Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Migraine
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Acute Migraine, Headache, Acute treatment of Migraine in adults unsuitable for triptans
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:
- History of cluster headache, basilar migraine, or hemiplegic migraine
- Current medication overuse headaches
- Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
- Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS])
- 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
Sites / Locations
- Clinical Research InstituteRecruiting
- Ki Health Partners LLC, dba New England Institute for Clinical ResearchRecruiting
- Complete Health Research
- Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
- Wr-Msra, LlcRecruiting
- AppleMed Research Group, LLC
- Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research UnitRecruiting
- WR-Mount Vernon Clinical Research, LLCRecruiting
- Collective Medical ResearchRecruiting
- DelRicht ResearchRecruiting
- DelRicht ResearchRecruiting
- Boston Clinical TrialsRecruiting
- Community Clinical Research Network IncRecruiting
- StudyMetrix Research
- Clinvest Research, LLCRecruiting
- Clinvest Research, LLCRecruiting
- Montefiore Medical Center
- New York Neurology Associates
- Headache Wellness Center, PCRecruiting
- Red Star Research, LLCRecruiting
- DM Clinical ResearchRecruiting
- Northwest Clinical Research CenterRecruiting
- USC Clinical Trials CentreRecruiting
- CerCare Pty Ltd
- Alfred Hospital
- Cabinet Privé Dr. Simona Sava
- GZA Ziekenhuizen
- UZ Brussel
- UZ Gent
- Jessa Ziekenhuis
- Cabinet Privé Dr. Simona Sava
- NeuPath Centre for Pain and Spine
- Clinique Neuro-Lévis
- Alpha Recherche CliniqueRecruiting
- Alpha Recherche CliniqueRecruiting
- Danish Headache CenterRecruiting
- Helsinki Headache CenterRecruiting
- Helsinki Headache Center
- Terveystalo RuoholahtiRecruiting
- Terveystalo Pulssi
- CHU Nice Hopital Cimiez
- Kopfschmerzzentrum Frankfurt
- Helios DKD Hospital Wiesbaden
- Twoja Przychodnia Nowosolskie Centrum Medyczne
- Concept MedicaRecruiting
- Instytut Zdrowia
- Praktyka LekarskaRecruiting
- Centrum Leczenia Bolu dr n med Lukasz Kmieciak
- University Hospital Marqués de Valdecilla
- University Hospital Marqués de ValdecillaRecruiting
- Hospital Universitario Vall d'Hebron
- Hospital Universitario La PazRecruiting
- Virgen del Rocio University Hospital
- Hospital Clínico Universitario de Valencia
- CTC Solna
- CTC Uppsala
- Skåneuro Privatmottagning
- CTC AB
- Hälsoklustret
- Akardo MedSite
- CTC Uppsala
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Rimegepant
Placebo
Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT) Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe)
Placebo - Double-blind (DB) Phase: One dose of matching placebo Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine