Safety and Efficacy of Botulinum Toxin A in Patients With Posttraumatic Headache
ConditionPosttraumatic Headache
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDanish Headache Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A diagnosis of persistent PTH according to criteria 5.2.2 Persistent headache attributed to mild traumatic injury to the head according to The International Classification of Headache Disorders 3rd edition.
Age between 18 and 80 years.
Subjects must have headache at least 15 days per month during the last 4 weeks to enter the baseline phase.
During baseline phase subjects must experience moderate-to-severe headache at least 8 days and headache at least 15 days to enter the treatment phase (to be randomized).
Disqualifiers
More than 2 TBI's.
Severe cardiovascular and cerebrovascular disease such as ischemic heart disease, myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions during the last three months.
Expected poor compliance, i.e., considered unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge.
Ongoing and unstable severe psychiatric disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Botox 200 UNT Injection
DrugA concentration of 50U/mL BTX-A is prepared using saline in four syringes: one with 1 mL, one with 0.8 mL, one with 0.7 mL, one with 0.6 mL. This equals a total administration dose of 155U. A total of 155U BTX-A will be injected at day 1 (first day in week 1) by subcutaneous injections according to the PREEMPT protocol.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: BTX-AExperimental treatment 1 intervention
Group B: Isotonic salinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary aim
To investigate if botulinum toxin type A (BTX-A) is safe and more effective than placebo to lower the number of moderate-to-severe headache days in the evaluation period (weeks 5 to 8) compared to baseline (weeks -4 to -1). Headache days will defined as mild, moderate or severe in intensity based on the International Headache Society guideline for conduction studies on preventive medication in post-traumatic headache
Time frame
3 monthsSecondary outcomes
1
First secondary aim
To investigate the degree of change in inflammatory biomarkers concentration in plasma and tears in responders versus non-responders in the BTX-A and placebo groups at week 0 and week 8.
Time frame
2 months2
Second secondary aim
To investigate the proportion of subjects reaching a ≥50% or a ≥75% reduction in the number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1), respectively.
Time frame
3 months3
Third secondary aim
To evaluate the change from baseline period (weeks -4 to -1) to evaluation period (weeks 5 to 8) in Headache Impact Test (HIT-6) at week 8 in the BTX-A group versus the placebo group.
Time frame
3 months4
Fourth secondary aim
To evaluate the change from baseline period (weeks -4 to -1) to evaluation period (weeks 5 to 8) in Headache Impact Test (HIT-6) at week 8 in the BTX-A group versus the placebo group.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov