A Study to Assess 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 safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 subject'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 study. Note: Female participants of child-bearing potential must have a negative serum pregnancy test (β-human chorionic gonadotropin) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.
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
Design model
Parallel
Treatments tested in this trial
Elismetrep
DrugAdministered orally
Placebo
DrugAdministered orally
Treatment groups
1,500 Participants
are divided into 3 treatment groupsGroup A: Elismetrep 10 mgExperimental treatment 1 intervention
Group B: Elismetrep 20 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain freedom at 2 hours post-dose
Percentage of subjects who report no pain at 2 hours post-dose. Pain will be measured on a 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Time frame
Two hours post-dose2
Freedom from most bothersome symptoms (MBS) at 2 hours post-dose
Percentage of subjects who report absence of their MBS (nausea, phonophobia, or photophobia) at 2 hours post-dose. MBS will be measured using a binary scale (0=absent, 1=present).
Time frame
Two hours post-doseSecondary outcomes
1
Pain relief at 2 hours post-dose
Percentage of subjects who report a pain level of moderate of severe (responses of 2 or 3 on the 4-point Likert scale) at baseline and then report a pain level of none or mild (responses of 0 or 1 on the 4-point Likert scale) at 2 hours post-dose.
Time frame
Two hours post-dose2
Sustained pain freedom from 2 to 24 hours post-dose
Percentage of subjects who do not use any rescue medication, do not experience any headache pain through the time period of interest, and do not have missing pain data at 2 or 24 hours post-dose.
Time frame
From 2 to 24 hours post-dose3
Sustained pain freedom from 2 to 48 hours post-dose
Percentage of subjects who do not use any rescue medication, do not experience any headache pain through the time period of interest, and do not have missing pain data at 2, 24, or 48 hours post-dose.
Time frame
From 2 to 48 hours post-dose4
Sustained pain relief from 2 to 24 hours post-dose
Percentage of subjects who do not use any rescue medications, do not experience any moderate or severe headache pain through the time period of interest, and do not have missing pain data at 2 or 24 hours post-dose.
Time frame
From 2 to 24 hours post-doseSponsors and contacts
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Source ClinicalTrials.gov