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

NCT06133491 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Ki Health Partners. LLC
Status	ACTIVE_NOT_RECRUITING
Enrolment	20
Start date	2023-10-18
Completion	2024-12

Conditions

• Chronic Migraine, Headache

Interventions

• Daxibotulinumtonix A

Primary outcomes

• Change from baseline in monthly migraine days over weeks 9-12 as determined by patients reported outcomes on the daily headache diary. — Over weeks 9-12 (4 week period)

Countries

United States