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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Spinifex Pharmaceuticals Pty Ltd

Current Primary Outcome: To determine the efficacy of two dose levels of EMA401 compared to placebo in patients with postherpetic neuralgia (PHN), as assessed by the change in the weekly mean of the 24 hour average pain score using an 11-point Numerical Rating Scale (NRS) [ Time Frame: Baseline to approximately Week 14 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To evaluate the effect of EMA401 compared to placebo on the Brief Pain Inventory-Short Form (BPI-SF) interference total score [ Time Frame: Baseline to approximately Week 14 ]
  • To evaluate the effect of EMA401 compared to placebo on the weekly mean of the 24 hour worst NRS pain score [ Time Frame: Baseline to approximately Week 14 ]
  • To evaluate the effect of EMA401 compared to placebo on the Patient Global Impression of Change (PGIC) [ Time Frame: Baseline to approximately Week 14 ]
  • To evaluate the effect of EMA401 compared to placebo on the BPI-SF average pain [ Time Frame: Baseline to approximately Week 14 ]
  • To determine the proportion of EMA401 patients achieving a ≥ 30% and a ≥ 50% reduction in weekly mean pain of the 24 hour average score (NRS) compared to placebo (i.e., responder rates) [ Time Frame: Baseline to approximately Week 14 ]
  • To evaluate the effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI) [ Time Frame: Baseline to approximately Week 14 ]
  • To evaluate the safety and tolerability of EMA401 in patients with PHN as measured by adverse events, vital signs, and laboratory results [ Time Frame: Baseline to approximately Week 14 ]


Original Secondary Outcome: Same as current

Information By: Spinifex Pharmaceuticals Pty Ltd

Dates:
Date Received: April 17, 2015
Date Started: June 2015
Date Completion: December 2016
Last Updated: August 25, 2015
Last Verified: August 2015