Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
Status:
Withdrawn
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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.