- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04349176
Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?
OnabotulinumtoxinA for Chronic Headaches: Is 155 Units Superior to 100 Units?
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Sarah Hodges, DO
- Phone Number: 6195327472
Study Locations
-
-
California
-
San Diego, California, United States, 92134
- Naval Medical Center San Diego
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 :
- criteria C and D for 1.1 Migraine without aura
- criteria B and C for 1.2 Migraine with aura
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A 100U
|
Randomized to either 100U or 155U
|
Experimental: Group A 155U
|
Randomized to either 100U or 155U
|
Experimental: Group B 100U
|
Randomized to either 100U or 155U
|
Experimental: Group B 155
|
Randomized to either 100U or 155U
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean change in frequency of headache days for the baseline period compared to the 28-day period ending with week 24
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
frequency of migraine days
Time Frame: 24 weeks
|
24 weeks
|
proportion of patients with severe (>=60) HIT-6 score
Time Frame: 24 weeks
|
24 weeks
|
acute headache pain medication intakes
Time Frame: 24 weeks
|
24 weeks
|
mean change in total HIT-6
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCSD.2016.0039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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