Pregabalin Treatment for RDEB Pain and Itch

Summary

Recessive dystrophic epidermolysis bullosa (RDEB) patients' quality of life is severely affected by neuropathic pain and itch, which have recently been demonstrated to be secondary to skin small fiber neuropathy. To date, there is no evidence on what the best agent is to control these symptoms. Based on the anecdotal data and safety profile, the investigators believe that pregabalin is a therapeutic agent that will be effective and safe in this population. The investigators propose to conduct a blinded study, using pregabalin versus placebo in which each patient serves as its own control (cross-over design). This is a feasibility study that will provide preliminary data on efficacy and safety of pregabalin in RDEB patients with neuropathic pain and itch and gather much needed data (dosage, titration schedule, outcome measures, etc) to inform the design of a larger cohort, controlled, multicenter trial.

Timeline

Start

2019-08-07

Primary completion

2023-03-01

Completion

2024-02-01

Outcome

Met primary endpoint

paper The results of this randomized crossover trial indicate that pregabalin significantly reduced pain and itch scores from baseline compared to placebo in patients with RDEB. PMID 39441591 ↗

Publications

• Calvo M, Tejos-Bravo M, Passi-Solar A, Espinoza F, Fuentes I, Lara-Corrales I, Pope E. Pregabalin for Neuropathic Pain and Itch in Recessive Dystrophic Epidermolysis Bullosa: A Randomized Crossover Trial. JAMA Dermatol. 2024 Dec 1;160(12):1314-1319. doi: 10.1001/jamadermatol.2024.3767.

Drugs

Indications