Informations générales (source: ClinicalTrials.gov)
A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Atogepant in Pediatric Subjects 6 to 17 Years of Age With Migraine
Interventional
Phase 3
AbbVie (Voir sur ClinicalTrials)
juin 2023
avril 2032
14 septembre 2025
A migraine is a moderate to severe headache on one side of the head. A migraine attack is
a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light
and sound, or other symptoms. A number of treatments are available for adults with
migraine but there are limited approved treatments available for participants less than
18 years of age. The main goal of the study is to evaluate the long-term safety and
tolerability of atogepant in pediatric participants between the ages of 6 and 17 with
migraine.
Atogepant is a medicine currently approved to treat adults with migraine (0 to 14
migraine days per month) and is being studied in pediatric participants between the ages
of 6 and 17 with a history of migraine. This is a Phase 3, open-label study of atogepant
in participants with a history of migraine. Participants must have completed
participation in another study of atogepant (lead-in study). Participants must have 4 to
14 migraine days and less than 15 headache days for episodic migraine, and >= 15 headache
days and >= 8 migraine days for chronic migraine in the 4-week screening electronic diary
(eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study
at approximately 100 sites worldwide.
Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and
17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and
11 will receive an atogepant dose determined in the lead-in study for 52 Weeks.
There may be a bigger responsibility for participants in this study. Participants will
attend regular visits during the study at a hospital or clinic. The effects of treatment
will be checked by medical assessments, blood tests, checking for side effects, and
completing questionnaires.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Julien NGO | 01/10/2025 08:40:06 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Amiens-Picardie Site Sud /ID# 251377 - 80054 - Amiens CEDEX 1 - Somme - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - Hôpital des enfants /ID# 251201 - 31059 - Toulouse CEDEX 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participants must be between 6 and 17 years of age (inclusive), with a history of
episodic (ages 6 to 17) or chronic (ages 12 to 17) migraine.
- The participant must have completed the lead-in Study M21-201, or the
pharmacokinetic (PK) substudy in Study M21-201, or the lead-in Study M23-712.
- Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
- A history of migraine with or without aura consistent with a diagnosis according to
the International Classification of Headache Disorders, 3rd Edition (ICHD-3; 2018)
for at least 6 months.
- Participants must be between 6 and 17 years of age (inclusive), with a history of
episodic (ages 6 to 17) or chronic (ages 12 to 17) migraine.
- The participant must have completed the lead-in Study M21-201, or the
pharmacokinetic (PK) substudy in Study M21-201, or the lead-in Study M23-712.
- Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
- A history of migraine with or without aura consistent with a diagnosis according to
the International Classification of Headache Disorders, 3rd Edition (ICHD-3; 2018)
for at least 6 months.
- Have a current diagnosis of new daily persistent headache, trigeminal autonomic
cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by
ICHD-3 (2018).
- Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic,
gastrointestinal, cardiovascular, or neurologic disease.