NCT06154070

An Open Label, Study of DaxibotulinumtoxinA for Migraine Prevention

A Multi-Center Unblinded Proof-of-Concept Study of DaxibotulinumtoxinA for Migraine: the 'EEG Paradigm'

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Ki Health Partners. LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, 24-week trial of DAX for the preventive treatment of frequent migraine attacks ( ≥8 MMDs per month, currently termed high-frequency episodic migraine (HFEM), or if there are 15 or more of any headache type, CM). The purpose of this study is to assess the safety and effectiveness of the study drug, DaxibotulinumtoxinA (DAXXIFY) over a 24-week period. DaxibotulinumtoxinA (Manufactured by Revance Therapeutics, Inc.). The primary objective of this proof-of-concept study is to evaluate DAX effectiveness administered subcutaneously according to a novel, proprietary injection pattern ("EEG paradigm") for the preventive treatment of High Frequency Migraine/Chronic Migraine (HFEM/CM) assessed by reduction of monthly migraine days. Evaluation of the duration of efficacy as determined by prespecified rules for retreatment (50% or increase in MMDs from nadir (look-back to weeks 4-12) beginning at week 16, along with a 1-point or more worsening in the PGIC. * Evaluation of the safety of DAX in migraine patients * Evaluation of time to "wear-off" (need for retreatment) * Reduction of acute migraine medication use compared to baseline * Patient-reported outcomes (PROs): * MIDAS * PGIC (Patient Global Impression of Change)

Conditions

• Migraine Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-24
• Primary completion: 2024-09-01
• Completion: 2024-10-01
• First posted: 2023-12-01
• Last updated: 2024-05-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study