NCT04349176

Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?

OnabotulinumtoxinA for Chronic Headaches: Is 155 Units Superior to 100 Units?

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: United States Naval Medical Center, San Diego · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study will enroll patients through the Neurology Department at Naval Medical Center San Diego (NMCSD). Eligible participants will meet criteria for chronic migraine, but will not be excluded based on the presence of significant comorbidities. Participants with comorbidities and medication regimens commonly exhibited within real-world DOD medical settings will not be excluded, such as pain disorders, psychiatric illness, medication overuse, and those who have used prophylactic medication during the baseline period. This will comprise "Group A". A carefully screened group will comprise "Group B" and meet exclusion criteria designed to approximate that of the PREEMPT2 trial. Within each group, half of the patients (155U Arm) will be randomly selected to receive the standard 155U over 31 fixed sites every 12 weeks while the other half (100U Arm) will receive 100U over 19 fixed sites every 12 weeks. Minimum sample size for the entire cohort is 132 participants (maximum n = 180), with a minimum of 66 participants per comparison.

Conditions

• Chronic Migraine, Headache

Interventions

Type	Name	Description
DRUG	Dose	Randomized to either 100U or 155U

Timeline

• Start date: 2017-05-12
• Primary completion: 2019-12-31
• Completion: 2022-12-31
• First posted: 2020-04-16
• Last updated: 2024-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study