Back to resultsEfficacy and Safety of CNV2197944 Versus Placebo in Patients With Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Completed
Phase
Phase 2
Locations
Hungary
Study Type
Interventional
Intervention
CNV2197944
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy
Eligibility Criteria
Inclusion Criteria:
- Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent
- Diabetes Mellitus (Type I or II)with HbA1c <9%
- Evidence of symmetrical bilateral pain in lower limbs with evidence of decreased sensation or impaired reflexes and a Michigan Neuropathy Screening -Instrument score of >3 on physical examination
- Patients with diabetic peripheral neuropathy (DPN) with pain at screening present for more than 6 months. The maximum duration of DPN will be no longer than 5 years
Exclusion Criteria:
- Patients having other severe pain, which may impair the self-assessment of the pain due to DPN
- Patients who have received nerve blocks for neuropathic pain within 4 weeks -Patients on other concomitant medications used to relieve the pain of DPN
- Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin
Sites / Locations
- Petz Aladar County Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CNV2197944
Placebo
Arm Description
CNV2197944 75mg tid 21 days
Placebo 1 cap tid 21 days
Outcomes
Primary Outcome Measures
Pain Intensity Numerical Rating Scale
Secondary Outcome Measures
Pain Responder rates
Neuropathic Pain Symptom Inventory
Full Information
NCT ID
NCT01893125
First Posted
July 2, 2013
Last Updated
October 29, 2014
Sponsor
Convergence Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01893125
Brief Title
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Diabetic Peripheral Neuropathy
Official Title
A Randomised Three Week Double-blind Crossover Study to Compare the Efficacy and Safety of CNV2197944 75 mg Tid Versus Placebo in the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Convergence Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain experienced in diabetic peripheral neuropathy (DPN) as measured by changes in PI-NRS after three weeks of treatment compared to the baseline period.
Detailed Description
A 3 week randomised crossover study to investigate the effect of repeat oral dosing of CNV2197944 75 mg tid versus placebo for on the pain experienced in diabetic peripheral neuropathy (DPN). Each 3 week treatment period is seperated by a 2 week washout period. The primary outcome measure is the change from baseline in the PI-NRS after three weeks of treatment. Secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the Neuropathic Pain Symptom Inventory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNV2197944
Arm Type
Experimental
Arm Description
CNV2197944 75mg tid 21 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 cap tid 21 days
Intervention Type
Drug
Intervention Name(s)
CNV2197944
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pain Intensity Numerical Rating Scale
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Pain Responder rates
Time Frame
21 days
Title
Neuropathic Pain Symptom Inventory
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent
Diabetes Mellitus (Type I or II)with HbA1c <9%
Evidence of symmetrical bilateral pain in lower limbs with evidence of decreased sensation or impaired reflexes and a Michigan Neuropathy Screening -Instrument score of >3 on physical examination
Patients with diabetic peripheral neuropathy (DPN) with pain at screening present for more than 6 months. The maximum duration of DPN will be no longer than 5 years
Exclusion Criteria:
Patients having other severe pain, which may impair the self-assessment of the pain due to DPN
Patients who have received nerve blocks for neuropathic pain within 4 weeks -Patients on other concomitant medications used to relieve the pain of DPN
Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibor Hidvegi, MD, PhD
Organizational Affiliation
Dept. Metabolism and Diabetes, Gyor, Hungary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Petz Aladar County Teaching Hospital
City
Gyor
ZIP/Postal Code
H-9002
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Diabetic Peripheral Neuropathy
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