Diabetic Neuropathies Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomized Trial to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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