Health Trials

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

ConditionMigraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine

The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.

The subject has a history or diagnosis of complications of migraine

The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Rimegepant

    Drug

    Rimegepant 75mg or 50mg (2 X 25mg) ODT

  • Placebo

    Drug

    Matching placebo 75mg or 50mg (2 X 25mg) ODT

Treatment groups

640 Participants
are divided into 2 treatment groups
Group A: Rimegepant / BHV3000Active comparator 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine

Reduction from baseline in mean number of migraine days per month

Time frame
3 months (12 weeks)

Secondary outcomes

1

Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine

Time frame
3 months (12 weeks)
2

Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.

Time frame
Weeks 1 through 4 of treatment
3

The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.

Time frame
Total score at week 12
4

Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.

Time frame
3 months (12 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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