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Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435199
Recruitment Status : Withdrawn
First Posted : May 6, 2015
Last Update Posted : August 26, 2015
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Spinifex Pharmaceuticals Pty Ltd

Tracking Information
First Submitted Date  ICMJE April 24, 2015
First Posted Date  ICMJE May 6, 2015
Last Update Posted Date August 26, 2015
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
  • The effect of EMA401 compared to placebo on the BPI-SF interference total score. [ Time Frame: Change from Baseline to Week 12 ]
  • 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 ]
  • The effect of EMA401 compared to placebo, on the Patient Global Impression of Change (PGIC). [ Time Frame: Change from Baseline to Week 12 ]
  • 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 ]
  • 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 ]
  • The effect of EMA401 compared to placebo on the Neuropathic Pain Symptom Inventory (NPSI). [ Time Frame: Change from Baseline to Week 12 ]
  • The effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI). [ Time Frame: Change from Baseline to Week 12 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
Official Title  ICMJE A Double-blind, Placebo-controlled, Randomized Trial to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathies
Intervention  ICMJE
  • Drug: EMA401 600mg
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: EMA401 600mg
    2 X 150mg BID
    Intervention: Drug: EMA401 600mg
  • Placebo Comparator: Placebo
    Placebo to match, 2 capsules BID
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 25, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2015)
210
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02435199
Other Study ID Numbers  ICMJE EMA401-011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spinifex Pharmaceuticals Pty Ltd
Study Sponsor  ICMJE Spinifex Pharmaceuticals Pty Ltd
Collaborators  ICMJE Syneos Health
Investigators  ICMJE Not Provided
PRS Account Spinifex Pharmaceuticals Pty Ltd
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP