Back to resultsClinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathies
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
EMA401 600mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies
Eligibility Criteria
Inclusion Criteria:
- Patients with Type I or Type II diabetes mellitus with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least six months duration.
- 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 PDN 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 PDN.
- 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).
- Have hemoglobin A1c > 11 %.
- Known history of, or positive laboratory results 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.
- Have undergone neurolytic or neurosurgical therapy or use a neurostimulating device for PDN.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EMA401 600mg
Placebo
Arm Description
2 X 150mg BID
Placebo to match, 2 capsules BID
Outcomes
Primary Outcome Measures
The efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN), as assessed by the difference in the weekly mean of the 24 hour average pain score, using an 11-point Numeric Rating Scale (NRS).
Secondary Outcome Measures
The effect of EMA401 compared to placebo on the BPI-SF interference total score.
The effect of EMA401 compared to placebo on the weekly mean of the 24 hour worst NRS pain score.
The effect of EMA401 compared to placebo, on the Patient Global Impression of Change (PGIC).
The effect of EMA401 compared to placebo on the Brief Pain Inventory-Short Form (BPI-SF) average pain score.
The proportion of EMA401 patients achieving a ≥ 30% and a ≥ 50% reduction in weekly mean 24 hour average pain score compared to placebo (i.e., responder rates).
The effect of EMA401 compared to placebo on the Neuropathic Pain Symptom Inventory (NPSI).
The effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI).
The safety and tolerability of EMA401 in patients with PDN as measured by number and severity of adverse events.
Full Information
NCT ID
NCT02435199
First Posted
April 24, 2015
Last Updated
August 25, 2015
Sponsor
Spinifex Pharmaceuticals Pty Ltd
Collaborators
Syneos Health
1. Study Identification
Unique Protocol Identification Number
NCT02435199
Brief Title
Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
Official Title
A Double-blind, Placebo-controlled, Randomized Trial to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
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 consists of two periods, the Screening Period (~3 weeks) and Treatment Period (12 weeks).
Eligibility for the study will be determined by Screening tests, physical examination/medical history, and fulfilment of eligibility criteria including assessment of pain completed during the Screening Period. Potential participants will be required to provide written informed consent prior to any study-specific Screening procedures being performed.
Following Screening assessments, patients will be randomized to receive either EMA401 300 mg BID or placebo.
Patient study visits during the Treatment Period are at the end of baseline/randomization visit, and end of Weeks 3, 6, 9, and 12, for assessments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
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 600mg
Arm Type
Experimental
Arm Description
2 X 150mg BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match, 2 capsules BID
Intervention Type
Drug
Intervention Name(s)
EMA401 600mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN), as assessed by the difference in the weekly mean of the 24 hour average pain score, using an 11-point Numeric Rating Scale (NRS).
Time Frame
Change from Baseline to Week 12
Secondary Outcome Measure Information:
Title
The effect of EMA401 compared to placebo on the BPI-SF interference total score.
Time Frame
Change from Baseline to Week 12
Title
The effect of EMA401 compared to placebo on the weekly mean of the 24 hour worst NRS pain score.
Time Frame
Change from Baseline to Week 12
Title
The effect of EMA401 compared to placebo, on the Patient Global Impression of Change (PGIC).
Time Frame
Change from Baseline to Week 12
Title
The effect of EMA401 compared to placebo on the Brief Pain Inventory-Short Form (BPI-SF) average pain score.
Time Frame
Change from Baseline to Week 12
Title
The proportion of EMA401 patients achieving a ≥ 30% and a ≥ 50% reduction in weekly mean 24 hour average pain score compared to placebo (i.e., responder rates).
Time Frame
Change from Baseline to Week 12
Title
The effect of EMA401 compared to placebo on the Neuropathic Pain Symptom Inventory (NPSI).
Time Frame
Change from Baseline to Week 12
Title
The effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI).
Time Frame
Change from Baseline to Week 12
Title
The safety and tolerability of EMA401 in patients with PDN as measured by number and severity of adverse events.
Time Frame
Change from Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with Type I or Type II diabetes mellitus with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least six months duration.
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 PDN 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 PDN.
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).
Have hemoglobin A1c > 11 %.
Known history of, or positive laboratory results 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.
Have undergone neurolytic or neurosurgical therapy or use a neurostimulating device for PDN.
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
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