NCT04349176|TerminatedPhase 3FDA Drug
Study Stopped
Insufficient Recruitment
Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?
OnabotulinumtoxinA for Chronic Headaches: Is 155 Units Superior to 100 Units?
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Insufficient Recruitment
OnabotulinumtoxinA for Chronic Headaches: Is 155 Units Superior to 100 Units?
Sponsor study identifier
interventional
35
1 country
1
Study Start
May 12, 2017
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2017
Actual (reported)December 31, 2019
Actual (reported)April 14, 2020
Actual (reported)April 16, 2020
Actual (reported)December 31, 2022
Actual (reported)mean change in frequency of headache days for the baseline period compared to the 28-day period ending with week 24
24 weeks
frequency of migraine days
24 weeks
proportion of patients with severe (>=60) HIT-6 score
24 weeks
acute headache pain medication intakes
24 weeks
mean change in total HIT-6
24 weeks
Randomized to either 100U or 155U
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Naval Medical Center San Diego
San Diego, California, 92134, United States
35 participants (actual enrollment reported by the registry).
First Submitted
April 14, 2020
First Posted
April 16, 2020
Study Start
May 12, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
February 5, 2024
Record last verified: 2024-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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