Hypersensitivity to Phosphodiesterase 5 Inhibition in Post-Traumatic Headache

Summary

To investigate whether sildenafil (phosphodiesterase 5 inhibitor) induces migraine-like headache in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).

Timeline

Start

2023-01-02

Primary completion

2023-12-31

Completion

2023-12-31

Outcome

Met primary endpoint

paper Migraine-like headache occurred in 15 participants (71%) after sildenafil administration, compared with 4 (19%) following placebo (P = 0.003). PMID 41789856 ↗

Publications

• Al-Khazali HM, Christensen RH, Melchior AG, Ashina M, Ashina H. Hypersensitivity to phosphodiesterase-5 inhibition in post-traumatic headache: Evidence of cGMP-dependent signaling. Cephalalgia. 2026 Mar;46(3):3331024261419409. doi: 10.1177/03331024261419409. Epub 2026 Mar 6.

Drugs

Indications