Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)

Phase 2 Terminated 130 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study was designed to characterize dose response, and evaluate safety and efficacy of three different doses of EMA401 compared to placebo in patients with post-herpetic neuralgia (PHN).

Timeline

Start: 2017-06-27
Primary completion: 2019-03-07
Completion: 2019-03-07

Outcome

Missed primary endpoint

Stopped: “The study was terminated early due to pre-clinical toxicity data that became available after start of trial”

paper numerically in favour of EMA401 100 mg arm in both EMPHENE (treatment difference: -0.5 [95% confidence interval: -1.6 to 0.6; P value: 0.35]) PMID 33675631 ↗

Publications

Rice ASC, Dworkin RH, Finnerup NB, Attal N, Anand P, Freeman R, Piaia A, Callegari F, Doerr C, Mondal S, Narayanan N, Ecochard L, Flossbach Y, Pandhi S. Efficacy and safety of EMA401 in peripheral neuropathic pain: results of 2 randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy. Pain. 2021 Oct 1;162(10):2578-2589. doi: 10.1097/j.pain.0000000000002252.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OLODANRIGAN	Small molecule	25 mg	Oral
Subject	OLODANRIGAN	Small molecule	100 mg	Oral