Recruiting PHASE4 Migraine

Tests treatment safety and results for Migraine

Official title Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications

ClinicalTrials.gov ID: NCT06401642

What this study is testing

What is Zavegepant?

Zavegepant is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for migraine.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Zavegepant (Zavzpret) is approved for the acute treatment of migraine with or without aura in the US. The purpose of this study is to investigate the effectiveness and tolerability of zavegepant for the acute treatment of migraine attacks amongst participants who are using calcitonin gene-related peptide (CGRP) migraine preventive treatments.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Meets International Classification of Headache Disorders 3 (ICHD-3) diagnostic criteria for migraine with or without aura
  • At least 18 years of age
  • 2- 8 migraine attacks per month
  • Participants should be on a calcitonin gene-related peptide (CGRP)-targeting preventive migraine medication on a stable dose for a) ≥2 months prior...
  • Atogepant

You likely can't join if

  • Primary headache disorders other than migraine (tension-type headache days are allowed)
  • History of hypersensitivity reaction to zavegepant or to any of the components of zavegepant Eligibility Notes
  • Participants may have either episodic or chronic migraine.
  • Prior use of zavegepant and other gepants is permitted.
  • Participants can be using migraine preventive medications/treatments in addition to the CGRP-targeting preventive treatment, as long as those...
  • Must have 4 or more migraine days per month, on average, during the 2 months prior to the Screening Visit, according to participant self-report...
See the full eligibility criteria
Who can join
  • Meets International Classification of Headache Disorders 3 (ICHD-3) diagnostic criteria for migraine with or without aura
  • At least 18 years of age
  • 2- 8 migraine attacks per month
  • Participants should be on a calcitonin gene-related peptide (CGRP)-targeting preventive migraine medication on a stable dose for a) ≥2 months prior to zavegepant treatment if an oral gepant or a monoclonal antibody...
  • Atogepant
  • Eptinezumab
  • Erenumab
  • Fremanezumab
  • Galcanezumab
  • Rimegepant
What rules you out
  • Primary headache disorders other than migraine (tension-type headache days are allowed)
  • History of hypersensitivity reaction to zavegepant or to any of the components of zavegepant Eligibility Notes
  • Participants may have either episodic or chronic migraine.
  • Prior use of zavegepant and other gepants is permitted.
  • Participants can be using migraine preventive medications/treatments in addition to the CGRP-targeting preventive treatment, as long as those treatments have been stable for at least two months at the time of...
  • Must have 4 or more migraine days per month, on average, during the 2 months prior to the Screening Visit, according to participant self-report. Exclusion Criteria
  • History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant.

The study team makes the final eligibility decision.

Where it's taking place

  • Phoenix, Arizona, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.