NCT06133491

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

A Multi-Center Unblinded Proof-of-Concept Study of DaxibotulinumtoxinA for Migraine Prevention in High-Frequency and Chronic Migraine: the Standard Paradigm

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Ki Health Partners. LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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.

Detailed description

Patients enrolled who meet eligibility will receive a total of 310 units of DAXI Injections in divided doses over 31 landmarks (sites), including the face, head, neck and shoulders, as identified per the standard paradigm, at visit 2. Follow-up visits via combination of phone and in office will occur at V3, week 8, through V9, week 24.

Conditions

• Chronic Migraine, Headache

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-18
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2023-11-15
• Last updated: 2024-08-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study