NPC-06 to Acute Pain in Herpes Zoster

Phase 2 Terminated 16 enrolled Nobelpharma

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this trial is to investigate the efficiency of pain relief and the safety of NPC-06 for the acute pain in herpes zoster in the placebo-controlled double-blind parallel group trial, in addition to explore the effective concentration of NPC-06.

Timeline

Start: 2019-11-21
Primary completion: 2021-02-28
Completion: 2021-02-28

Outcome

Met primary endpoint

Stopped (Enrollment): “Low recruitment”

paper The slope was significantly lower in the high- and low-dose fosphenytoin groups than in the placebo group (P < 0.001 and P = 0.016, respectively). PMID 38149403 ↗

Publications

Iseki M, Yamamoto T, Ogawa Y, Majima Y, Abe Y, Watanabe D, Amaya F, Hasegawa T, Inafuku K, Kosugi T, Nomura Y, Deguchi T, Hamada T, Shimizu K, Arai S, Takahashi M, Hamada I, Ishikawa Y, Kawashima M. Efficacy and safety of intravenous fosphenytoin for patients with acute herpes zoster-associated pain: A placebo-controlled randomized trial. J Dermatol. 2024 Feb;51(2):234-242. doi: 10.1111/1346-8138.17054. Epub 2023 Dec 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fosphenytoin	Small molecule	12 mg/kg	Intravenous
Subject	Fosphenytoin	Small molecule	18 mg/kg	Intravenous