A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine

Conditions

• Acute Migraine

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Elismetrep (K-304) Dose Level 1 — DRUG
  Administered orally
• Elismetrep (K-304) Dose level 2 — DRUG
  Administered orally
• Elismetrep (K-304) Dose level 3 — DRUG
  Administered orally
• Elismetrep (K-304) Dose level 4 — DRUG
  Administered orally
• Placebo — DRUG
  Administered orally

Study Details

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep as compared to placebo in the treatment of moderate or severe migraine.

Key Dates

First listed

Feb 26, 2025

Start date

Mar 5, 2025

Status verified

Aug 2025

Primary completion

Aug 11, 2025

Completion

Aug 11, 2025

Study Design

Enrollment

431 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elismetrep (K-304) Dose level 1
• Experimental: Elismetrep (K-304) Dose level 2
• Experimental: Elismetrep (K-304) Dose level 3
• Experimental: Elismetrep (K-304) Dose level 4
• Placebo Comparator: Placebo

Primary Outcome Measure

Pain freedom [ Time Frame: 2 hours post-dose ]

Locations (66)

Find similar trials in Birmingham, AL

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