Informations générales (source: ClinicalTrials.gov)
A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age. (ATO EM PEDS)
Interventional
Phase 3
AbbVie (Voir sur ClinicalTrials)
mai 2023
mai 2028
05 avril 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 pediatric participants.
The main goal of the study is to evaluate the safety and efficacy (how well treatment
works) of a low-dose and high-dose of atogepant in pediatric participants between the
ages of 6 and 17.
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 episodic migraine. This is a Phase 3, randomized,
double-blind study of atogepant in participants with a history of episodic migraine with
an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6
different groups. Participants between the ages of 12 and 17 will be randomized to
receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants
between the ages of 6 and 11 will also be randomized to receive placebo, low-dose
atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used
in participants between the ages of 6 and 11 will be determined after the PK substudy is
complete. Around 450 participants will be enrolled in approximately 100 sites worldwide.
Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by
mouth once a day. At the end of Week 12, participants will either undergo a follow-up
visit 4 weeks after last study treatment or join an extension study where they can
continue to receive atogepant for another 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 | 29/03/2024 01:30:44 | 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# 248833 - 80054 - Amiens CEDEX 1 - Somme - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - Hôpital des enfants /ID# 247553 - 31059 - Toulouse CEDEX 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
- History of episodic migraine with or without aura consistent with a diagnosis
according to the International Classification of Headache Disorders (ICHD) -3 (2018)
for at least 6 months.
- Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day
baseline period per eDiary.
- To be eligible for the PK substudy, participants must be 6 to 11 years of age
(inclusive), with a history of migraine (consistent with a diagnosis according to
the ICHD-3 [2018]) and per investigator judgment is appropriate to receive
preventive treatment for migraine.
- Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
- History of episodic migraine with or without aura consistent with a diagnosis
according to the International Classification of Headache Disorders (ICHD) -3 (2018)
for at least 6 months.
- Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day
baseline period per eDiary.
- To be eligible for the PK substudy, participants must be 6 to 11 years of age
(inclusive), with a history of migraine (consistent with a diagnosis according to
the ICHD-3 [2018]) and per investigator judgment is appropriate to receive
preventive treatment for migraine.
- History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as
defined by ICHD-3 (2018).
- Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
- 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).