Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults

Sponsor
Sichuan Purity Pharmaceutical Technology Co., Ltd.
Study ID
NCT07304518
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PRT-064040 nasal spray — DRUG
    A single dose of PRT-064040 nasal spray
  • Placebo — DRUG
    A single dose of placebo matched to PRT-064040 nasal spray

Study Details

The purpose of this study is to learn about the efficacy and safety of PRT-064040 Nasal Spray versus placebo in the acute treatment of moderate or severe migraine.

Key Dates

First listed
Dec 26, 2025
Start date
Jan 26, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
456 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PRT-064040 nasal spray (dose 1)
    Participants administered a single intranasal dose of PRT-064040 nasal spray (dose 1) on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.
  • Experimental: PRT-064040 nasal spray (dose 2)
    Participants administered a single intranasal dose of PRT-064040 nasal spray (dose 2) on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.
  • Experimental: PRT-064040 nasal spray (dose 3)
    Participants administered a single intranasal dose of PRT-064040 nasal spray (dose 3) on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.
  • Experimental: Placebo
    Participants administered a single intranasal dose of placebo on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.

Primary Outcome Measure

Percentage of Participants With Freedom From Pain at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ]

Central Contacts

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