A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

Conditions

• Migraine

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BHV-3500 (zavegepant) — DRUG
  BHV-3500 (zavegepant) softgel capsule.
• Placebo — DRUG
  Matching placebo softgel capsule.

Study Details

The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

Key Dates

First listed

Mar 18, 2021

Start date

Mar 26, 2021

Status verified

Mar 2025

Primary completion

Mar 21, 2024

Completion

Mar 21, 2024

Study Design

Enrollment

1,753 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Active Comparator: BHV-3500 200mg
  Zavegepant 200mg oral soft gel capsule.
• Placebo Comparator: Placebo 200mg
  Matching placebo 200mg oral soft gel capsule.
• Active Comparator: BHV-3500 100mg
  Zavegepant 100mg oral soft gel capsule.
• Placebo Comparator: Placebo 100mg
  Matching placebo 100mg oral soft gel capsule.

Primary Outcome Measure

Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12) [ Time Frame: Observation Phase: 28 days prior to randomization and baseline; Entire DBT Phase: 12 weeks (Week 1 through 12) ]

Locations (116)

Find similar trials in Phoenix, AZ

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