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Safety and Efficacy of Botulinum Toxin A in Patients With Posttraumatic Headache

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 21, 2025 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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).
Trial Details
NCT Number NCT06839118
Lead Sponsor Danish Headache Center
Conditions
(from sponsor)		 Posttraumatic Headache
Related terms Post-Traumatic Headache
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov