NCT03297294

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

A Double-blind, Placebo-controlled, Randomized Trial to Determine the Safety and Efficacy of EMA401 in Reducing 24-hour Average Pain Intensity Score in Patients With Painful Diabetic Neuropathy (EMPADINE)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This was an interventional, randomized, parallel, placebo-controlled, double-blind treatment study consisting of 3 periods i.e. Screening, Treatment, and Treatment withdrawal. Patients were planned to be randomized in a 1:1 ratio to Placebo b.i.d. or EMA401 100 mg b.i.d.. Concomitant use of pregabalin or duloxetine at stable doses was allowed. Based on historical data, it was planned that the study would enroll approximately 50% of patients who were on stable doses of concomitant pregabalin or duloxetine in the study. At the end of treatment period the 100mg b.i.d. arm was re-randomized (1:1) to the same treatment or placebo. Placebo arm stayed on placebo. The planned duration of treatment period was 12 weeks and 1 week of treatment withdrawal at the end of treatment period. The study was terminated early due to pre-clinical toxicity data that became available after start of trial. Novartis implemented a Urgent Safety Measure (USM) which instructed sites to discontinue study treatment immediately and to have all patients return for additional laboratory assessments (full hematology including coagulation and clinical chemistry panel). Safety data from the USM was presented as a separate outcome measure table and not included in the Adverse Event section

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	EMA401	capsules, oral
DRUG	Placebo	Placebo to EMA401 capsules, oral

Timeline

• Start date: 2018-03-14
• Primary completion: 2019-03-25
• Completion: 2019-03-25
• First posted: 2017-09-29
• Last updated: 2021-10-08
• Results posted: 2020-06-04

Locations

64 sites across 16 countries: Australia, Austria, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, Hungary, Norway, Poland, Portugal, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study