Acute Migraine study: Elismetrep
Official title A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
ClinicalTrials.gov ID: NCT07674654
What this study is testing
What is Elismetrep?
Elismetrep is an investigational oral medicine being studied for the acute treatment of migraine attacks.
Also referred to as K-304.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe and well tolerated elismetrep is when used intermittently to treat migraine attacks.
- Who it's for
- Adults who have migraine and are willing to try a new treatment.
- What's involved
- Participants will take elismetrep during migraine attacks and may have follow‑up visits and tests to monitor safety.
- Time commitment
- The study lasts several months and requires regular clinic visits and safety monitoring.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant completing an acute treatment trial of elismetrep (Study K-304 P003
- Participant voluntarily agrees to participate in the study by giving written informed consent;
- Participant is able to read, understand, and complete the study questionnaires and diary;
- Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;
- Participant is willing to use his/her own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration...
You likely can't join if
- Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study.
- 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...
- Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS)...
- Participant is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already...
- Has any major surgery scheduled for the duration of the trial;
- Has any other unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize...
See the full eligibility criteria
- 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...
- Participant voluntarily agrees to participate in the study by giving written informed consent;
- Participant is able to read, understand, and complete the study questionnaires and diary;
- Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;
- 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;
- For females of reproductive potential (as determined in the base study), continues to agree to remain abstinent from heterosexual activity or a.
- 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.
- Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study.
- 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...
- 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...
- Participant is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements...
- Has any major surgery scheduled for the duration of the trial;
- 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...
- At Visit 1, has an open/ongoing adverse event from the base study EoS visit;
- Experienced a serious adverse event in the base study;
- Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Chandler, Arizona, United States
- Little Rock, Arkansas, United States
- Colton, California, United States
- Culver City, California, United States
- Encino, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Mission Viejo, California, United States
- Oceanside, California, United States
- Pomona, California, United States
- Riverside, California, United States
- San Diego, California, United States
- Sherman Oaks, California, United States
- Spring Valley, California, United States
- Walnut Creek, California, United States
- West Covina, California, United States
- West Hills, California, United States
- Centennial, Colorado, United States
+ 76 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Mobile, Alabama, United States; Chandler, Arizona, United States; Little Rock, Arkansas, United States; Colton, California, United States; Culver City, California, United States and 90 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.