Phase 3: testing Elismetrep for Migraine

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Elismetrep, or Placebo. The registry lists allocation as randomized. This is a neither you nor the study doctors know who gets the real treatment, randomly assigned, multicenter, outpatient evaluation of the how well it works, safety, and tolerability of elismetrep, as compared with dummy treatment (placebo), in the acute treatment of migraine.

They plan to enroll about 1,800 people at 112 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Elismetrep, Placebo

Primary outcome (registry wording): Pain freedom at 2 hours post-dose

Who it is for (from inclusion criteria)

• Ages 18 Years to 75 Years
• a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by 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 level \> 40 mIU/mL or
• Acceptable methods of birth control are:
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
• Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable)
• Intrauterine device (IUD);