Tests rimegepant to prevent migraine in children and teens
Compares rimegepant with placebo to prevent migraine in children and adolescents aged 6 to 17.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Key facts
- Where
- Avellino, Bari, Brescia, Florence, Genoa, Latina, Milan, Padova, Pavia, Pisa, and Rome, ItalySee the 13 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT05156398, who can take part
Where in Italy
- AORN San Giuseppe Moscati AvellinoAvellino, ItalyTaking people
- Azienda Sanitaria Locale Della Provincia Di BariBari, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyTaking people
- IRCCS Istituto Giannina GasliniGenoa, ItalyTaking people
- Università La Sapienza - Centro Ambulatorio Cefalee, I.C.O.T.Latina, ItalyTaking people
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Azienda Ospedaliera di PadovaPadova, ItalyTaking people
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Irccs San Raffaele Roma S.r.l.Rome, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT05156398EU 2024-512382-13-00
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Subject has at least a 6 month history of migraine (with or without aura) and including the following:; 14 or less headache days per month during the 3 month period prior to the Screening Visit; 6 or more migraine days during the Observation Period; 14 or less headache days during the Observation Period; 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; Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches; Migraine attacks, on average, lasting 4 - 72 hours if untreated; 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.
Exclusion: The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit; 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; Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine; The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study; History of suicidal behavior or the subject is at risk of self-harm or harm to others; History of major psychiatric disorder; The subject has a current diagnosis or history of substance abuse; 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; The subject has a history or diagnosis of complications of migraine.