Neuralgia, Postherpetic Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomized Dose Ranging Trial to Determine the Safety and Efficacy of Two Dose Levels of EMA401 in Patients With Postherpetic Neuralgia
The study is a randomized, double blind, placebo-controlled, parallel-group comparison (two dose levels of EMA401 versus a placebo group), of safety and efficacy in patients with postherpetic neuralgia.
Screening Period (Up to Four Weeks) to confirm eligibility for the study which will be
determined by Screening tests, physical examination/medical history and fulfillment of
eligibility criteria including assessment of pain.
Study Period (14 Weeks) Approximately 360 eligible male and female patients will receive
double-blind treatment for 14 weeks. Patients will be randomized in a 1:1:1 ratio to
treatment with EMA401 100 mg BID, 300 mg BID or placebo.
Patients will attend the study site at the end of the Baseline visit and end of Weeks 1, 3,
5, 7, 9, 11, 13, and 14 for on-study assessments.
;
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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