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An Open Label, Study of DaxibotulinumtoxinA for Migraine Prevention

NCT06154070 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2024-05-10

No results posted yet for this study

Summary

This is a prospective, multi-center, unblinded study in patients with migraine (≥ 8 MMDs(monthly migraine days)/month) requiring preventive treatment.

Enrolled patients will receive DAXXIFY (DAX/Doxibutlinumtoxin A)administered subcutaneously per the EEG paradigm (injection pattern).

The safety and efficacy outcome measures will be assessed at selected dosing segments during the 24-week treatment phase as well as the Post Treatment (4 weeks).

There are 2 sites in the U.S. participating, where a total of 20 patients will be enrolled.

Conditions

  • Migraine Disorders

Interventions

DRUG

DaxibotulinumtoxinA

Patients enrolled who meet eligibility will receive a total of 344 units of DAXI Injections in divided doses over 19 landmarks, including the face, head and shoulders, as identified per the EEG paradigm, at visit 2. Follow-up visits via combination of phone and in office will occur at V3, week 8 thru V9, week 24.

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
2023-10-24
Primary Completion
2024-09-30
Completion
2024-10-31
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 NCT06154070 on ClinicalTrials.gov