Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?

Phase 3

Terminated

• Conditions: Chronic Migraine, Headache
• Interventions: Drug: Dose

• Registration Number: NCT04349176
• Lead Sponsor: United States Naval Medical Center, San Diego

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-12
• Primary Completion: 2019-12-31
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Study Completion: 2022-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Chronic migraine headache - Diagnostic criteria:

A. Headache (tension-type-like and/or migraine-like) on 15 days per month for >3 months2 and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura

C. On 8 days per month for >3 months, fulfilling any of the following 3 :

1. criteria C and D for 1.1 Migraine without aura
2. criteria B and C for 1.2 Migraine with aura
3. believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D. Not better accounted for by another ICHD-3 diagnosis. -

Exclusion Criteria

Previous exposure at any time to any botulinum toxin serotype Pregnancy, breastfeeding or plans to become pregnant within 6 months Age <18 years Failure to complete at least 20 days of headache diary in the 28 day baseline period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A 155U	Dose	-
Group A 100U	Dose	-
Group B 100U	Dose	-
Group B 155	Dose	-

Primary Outcome Measures

Name	Time	Method
mean change in frequency of headache days for the baseline period compared to the 28-day period ending with week 24	24 weeks

Secondary Outcome Measures

Name	Time	Method
mean change in total HIT-6	24 weeks
acute headache pain medication intakes	24 weeks
frequency of migraine days	24 weeks
proportion of patients with severe (>=60) HIT-6 score	24 weeks

Trial Locations

Locations (1)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States