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

NCT02426411 | Withdrawn Phase 2

• 1 other identifier: EMA401-006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuralgia, Postherpetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (3)

EMA401 200 mg

EXPERIMENTAL

2 X 50 mg capsules BID

Drug: EMA401 200 mg

EMA401 600 mg

EXPERIMENTAL

2 X 150 mg capsules BID

Drug: EMA401 600 mg

Placebo

PLACEBO COMPARATOR

Placebo to match 2 capsules BID

Drug: Placebo

Interventions

EMA401 200 mg DRUG

EMA401 200 mg

EMA401 600 mg DRUG

EMA401 600 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spinifex Pharmaceuticals Pty Ltd: lead
• Syneos Health: collaborator

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

EMA400

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 24, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 26, 2015

Record last verified: 2015-08