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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04349176
Other study ID # NMCSD.2016.0039
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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