NCT02426411

Dose Ranging Trial to Determine the Safety and Efficacy of EMA401 in Patients With PHN

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Spinifex Pharmaceuticals Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neuralgia, Postherpetic

Interventions

Type	Name	Description
DRUG	EMA401 200 mg
DRUG	EMA401 600 mg
DRUG	Placebo

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2015-04-24
• Last updated: 2015-08-26