NCT02435199

Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy

A Double-blind, Placebo-controlled, Randomized Trial to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Spinifex Pharmaceuticals Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study consists of two periods, the Screening Period (\~3 weeks) and Treatment Period (12 weeks). Eligibility for the study will be determined by Screening tests, physical examination/medical history, and fulfilment of eligibility criteria including assessment of pain completed during the Screening Period. Potential participants will be required to provide written informed consent prior to any study-specific Screening procedures being performed. Following Screening assessments, patients will be randomized to receive either EMA401 300 mg BID or placebo. Patient study visits during the Treatment Period are at the end of baseline/randomization visit, and end of Weeks 3, 6, 9, and 12, for assessments.

Conditions

• Diabetic Neuropathies

Interventions

Type	Name	Description
DRUG	EMA401 600mg
DRUG	Placebo

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2015-05-06
• Last updated: 2015-08-26