Back to resultsDose Ranging Trial to Determine the Safety and Efficacy of EMA401 in Patients With PHN
Primary Purpose
Neuralgia, Postherpetic
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
EMA401 200 mg
EMA401 600 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia, Postherpetic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
EMA401 200 mg
EMA401 600 mg
Placebo
Arm Description
2 X 50 mg capsules BID
2 X 150 mg capsules BID
Placebo to match 2 capsules BID
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
To evaluate the effect of EMA401 compared to placebo on the Brief Pain Inventory-Short Form (BPI-SF) interference total score
To evaluate the effect of EMA401 compared to placebo on the weekly mean of the 24 hour worst NRS pain score
To evaluate the effect of EMA401 compared to placebo on the Patient Global Impression of Change (PGIC)
To evaluate the effect of EMA401 compared to placebo on the BPI-SF average pain
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)
To evaluate the effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI)
To evaluate the safety and tolerability of EMA401 in patients with PHN as measured by adverse events, vital signs, and laboratory results
Full Information
NCT ID
NCT02426411
First Posted
April 17, 2015
Last Updated
August 25, 2015
Sponsor
Spinifex Pharmaceuticals Pty Ltd
Collaborators
Syneos Health
1. Study Identification
Unique Protocol Identification Number
NCT02426411
Brief Title
Dose Ranging Trial to Determine the Safety and Efficacy of EMA401 in Patients With PHN
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spinifex Pharmaceuticals Pty Ltd
Collaborators
Syneos Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Postherpetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMA401 200 mg
Arm Type
Experimental
Arm Description
2 X 50 mg capsules BID
Arm Title
EMA401 600 mg
Arm Type
Experimental
Arm Description
2 X 150 mg capsules BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match 2 capsules BID
Intervention Type
Drug
Intervention Name(s)
EMA401 200 mg
Intervention Type
Drug
Intervention Name(s)
EMA401 600 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
To evaluate the effect of EMA401 compared to placebo on the Patient Global Impression of Change (PGIC)
Time Frame
Baseline to approximately Week 14
Title
To evaluate the effect of EMA401 compared to placebo on the BPI-SF average pain
Time Frame
Baseline to approximately Week 14
Title
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
Title
To evaluate the effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI)
Time Frame
Baseline to approximately Week 14
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Dose Ranging Trial to Determine the Safety and Efficacy of EMA401 in Patients With PHN
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