Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Double-blind, Placebo-controlled, Randomized Trial to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
Brief 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.