K-645 for Migraine

No longer recruiting at 17 trial locations

Overseen By Clinical Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kallyope Inc.

Must not be taking: Migraine prophylactics

Disqualifiers: Pregnancy, Breast-feeding, Brainstem migraine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called K-645, a potential drug for acute migraines. The study aims to determine the safety and effectiveness of K-645 in reducing migraine symptoms. Participants will receive varying doses to identify the most effective one. Ideal candidates have experienced migraines for over a year, with 2 to 10 moderate to severe attacks each month. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on migraine prevention medication, you should not have changed the dose in the last 3 months or stopped it within 30 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that K-645 has been tested in earlier studies to assess its safety and tolerability. In one study with healthy volunteers, researchers examined how participants handled the drug and how their bodies processed it. This initial research was crucial to ensure the drug does not cause major issues before testing it for migraines.

The current study seeks to identify any side effects in people with migraines. Although all results are not yet available, earlier tests with healthy individuals showed that K-645 was generally well-tolerated, with most participants not experiencing severe side effects. However, as with any new treatment, there is always a possibility of some side effects.

It is important to note that this trial is in an early stage, focusing on finding the right dose and ensuring safety. For those considering participation, this means the treatment has passed initial safety checks but remains under careful study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard migraine treatments, which often include medications like triptans and NSAIDs that focus on relieving symptoms, K-645 is unique because it targets the underlying mechanisms of migraine attacks. Researchers are excited about K-645 because it introduces a new mechanism of action by specifically modulating neural pathways associated with migraines, potentially offering relief with fewer side effects. This targeted approach could make K-645 more effective for individuals who don't respond well to current options, providing a new hope for those seeking better migraine management.

What evidence suggests that K-645 might be an effective treatment for migraine?

Research shows that K-645 is undergoing tests for its effectiveness in treating sudden migraines. Earlier studies found that K-645 might reduce the number of migraine days each month, potentially decreasing their frequency or severity. This trial compares two different treatment sequences of K-645 to determine which is more effective. Early results appear promising, but further research is necessary to confirm its effectiveness. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who frequently experience migraines. Participants should be adults with a history of migraine attacks, but without any serious associated neurological conditions. Specific details about what makes someone eligible or not are not provided here.

Inclusion Criteria

I am between 18 and 65 years old.

I have had migraines for over a year.

I am not able to have children or agree to use birth control.

Exclusion Criteria

My first migraine occurred after I turned 50.

Has difficulty distinguishing his/her migraine attacks from tension-type headaches

My migraines are usually mild and go away on their own in less than 2 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two dose levels of K-645 in a 3-period crossover design to treat acute migraine

6-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• K-645

Trial Overview The study tests two different doses of a medication called K-645 against a placebo to see which is more effective at treating acute migraines. It's conducted across multiple centers where patients will randomly receive either the drug or placebo in different periods, without knowing which they're getting (double-blind).

How Is the Trial Designed?

Group I: Treatment Sequence 2 Experimental Treatment 3 Interventions

Group II: Treatment Sequence 1 Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Kallyope Inc.

Lead Sponsor

Trials

5

Recruited

660+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07116499

A Study of K-645 in the Treatment of Multiple Migraine ... This is a multicenter, randomized, double-blind, placebo-controlled, 3-period crossover study to evaluate the safety, tolerability, and efficacy of two dose ...

2. withpower.com withpower.com/trial/phase-2-acute-migraine-7-2025-70e4a

K-645 for Migraine · Recruiting Participants for Phase ... Trial Overview The study tests two different doses of a medication called K-645 against a placebo to see which is more effective at treating acute migraines.

3. centerwatch.com centerwatch.com/clinical-trials/listings/condition/100/migraine-and-cluster-headaches

Migraine and Cluster Headaches Clinical Research Trials A Study of K-645 in the Treatment of Multiple Migraine Attacks. Phase. 2. Span ... The co-primary efficacy end points are change in migraine days per month and ...

4. policylab.us policylab.us/clinical-trials/l/tennessee/condition/migraine

Migraine Paid Clinical Trials in Tennessee - Policy Lab The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ ...

5. synapse.patsnap.com synapse.patsnap.com/organization/5694d4a99bfcb602f2f6d155e64e5887

Kallyope, Inc. - Drug pipelines, Patents, Clinical trials A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of K-645 in healthy volunteers.

6. synapse.patsnap.com synapse.patsnap.com/drug/0c4c39bb77be46b9a65dec66c0e1ad82

K-645 - Drug Targets, Indications, Patents A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Study of K-645 in the Treatment of Multiple Migraine ...

7. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624001241527

ANZCTR - Registration A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of K-645 in healthy volunteers.