Actively Recruiting
Safety and Efficacy of Botulinum Toxin A in Patients With Posttraumatic Headache
Led by Danish Headache Center · Updated on 2025-02-21
80
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is an investigator-initiated randomized, placebo-controlled, double-blind, parallelgroup trial. Eighty subjects with PTH will be included and randomized 1:1 for treatment with BTX-A or placebo (isotonic saline). The study comprises a 4-week baseline phase before injection of either active drug or placebo followed by a 12-week evaluation period. Treatment will be double-blind, and subjects will only receive one treatment cycle. Endpoints will be assessed in the evaluation period (weeks 5 to 8) compared to baseline (weeks -4 to -1).
CONDITIONS
Official Title
Safety and Efficacy of Botulinum Toxin A in Patients With Posttraumatic Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of persistent post-traumatic headache according to International Classification of Headache Disorders criteria
- Age between 18 and 80 years
- Headache on at least 15 days per month during the last 4 weeks before baseline
- During baseline phase, at least 8 days with moderate-to-severe headache and at least 15 headache days to qualify for treatment phase
- Fluency in Danish
You will not qualify if you...
- More than two traumatic brain injuries
- Severe cardiovascular or cerebrovascular disease such as ischemic heart disease, myocardial infarction, stroke, or transient ischemic attack, or major cardiovascular interventions in last 3 months
- Expected poor compliance with study visits or procedures
- Ongoing unstable severe psychiatric disease
- Any clinical symptoms deemed relevant to exclude by examining physician
- History of migraine or tension-type headache more than 5 days per month before traumatic brain injury
- Medication-overuse headache
- History of moderate-to-severe traumatic brain injury, whiplash injury, or craniotomy
- Change in preventive post-traumatic headache treatment or dose within 2 months before baseline
- Previous treatment with botulinum toxin type A injections in head or face
- Female pregnancy, breastfeeding, or planned conception during study
- Female of childbearing potential unwilling to use effective contraception during study
- Known allergy to any botulinum toxin type A component
- Infection at proposed injection site
- Known severe neuromuscular disorders or disorders affecting neuromuscular transmission
- Known compromised respiratory function
- Member of investigational site staff or relative of investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Danish Headache Center
Glostrup Municipality, Denmark, 2600
Actively Recruiting
Research Team
L
Lucia Zavala, MD
CONTACT
H
Henrik Schytz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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