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

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.

Study Overview

• Status: Withdrawn
• Conditions: Neuralgia, Postherpetic
• Intervention / Treatment: Drug: Placebo; Drug: EMA401 200 mg; Drug: EMA401 600 mg

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be diagnosed as suffering from PHN defined as pain in the region of the rash persisting for more than six months after onset of herpes zoster rash.
• Be assessed as suffering from moderate to severe pain across the Screening Period. The assessment of moderate and severe pain will be made using an algorithm proprietary to Spinifex. The Investigator/site staff will be informed immediately as to whether the patient is eligible or ineligible on the ePRO website based on the patient entering all relevant pain scores in the eDiary device.
• Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at the Screening Visit (Visit 1) and within 72 hours prior to administration of IP.

Exclusion Criteria:

• Patients taking any topical treatment for their PHN at the time of Screening Visit 2 will be excluded, including lidocaine plaster, capsaicin patch, and any other topical preparations of these or any other topical medications (e.g., aspirin, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)) for their PHN.
• Have a blood pressure reading, after resting for at least five minutes, outside a systolic blood pressure range of 84-151 mmHg or a diastolic blood pressure > 95 mmHg. If the blood pressure is outside of the range, a repeat measurement can be taken after the patient has rested. The repeat measurement should be used as the screening value.
• Have serum aspartate transaminase (AST) or alanine transaminase (ALT) levels > 1.5 x the upper limit of normal or have total bilirubin concentrations > 1.5 x the upper limit of normal at Screening (Visit 1).
• Patients who have a known diagnosis of diabetes and are stable on medication with a hemoglobin A1c > 8%. Those who do not have a known diagnosis of diabetes with a hemoglobin A1c > 7%.
• Have active herpes zoster upon physical examination at Screening (Visit 1) or during the study.
• Known history of, or positive laboratory result for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection as defined by being seropositive for hepatitis B surface antigen (HBsAg), HCV antibodies or HIV antibodies respectively.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMA401 200 mg; 2 X 50 mg capsules BID	Drug: EMA401 200 mg
Experimental: EMA401 600 mg; 2 X 150 mg capsules BID	Drug: EMA401 600 mg
Placebo Comparator: Placebo; Placebo to match 2 capsules BID	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	Baseline to approximately Week 14

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the effect of EMA401 compared to placebo on the Brief Pain Inventory-Short Form (BPI-SF) interference total score	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	Baseline to approximately Week 14
To evaluate the effect of EMA401 compared to placebo on the Patient Global Impression of Change (PGIC)	Baseline to approximately Week 14
To evaluate the effect of EMA401 compared to placebo on the BPI-SF average pain	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)	Baseline to approximately Week 14
To evaluate the effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI)	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	Baseline to approximately Week 14

Collaborators and Investigators

• Sponsor: Spinifex Pharmaceuticals Pty Ltd
• Collaborators: Syneos Health

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: April 17, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 24, 2015

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 25, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: EMA401-006