MigrainePhase 2NCT07116499
A Study of K-645 in the Treatment of Multiple Migraine Attacks
A Phase 2 study testing K-645 100 mg and K-645 10 mg in people with Migraine, run by TriGemX Bio, Inc. at 18 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, 3-period crossover study to evaluate the safety, tolerability, and efficacy of two dose levels of K-645 in the treatment of patients with acute migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- K-645 100 mg and K-645 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 18 sitesUnited States
- Study dates
- 13 Aug 2025to 18 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a male or female, age 18 to 65 years, inclusive, at the time of signing informed consent.
- Participant has greater than a one-year history of migraine with or without aura as defined by International Headache Society (IHS) criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated (refer to International Classification of Headache Disorders [ICHD] III Attachment for IHS migraine definitions) as documented in the participant's medical records from his/her treating physician and confirmed by the investigator.
- Participant has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to Screening (Visit 1).
- Meet the following requirements:
- Is a male who agrees to all of the following:
- If partner is a non-pregnant female of childbearing potential: To use an appropriate method of contraception, including a condom with spermicidal cream or jelly, from the first dose of study drug until ≥72 hours after the last dose of study drug (i.e. Period 3). A male participant who has had a vasectomy procedure must use a condom but is not required to use spermicidal cream or jelly.
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- If partner is pregnant: To use a condom from the first dose of study drug until ≥72 hours after the last dose of study drug.
- Note: Contraception/condom requirements are waived if partner is NOT of childbearing potential (i.e. is male or is a female who is post-menopausal or surgically sterile [post-hysterectomy or bilateral salpingectomy]).
- To not donate sperm from the first dose of study drug until ≥72 hours after the last dose of study drug.
- OR
- Is a female who is of non-childbearing potential defined by at least 1 of the following criteria:
- Postmenopausal defined as one of the following: a minimum of 12 months of spontaneous amenorrhea OR a minimum of 6 months of spontaneous amenorrhea with a Screening serum follicle-stimulating hormone (FSH) level >40 mIU/mL OR at least 6 weeks post-bilateral oophorectomy (with or without hysterectomy).
- Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history.
- If pre-menopausal, they must agree to not donate eggs from the first dose of study drug until 30 days after the last dose study drug.
- OR c. Is a female of reproductive potential and:
- agrees to not donate eggs from the first dose of study drug until 30 days after the last dose study drug.
- AND
- agrees to remain abstinent from heterosexual activity*,** or
- agrees to use (or have their partner use) a birth control method that is highly effective**. Acceptable methods of birth control are:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
- Progestogen-only contraception (e.g. oral, injectable, implant) associated with inhibition of ovulation
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner * 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.
- Note: Participants must agree that they will not attempt to become pregnant during the cycles of study drug administration or the menstrual cycle following the last dose of study medication.
- Voluntarily agrees to participate in the study by giving written informed consent.
- Is able to read, understand, and complete the study questionnaires and diary.
- Be willing and able to comply with the study schedule of visits and all trial procedures and restrictions.
- Be willing to use their own personal, qualified smartphone to download study-specific eDiary applications for use during the study.
Who cannot join
- Is a female who is pregnant, breast-feeding or intends to become pregnant during the planned course of the study. Note: Female participants of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.
- Migraine history-related exclusion criteria
- 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 two 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 three months prior to Screening (Visit 1).
- Has brainstem (also known as [a.k.a.] basilar-type) or hemiplegic migraine headache, or retinal migraine.
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- Was >50 years old at age of first migraine onset.
- Is taking migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to Screening (Visit 1) or anticipates any change during the study.
- Stopped preventive migraine medication(s) within 30 days prior to Screening for small molecules or 90 days for antibodies.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Dent Neurosciences Research Center
Amherst, New York, 14226
DelRicht Research - Atlanta
Atlanta, Georgia, 30329
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657
OK Clinical Research, LLC
Edmond, Oklahoma, 73034
Headache Wellness Center
Greensboro, North Carolina, 27405
Peters Medical Research
High Point, North Carolina, 27260
DM Clinical Research - Bellaire
Houston, Texas, 77081
L-MARC Research Center
Louisville, Kentucky, 40213
Clinical Research Institute
Minneapolis, Minnesota, 55402
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
Excell Research, Inc.
Oceanside, California, 92056
Collective Medical Research
Overland Park, Kansas, 66202
DelRicht Research - Prairieville
Prairieville, Louisiana, 70817
APD Clinical Research
Splendora, Texas, 77372
Clinical Research Atlanta - Stockbridge
Stockbridge, Georgia, 30281
About this study
Official title: A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Study of K-645 in the Treatment of Multiple Migraine Attacks
This is a multicenter, randomized, double-blind, placebo-controlled, 3-period crossover study to evaluate the safety, tolerability, and efficacy of two dose levels of K-645 in the treatment of patients with acute migraine.
- Conditions
- Migraine
- Being tested
- K-645 100 mg, K-645 10 mg, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-645 100 mgDrug
Single oral dose of K-645 100 mg
K-645 10 mgDrug
Single oral dose of K-645 10 mg
PlaceboDrug
Single oral dose of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| K-645 100 mg - Placebo - K-645 10 mg | Experimental | In treatment sequence 1, participants were randomized to receive single oral doses of K-645 100 mg, matching placebo, and then K-645 10 mg during Periods1, 2, and 3, respectively. Receives: Drug: K-645 100 mg; Drug: K-645 10 mg; Drug: Placebo |
| Placebo - K-645 100 mg - K-645 10 mg | Experimental | In treatment sequence 2, participants were randomized to receive single oral doses of matching placebo, K-645 100 mg, and then K-645 10 mg during Periods 1, 2, and 3, respectively. Receives: Drug: K-645 100 mg; Drug: K-645 10 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Freedom
Assessed using the number of evaluable participants that reported no pain at 2 hours post-dose. Pain was measured on a 4-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe)
Measured: 2 hours post-dose
Secondary outcomes (4)
Freedom From the Most Bothersome Symptom (MBS) (Nausea, Phonophobia, or Photophobia)
Assessed using the number of evaluable participants that reported the absence of their MBS. The MBS was measured using a binary scale (0 = absent, 1 = present)
Measured: 2 hours post-dose
Pain Relief
Assessed using the number of evaluable participants that reported a pain level of moderate or severe (responses of 2 or 3 on the 4-point Likert scale) at baseline and then reported a pain level of none or mild (response of 0 or 1).
Measured: 2 hours post-dose
Percentage of Participants Who Experienced 1 or More Treatment-emergent Adverse Events (AEs)
Measured: Up to 7 days after the last dose of study medication
Percentage of Participants Who Experienced 1 or More Treatment-emergent Serious Adverse Events (SAEs)
Serious adverse events were assessed in the Safety Analysis Set.
Measured: Up to 7 days after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start13 Aug 2025
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Why it stopped: Study stopped for futility based on an interim analysis of efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, double-blind, placebo-controlled, 3-period crossover study. In each period, participants will treat a single migraine attack. Participants will receive a different treatment in each of the three periods: placebo, K-645 dose level 1, or K-645 dose level 2.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriGemX Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116499
- Sponsor's protocol ID
- K-645 P003
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Study of K-645 in the Treatment of Multiple Migraine Attacks
- ClinicalTrials.gov ID
- NCT07116499
- Acronym / sponsor ID
- K-645 P003
- Conditions
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped for futility based on an interim analysis of efficacy.
- Enrolment
- 134 participants (actual)
- Lead sponsor
- TriGemX Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 11 Aug 2025 (actual)
- Results
- Posted 5 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled, 3-period crossover study to evaluate the safety, tolerability, and efficacy of two dose levels of K-645 in the treatment of patients with acute migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, 3-period crossover study. In each period, participants will treat a single migraine attack. Participants will receive a different treatment in each of the three periods: placebo, K-645 dose level 1, or K-645 dose level 2.
| Arm | Type | Receives |
|---|---|---|
| K-645 100 mg - Placebo - K-645 10 mg | Experimental | Drug: K-645 100 mg, Drug: K-645 10 mg, Drug: PlaceboIn treatment sequence 1, participants were randomized to receive single oral doses of K-645 100 mg, matching placebo, and then K-645 10 mg during Periods1, 2, and 3, respectively. |
| Placebo - K-645 100 mg - K-645 10 mg | Experimental | Drug: K-645 100 mg, Drug: K-645 10 mg, Drug: PlaceboIn treatment sequence 2, participants were randomized to receive single oral doses of matching placebo, K-645 100 mg, and then K-645 10 mg during Periods 1, 2, and 3, respectively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Be a male or female, age 18 to 65 years, inclusive, at the time of signing informed consent.
- Participant has greater than a one-year history of migraine with or without aura as defined by International Headache Society (IHS) criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated (refer to International Classification of Headache Disorders [ICHD] III Attachment for IHS migraine definitions) as documented in the participant's medical records from his/her treating physician and confirmed by the investigator.
- Participant has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to Screening (Visit 1).
- Meet the following requirements:
- Note: Contraception/condom requirements are waived if partner is NOT of childbearing potential (i.e. is male or is a female who is post-menopausal or surgically sterile [post-hysterectomy or bilateral salpingectomy]).
Key exclusion criteria (9 listed)
- Is a female who is pregnant, breast-feeding or intends to become pregnant during the planned course of the study. Note: Female participants of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.
- Migraine history-related exclusion criteria
- 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 two 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 three months prior to Screening (Visit 1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-645 100 mgSingle oral dose of K-645 100 mg | Drug | K-645 100 mg - Placebo - K-645 10 mg, Placebo - K-645 100 mg - K-645 10 mg |
| K-645 10 mgSingle oral dose of K-645 10 mg | Drug | K-645 100 mg - Placebo - K-645 10 mg, Placebo - K-645 100 mg - K-645 10 mg |
| PlaceboSingle oral dose of matching placebo | Drug | K-645 100 mg - Placebo - K-645 10 mg, Placebo - K-645 100 mg - K-645 10 mg |
Primary outcome
Pain Freedom
Time frame: 2 hours post-dose
Assessed using the number of evaluable participants that reported no pain at 2 hours post-dose. Pain was measured on a 4-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe)
4 secondary outcomes
Freedom From the Most Bothersome Symptom (MBS) (Nausea, Phonophobia, or Photophobia)
Time frame: 2 hours post-dose
Pain Relief
Time frame: 2 hours post-dose
Percentage of Participants Who Experienced 1 or More Treatment-emergent Adverse Events (AEs)
Time frame: Up to 7 days after the last dose of study medication
Percentage of Participants Who Experienced 1 or More Treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to 7 days after the last dose of study medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K-645 100 mg and K-645 10 mg in people with Migraine, run by TriGemX Bio, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Freedom (time frame: 2 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.