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Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-10-18
Primary completion: 2025-05-19
Study completion finish: 2025-08-25
Study type
TREATMENT
Phase
PHASE4
Trial ID
NCT05509400
Intervention or treatment
DRUG: Rimegepant
DRUG: Placebo
DRUG: Rimegepant
Conditions
- • Migraine
Find a site
Closest Location:
Alfred Hospital
Research sites nearby
Select from list below to view details:
Alfred Hospital
Melbourne, Victoria, Australia
USC Clinical Trials Centre
Sippy Downs, Queensland, Australia
PainMedSA & CerCare Pty Ltd
Wayville, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Rimegepant
| DRUG: Rimegepant
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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. | 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). | 2 hours post-dose |
Secondary outcome
Frequently Asked Questions
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