Status:
COMPLETED
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Diabetic Peripheral Neuropathy
Lead Sponsor:
Convergence Pharmaceuticals
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01893125
Start Date
August 1 2013
End Date
September 1 2014
Last Update
October 30 2014
Active Locations (1)
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1
Petz Aladar County Teaching Hospital
Győr, Gyor, Hungary, H-9002