This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers. The trial lasts 16 weeks, with a 4-week baseline phase and a 12-week randomization phase. Four visits are planned: 1) Introduction and baseline data collection, 2) Medical evaluation and treatment assignment, 3) Follow-up with biomarker analysis, and 4) Trial conclusion interview. 80 participants will be included and randomized 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Subcutaneously injections are given unilaterally in the face at predefined injection sites.
Subcutaneously injections are given unilaterally in the face at predefined injection sites.
Danish Headache Center
Glostrup Municipality, Denmark
RECRUITINGProportion of responders in botulunim toxin A and placebo group
Responders are participants with a 30 % reduction in mean average daily pain score.
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Biomarkers
The degree of concentration change in inflammatory biomarkers (CGRP, CRP, TNF alpha, IL1, IL2, and IL6) in responders versus non-responders in BTX-A and placebo group.
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Tear fluid CGRP
The difference in tear fluid calcitonin gene-related peptide (CGRP) between the symptomatic side and the asymptomatic side.
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
50 % reduction
The proportion of subjects reaching ≥50% reduction in mean Average Daily Pain (ADP) intensity score
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
75 % reduction
The proportion of subjects reaching ≥75% reduction in mean ADP
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Prolonged 30 % reduction
The proportion of subjects reaching ≥30% reduction in mean ADP
Time frame: Week 9 to 12 compared with baseline (week -4 to -1)
Change in paroxysms
Change in mean number of daily pain paroxysms n BTX-A group and placebo group
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Time frame: Evaluation period (week 2 to 5) and during weeks 9 to 12 compared with baseline (week -4 to -1)
PGI-C
Proportion of subjects with a Patient Global Impression of Change (PGI-C) scale response of "much improved" or "very much improved" in BTX-A and placebo group
Time frame: Week 5
PENN Facial Pain Scale-Revised (PENN-FPS-R)
Change in the PENN-FPS-R
Time frame: Baseline to week 5
Patient's guess
Proportion of subjects correctly guessing whether they received BTX-A or placebo
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Dropouts
Proportion of dropouts caused by increased intake of trigeminal neuralgia (TN) medication or use of rescue medication in BTX-A group compared to the placebo group through study completion.
Time frame: Up to 24 weeks
Side effects
Proportion of subjects with side-effects registered in weeks 2 to 5 during treatment with BTX-A compared with placebo through study completion.
Time frame: Up to 24 weeks