Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?

Chronic Migraine, Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04349176
• Other study ID #: NMCSD.2016.0039
• Status: Terminated
• Phase: Phase 3
• Start date: May 12, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine, Headache
• Headache
• Migraine Disorders

Intervention

Drug:
• Dose
Randomized to either 100U or 155U

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean change in frequency of headache days for the baseline period compared to the 28-day period ending with week 24		24 weeks
Secondary	frequency of migraine days		24 weeks
Secondary	proportion of patients with severe (>=60) HIT-6 score		24 weeks
Secondary	acute headache pain medication intakes		24 weeks
Secondary	mean change in total HIT-6		24 weeks