NCT07116499TerminatedPhase 2
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Study of K-645 in the Treatment of Multiple Migraine Attacks
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Kallyope Inc.
- Enrollment
- 134
- Locations
- 18
- Primary Endpoint
- Percentage of participants with pain freedom
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
This is a double-blind study where the Sponsor, site staff and participants will be blinded to the treatment assignment.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment Sequence 1
Experimental
Intervention: Placebo (Drug)
Treatment Sequence 1
Experimental
Intervention: K-645 dose level 1 (Drug)
Treatment Sequence 1
Experimental
Intervention: K-645 dose level 2 (Drug)
Treatment Sequence 2
Experimental
Intervention: Placebo (Drug)
Treatment Sequence 2
Experimental
Intervention: K-645 dose level 1 (Drug)
Treatment Sequence 2
Experimental
Intervention: K-645 dose level 2 (Drug)
Outcomes
Primary Outcomes
Percentage of participants with pain freedom
Time Frame: 2 hours post-dose
Secondary Outcomes
- Percentage of participants with freedom from the most bothersome symptom(2 hours post-dose)
- Percentage of participants who report pain relief(2 hours post-dose)
- Percentage of participants who experienced 1 or more treatment-emergent adverse events (AEs)(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)(up to 7 days after the last dose of study medication)
Investigators
Study Sites (18)
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