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

Summary

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).

Timeline

Start

2025-01-10

Primary completion

2026-03-01

Completion

2026-08-01

Drugs

Indications

No indication recorded.