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Tests treatment safety and results for Migraine
Official title A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
ClinicalTrials.gov ID: NCT07645924
What this study is testing
What is Elismetrep?
Elismetrep is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for migraine.
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
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1\. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent. 2. Has greater than a one-year history of migraine...
- 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...
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
You likely can't join if
- Participants are excluded from the trial if any of the following criteria apply:
- Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial. Migraine history-related
- 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...
- Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.
See the full eligibility criteria
Who can join
- 1\. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent. 2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society...
- 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...
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).
- Intrauterine device (IUD);
- Intrauterine hormone-releasing system (IUS);
- Bilateral tubal occlusion;
- Vasectomized partner;
- 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). 5\. Voluntarily agrees to participate in the study by giving written...
What rules you out
- Participants are excluded from the trial if any of the following criteria apply:
- Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial. Migraine history-related
- 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).
- Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.
- Was \>50 years old at age of first migraine onset.
- Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for...
- Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than...
- Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded...
- Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic...
- Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with...
- Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial...
- Has a history of human immunodeficiency virus disease.
- Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption. Laboratory, vital sign...
- Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.
- Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of \<30 mL/min/1.73 m2.
- Has a screening result for alanine aminotransferase or aspartate aminotransferase of \>2.0 X upper limit of normal (ULN) or total bilirubin \>1.5 X ULN at the Screening visit. Note: An isolated bilirubin \>1.5 X ULN is...
- Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) \>450 ms for males and \>470 ms for females at screening.
- Has a mean value for triplicate seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood...
- Has known history of or suspected abuse of alcohol or recreational drugs at Screening.
- Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol [THC] or cannabidiol [CBD] within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within...
- Has a positive drug screen at screening. Note:
- If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the...
- If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder)...
- 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 study participation...
- Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
- Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.
- Has a history of non-narcotic analgesic intake ≥15 days per month for
- 3 months prior to screening. Other
- Has known or suspected hypersensitivity to trial product(s) or related products.
- Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
- Has any surgery scheduled for the duration of the trial.
- Has a screening hemoglobin \<11.0 g/dL (males) or \<10.0 g/dL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia).
- Has previous participation in this trial. Participation is defined as signed informed consent.
- Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an...
- Has any other disorder, 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...
- Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 78 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 - 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 92 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.