NotablePrimary completion pushed from Aug 19, 2028 to Feb 26, 2030Show 6 more changesShow less
Enrollment increased: 200 → 636 participants
Study completion pushed from Oct 13, 2029 to Apr 22, 2031
Eligibility criteria expanded, about 11 words
Secondary endpoints revised (8)
Study sites revised (102)
Publications: details revised at 1 of 1 entry
NotablePrimary completion pushed from Oct 8, 2026 to Aug 19, 2028
Enrollment closed, study ongoing
Study completion pushed from Dec 2, 2027 to Oct 13, 2029
Study sites revised (102)
v35
MinorStudy sites: 103 to 102v34
MinorTrial sites reduced: 108 → 103 locationsv33
MinorStudy sites: 107 to 108v32
MinorTrial sites expanded: 48 → 107 locationsv31
MinorTrial sites reduced: 107 → 48 locationsv30
MinorStudy sites: 109 to 107v29
MinorStudy sites: 106 to 109v28
MinorStudy sites: 104 to 106v27
MinorStudy sites: 102 to 104v26
MinorStudy sites: 100 to 102v25
MinorStudy sites: 98 to 100v24
MinorStudy sites: 97 to 98v23
MinorStudy sites: 92 to 97v22
MinorSite details revised at 2 of 92 sitesv21
MinorStudy sites: 88 to 92v20
MinorStudy sites: 86 to 88v19
MinorStudy sites: 85 to 86v18
MinorStudy sites revised (85)v17
MinorStudy sites: 80 to 85v16
MinorStudy sites: 79 to 80v15
MinorStudy sites: 72 to 79v14
MinorStudy sites: 70 to 72v13
MinorStudy sites: 67 to 70v12
MinorStudy sites: 63 to 67v11
MinorStudy sites: 42 to 63
Primary completion date: Oct 21, 2026 to Oct 8, 2026
Study completion date: Dec 15, 2027 to Dec 2, 2027
v10
MinorStudy sites: 20 to 42v9
MinorStudy sites: 12 to 20v8
Re-verified, no change to tracked fieldsv7
MinorStudy sites: 10 to 12v6
MinorStudy sites: 8 to 10v5
MinorStart date: Dec 1, 2024 to Nov 15, 2024
Site details revised at 1 of 8 sites
v4
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 6 to 8
Primary completion date: Oct 8, 2026 to Oct 21, 2026
Study completion date: Dec 2, 2027 to Dec 15, 2027
v3
NotablePrimary completion date: Dec 6, 2027 to Oct 8, 2026
Study sites: 0 to 6
Study completion date: May 11, 2028 to Dec 2, 2027
Start date: Dec 6, 2024 to Dec 1, 2024
v2
Study First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks.
Rimegepant is a tablet that disintegrates when you put it on or under your tongue.
The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours
In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day.
Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months.
In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period.
Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at the study clinic visits. Participants will have to complete a daily diary to record the migraine attacks.