Brief Summary
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
Brief Title
Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Detailed Description
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Migraine
Eligibility Criteria
Inclusion Criteria:
* Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
* Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
* 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol).
* Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase.
* Subjects must be able to distinguish migraine attacks from tension/cluster headaches.
* Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
* Triptan unsuitable
Exclusion Criteria:
-Target Disease Exclusion:
1. History of cluster headache, basilar migraine, or hemiplegic migraine
2. Current medication overuse headaches
3. Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
4. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\])
5. Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy
* Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
* Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
* 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol).
* Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase.
* Subjects must be able to distinguish migraine attacks from tension/cluster headaches.
* Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
* Triptan unsuitable
Exclusion Criteria:
-Target Disease Exclusion:
1. History of cluster headache, basilar migraine, or hemiplegic migraine
2. Current medication overuse headaches
3. Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
4. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\])
5. Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy
Inclusion Criteria
Inclusion Criteria:
* Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
* Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
* 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol).
* Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase.
* Subjects must be able to distinguish migraine attacks from tension/cluster headaches.
* Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
* Triptan unsuitable
* Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
* Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
* 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol).
* Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase.
* Subjects must be able to distinguish migraine attacks from tension/cluster headaches.
* Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
* Triptan unsuitable
Gender
All
Gender Based
false
Keywords
Migraine
Acute Migraine
Headache
Acute treatment of Migraine in adults unsuitable for triptans
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05509400
Org Class
Industry
Org Full Name
Pfizer
Org Study Id
BHV3000-406
Overall Status
Active, not recruiting
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
BHV3000-406 (C4951004): A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Primary Outcomes
Outcome Description
Migraine headache pain relief will be assessed using the percentage of subjects with a headache pain intensity of none or mild. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).
Outcome Measure
Compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase.
Outcome Time Frame
2 hours post-dose
Secondary Ids
Secondary Id
C4951004
Secondary Id
2022-001175-14
Secondary Id
2024-513269-37-00
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jelena Pavlovic
Investigator Email
jpavlovi@montefiore.org