A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
Recruiting
Phase 3Interventional Study
Acute Migraine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,000 (estimated)
Sponsor
Kallyope Inc. · Industry
Who this trial is looking for
This trial is looking for people who have finished a previous trial using elismetrep for treating migraines and want to continue assessing its safety. Participants will need to take part in questionnaires and use an app on their smartphone.
Are You a Good Fit for This Trial?
You may be able to join if
I have completed a previous trial using elismetrep.
I can read and understand study information.
I agree to participate in the trial.
I will comply with the study visit schedule.
I have been compliant with daily check-ins in the previous trial.
I will use my own smartphone to download necessary apps.
I am a female of reproductive potential and agree to use effective birth control.
You may not be able to join if
I am pregnant, breastfeeding, or planning to become pregnant.
I have had a change in my medical condition that affects my eligibility.
I am at risk of self-harm or harm to others.
I have experienced a serious adverse event in my previous trial.
I have an ongoing adverse event from my last trial visit.
I have a major surgery planned during this trial.
I have previously participated in this trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins'…
Inclusion Criteria:
1. Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins' in the base study and completed the 2-hour and 4-hour post-dose assessments in the eDiary;
2. Participant voluntarily agrees to participate in the study by giving written informed consent;
3. Participant is able to read, understand, and complete the study questionnaires and diary;
4. Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;
5. Participant is willing to use his/her own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration of the study;
6. For females of reproductive potential (as determined in the base study), continues to agree to remain abstinent from heterosexual activity or a. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the EoS visit.
Acceptable methods of birth control are:
i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral; injectable; implantable; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence\*; progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).
* Abstinence can be used as the sole method of contraception if it is in line with the participant's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.
Exclusion Criteria:
1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study);
2. Has, at the time of the base study EoS/Visit 3, had any change in medical history or a laboratory finding since screening in the acute treatment study that in the opinion of the investigator renders the participant unsuitable for this study (e.g., development of a finding that would have precluded participation in the base acute treatment study);
3. Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS) taken during the base study E0S/Visit 3, or of harm to others in the opinion of the investigator. Participants must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in 'since last version' version of the C-SSRS;
4. Participant is currently in violation of study requirements for prohibited and permissible concomitant medications (not already specified in other criteria or is anticipated to violate these requirements during trial participation) as assessed for the base study E0S/Visit 3;
5. Has any major surgery scheduled for the duration of the trial;
6. Has any other unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with the interpretation of efficacy and/or safety results;
7. At Visit 1, has an open/ongoing adverse event from the base study EoS visit;
8. Experienced a serious adverse event in the base study;
9. Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.
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