A Phase II Study of NB001 for Acute Migraine Treatment

Sponsor
Chinese PLA General Hospital
Study ID
NCT07577050
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • One tablet of NB001 plus three tablets of placebo — DRUG
    Take 1 tablet of NB001 + 3 tablets of placebo at the onset of moderate-to-severe acute migraine.
  • Two tablets of NB001 plus two tablets of placebo — DRUG
    Take 2 tablets of NB001 plus 2 tablets of placebo at the onset of moderate-to-severe acute migraine.
  • Four tablets of NB001 — DRUG
    Take 4 tablets of NB001 at the onset of moderate-to-severe acute migraine.
  • Four tablets of placebo — DRUG
    Take 4 tablets of placebo at the onset of moderate-to-severe acute migraine.

Study Details

The goal of this observational study is to Evaluate the Efficacy and Safety of NB001 for the Acute Treatment of Migraine in Adult patients diagnosed with migraine.

Key Dates

First listed
May 11, 2026
Start date
Apr 20, 2026
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: One tablet of NB001 plus three tablets of placebo
  • Experimental: Two tablets of NB001 plus two tablets of placebo
  • Experimental: Four tablets of NB001
  • Placebo Comparator: Four tablets of placebo

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: 2 hours post-dose ]

Central Contacts

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