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PlainTrials
RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing BR005-036C for Migraine, With or Without Aura

This study wants to compare the how well it works and safety of BR005-036C versus dummy treatment (placebo) in subjects with Acute Migraines

Official registry: https://clinicaltrials.gov/study/NCT07792681 · Brise Pharmaceuticals Co., Ltd. · enrollment listed as 2,079

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

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 BR005-036C, BR005-036C, or Placebo. The registry lists allocation as randomized. This study wants to compare the how well it works and safety of BR005-036C versus dummy treatment (placebo) in subjects with Acute Migraines

They plan to enroll about 2,079 people at 83 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study Evaluating the Efficacy and Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults

Interventions: BR005-036C, BR005-036C, Placebo

Primary outcome (registry wording): Percentage of Participants with Freedom from Pain at 2 hours post-dose

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Male or female Participants aged 18 years or older
  • Patients diagnosed with migraine with or without aura in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3), with a disease history of at least 1 year
  • Onset age of migraine shall be less than 50 years old
  • At least 2-8 moderate-to-severe migraine attacks per month within 3 months prior to screening visit
  • Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit
  • Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry

Public study contact (from the registry)

Brise Pharmaceuticals Co., Ltd.

+81-21-80517689

ra@brisepharma.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

83 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT07792681 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07792681?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07792681?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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