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Open Label, 6-month Study for High Frequency and Chronic Migraine,

NCT06133491 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-08-27

No results posted yet for this study

Summary

This is a prospective, multi-center, unblinded study in patients with migraine (≥ 8 MMDs/month) requiring preventive treatment. Enrolled patients will receive DAX administered subcutaneously using an established, published, legacy injection paradigm (referred to herein as the "standard paradigm"). The safety and efficacy outcome measures will be assessed at selected dosing segments during the 24-week treatment phase.

Conditions

  • Chronic Migraine, Headache

Interventions

BIOLOGICAL

Daxibotulinumtonix A

SQ injections of 10u per site will be given over standard landmarks (18 sites) to patients who consent and are found eligible.

Sponsors & Collaborators

  • The Los Angeles Headache Center

    collaborator UNKNOWN

  • Revance Therapeutics, Inc.

    collaborator INDUSTRY

  • Ki Health Partners. LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2024-09-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06133491 on ClinicalTrials.gov