Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age
Interventional
Phase 3
Pfizer (Voir sur ClinicalTrials)
février 2022
avril 2027
09 octobre 2024
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo
as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years
with episodic migraine.
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 01:30:16 | 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 | |||||
| Centre Hospitalier Universitaire de Montpellier - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU Gui de Chauliac - 34090 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Hopital des Enfants - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Subject has at least a 6 month history of migraine (with or without aura) and
including the following:
1. 14 or less headache days per month during the 3 month period prior to the
Screening Visit
2. 6 or more migraine days during the Observation Period
3. 14 or less headache days during the Observation Period
4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of
>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50)
disruption in daily activities, as assessed at the Baseline (Randomization)
Visit
5. Ability to verbally distinguish migraine attacks from tension/cluster or other
types of headaches
6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
7. Subjects on prophylactic migraine medication are permitted to remain on therapy
if the dose has been stable for at least 3 months (12 weeks) prior to the
Screening Phase, and the dose is not expected to change during the course of
the study. 2) Male and female subjects ≥ 6 to <18 years; subjects must be less
than 18 at the time of signing assent / consent.
3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at
the Screening Visit.
1. Subject has at least a 6 month history of migraine (with or without aura) and
including the following:
1. 14 or less headache days per month during the 3 month period prior to the
Screening Visit
2. 6 or more migraine days during the Observation Period
3. 14 or less headache days during the Observation Period
4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of
>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50)
disruption in daily activities, as assessed at the Baseline (Randomization)
Visit
5. Ability to verbally distinguish migraine attacks from tension/cluster or other
types of headaches
6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
7. Subjects on prophylactic migraine medication are permitted to remain on therapy
if the dose has been stable for at least 3 months (12 weeks) prior to the
Screening Phase, and the dose is not expected to change during the course of
the study. 2) Male and female subjects ≥ 6 to <18 years; subjects must be less
than 18 at the time of signing assent / consent.
3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at
the Screening Visit.
1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic
migraine
2. The subject has a continuous migraine (defined as an unrelenting headache) within 1
month prior to Screening Visit.
3. The subject has a history or diagnosis of complications of migraine
4. The subject has a confounding and clinically significant pain syndrome that may
interfere with the subject's ability to participate in this study.
5. The subject has any current psychiatric condition that is uncontrolled and/or
untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a
lifetime history of psychosis and/or mania are excluded.
6. History of suicidal behavior or the subject is at risk of self-harm or harm to
others.
7. History of major psychiatric disorder.
8. The subject has a current diagnosis or history of substance abuse
9. The subject has a history of moderate or severe head trauma or other neurological
disorder (including seizure disorder) or systemic medical disease that is, in the
investigator's opinion, likely to affect central nervous system functioning.