most children can significantly reduce the frequency and severity of migraines and maintain normal daily activities.
Cause: Thought to be due to a combination of genetic, neurological, and environmental factors. Triggers may include stress, lack of sleep, certain foods, dehydration, or hormonal changes.
Features: Headache (often pulsating or throbbing) lasting 1–72 hours, nausea, vomiting, photophobia (light sensitivity), phonophobia (sound sensitivity), and aura (in some cases).
Diagnosis: Based on clinical history and exclusion of other causes. Neuroimaging may be done if warning signs or unusual symptoms are present.
Treatment: Acute management - rest, hydration, over-the-counter or prescription medications (e.g., ibuprofen, triptans); Preventive strategies - lifestyle changes (regular sleep, healthy diet, stress management), and in frequent or severe cases, preventive medications
Active Trials
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TITLE: Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)
SPONSOR: AbbVie
INDICATION: Pediatric Migraine
PROTOCOL: 3110-305-002
PHASE: 3 DB
DESCRIPTION: 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, 2 to 24 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.
STATUS: Active
RECRUITING PATIENTS: Yes
RDR LOCATION: Georgia
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TITLE: Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)
SPONSOR: AbbVie
INDICATION: Migraine
PROTOCOL: 3110-306-002
PHASE: 3
DESCRIPTION: 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 long term safety and tolerability of ubrogepant 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. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 103 sites in the United States.
Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks.
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 safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
STATUS: Active
RECRUITING PATIENTS: No (rollover from 3110-305-002 study)
RDR LOCATION: Georgia
Past Trials
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TITLE: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine (OASIS PEDIATRIC [EM])
SPONSOR: Amgen Inc.
INDICATION: Pediatric Migraine
PROTOCOL: 20150125
PHASE: 3
DESCRIPTION: This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to < 12 years) and adolescents (12 to < 18 years) with EM. The study objective is to evaluate the effect of erenumab compared with placebo on the change in monthly average severity of migraine attacks from baseline to week 9 through week 12 (month 3) of the double blind treatment period.
STATUS: Active
RECRUITING PATIENTS: No
RDR LOCATION: Georgia
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TITLE: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Chronic Migraine (OASIS PEDIATRIC [CM])
SPONSOR: Amgen Inc.
INDICATION: Pediatric Migraine
PROTOCOL: 20160354
PHASE: 3
DESCRIPTION: This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to < 12 years) and adolescents (12 to < 18 years) with CM. The study objective is to evaluate the effect of erenumab compared with placebo on the change in monthly average severity of migraine attacks from baseline to week 9 through week 12 (month 3) of the double blind treatment period.
STATUS: Active
RECRUITING PATIENTS: No
RDR LOCATION: Georgia
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TITLE: A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine (REBUILD-1)
SPONSOR: Eli Lilly
INDICATION: Pediatric Migraine
PROTOCOL: I5Q-MC-CGAS
PHASE: 3
DESCRIPTION: The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
STATUS: Active
RECRUITING PATIENTS: No
RDR LOCATION: Georgia
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TITLE: A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine (REBUILD-2)
SPONSOR: Eli Lilly
INDICATION: Pediatric Migraine
PROTOCOL: I5Q-MC-CGAT
PHASE: 3
DESCRIPTION: The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
STATUS: Active
RECRUITING PATIENTS: No
RDR LOCATION: Georgia
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TITLE: Phase 3, multicenter, randomized, double-blind, group sequential, placebo-controlled study to assess efficacy and safety of rimegepant for the treatment of migraine (with or without aura) in children and adolescents ≥ 6 to < 18 years of age
SPONSOR: Pfizer (formerly Biohaven)
INDICATION: Pediatric Migraine
PROTOCOL: Pfizer C4951002 (Formerly BHV3000-311)
PHASE: 3
DESCRIPTION: This study is part of a broader pediatric development plan to evaluate rimegepant in the pediatric population. Acute treatment of migraine is a recognized condition for which previous Marketing Authorizations have been granted in adults and to a more limited extent in children 6 years of age and older. Rimegepant has received Market Authorization in the United States for the acute treatment of migraine in adults.
STATUS: Active
RECRUITING PATIENTS: No
RDR LOCATION: Georgia
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TITLE: 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
SPONSOR: Pfizer (formerly Biohaven)
INDICATION: Pediatric Migraine
PROTOCOL: Pfizer C4951003 (Formerly BHV3000-312)
PHASE: 3
DESCRIPTION: This study is part of a broader pediatric development plan to evaluate rimegepant in the pediatric population. Acute treatment of migraine is a recognized condition for which previous Marketing Authorizations have been granted in adults and to a more limited extent in children 6 years of age and older. Rimegepant has received Market Authorization in the United States for the acute treatment of migraine in adults.
STATUS: Active
RECRUITING PATIENTS: No
RDR LOCATION: Georgia