Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN)

Phase 2 Terminated 142 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN).

Timeline

Start: 2018-03-14
Primary completion: 2019-03-25
Completion: 2019-03-25

Outcome

Missed primary endpoint

Stopped: “Study was terminated due to animal toxicity data”

registry analysis (superiority test); EMA401 100mg BID DB vs Placebo BID DB; p = 0.101; least squares mean -0.6 (95% CI -1.4 to 0.1); ANCOVA NCT03297294 ↗

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	100 mg	Oral