Acute Treatment of Vestibular Migraine by Rimegepant
ConditionVestibular Migraine
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorWensheng Qu
About this trial
To evaluate whether rimegepant improves acute vestibular symptoms and accompanying discomforts in patients with vestibular migraine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-60 years, male or female.
Diagnosis of vestibular migraine according to the Bárány Society criteria.
≥4 episodes of characteristic vestibular symptoms in the past year, each of moderate to severe intensity and lasting >2 hours (without intervention).
Signed informed consent obtained from the participant.
Disqualifiers
Presence of other disorders causing acute vestibular symptoms (e.g., Ménière's disease, otitis media).
Coexisting non-vertiginous dizziness (e.g., dizziness due to panic disorder), unless the patient can clearly distinguish these episodes from vestibular-migraine attacks.
Severe hepatic dysfunction (ALT and/or AST >3× upper limit of normal) or renal impairment (creatinine clearance <30 mL/min).
Severe cardiovascular or cerebrovascular disease.
Trial design
Design model
Crossover
Treatments tested in this trial
First dose rimegepant, second dose placebo
DrugFirst dose rimegepant, second dose placebo
First dose placebo, second dose rimegepant
DrugFirst dose placebo, second dose rimegepant
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: First dose rimegepant, second dose placeboExperimental treatment 2 interventions
Group B: First dose placebo, second dose rimegepantExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Vertigo symptom relief rate
After 2 hours of medication, vertigo symptoms improved from moderate or severe to mild or no vertigo.
Time frame
2 hours after medicationSecondary outcomes
1
headache relief rate
After 2 hours of medication, headache symptoms improved from moderate or severe to mild or no vertigo
Time frame
2 hours after medication2
relief rate of nausea and vomiting
After 2 hours of medication, complete resolution rate of nausea and vomiting
Time frame
2 hours after medication3
relief rate of photophobia and phonophobia
After 2 hours of medication, complete resolution rate of photophobia and phonophobia
Time frame
2 hours after medicationOther outcomes
1
daily activities
Time to resume normal daily activities
Time frame
day 1 after medication2
Rescue medication
Use rate of rescue medication
Time frame
within the first day after medication3
relief rate of vertigo symptoms
After 2 hours of medication, complete resolution rate of vertigo symptoms
Time frame
2 hours after medicationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wensheng Qu
Lead sponsor
Tongji Hospital
Sponsor institution
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Wuhan No.1 Hospital
Collaborator
Wuhan Puren Hospital
Collaborator
Xiangyang Central Hospital
Collaborator
Xinyang Central Hospital
Collaborator
Source ClinicalTrials.gov