A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
ConditionMigraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKallyope Inc.
About this trial
This is a double-blind, randomized, multicenter, outpatient evaluation of the efficacy, safety, and tolerability of elismetrep, as compared with placebo, in the acute treatment of migraine.
Eligibility criteria
Qualifiers
A minimum of 12 months of spontaneous amenorrhea or
A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level > 40 mIU/mL or
At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
Disqualifiers
Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial.
Has difficulty distinguishing his/her migraine attacks from tension-type headaches.
Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.
Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).
Trial design
Treatments tested in this trial
- Elismetrep
- Placebo
Treatment groups
1,800 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov