Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Diabetic Peripheral Neuropathy

Phase 2

Completed

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Drug: Placebo; Drug: CNV2197944

• Registration Number: NCT01893125
• Lead Sponsor: Convergence Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-08
• Study Start: 2013-08
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-29
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 1 cap tid 21 days
CNV2197944	CNV2197944	CNV2197944 75mg tid 21 days

Primary Outcome Measures

Name	Time	Method
Pain Intensity Numerical Rating Scale	21 days

Secondary Outcome Measures

Name	Time	Method
Neuropathic Pain Symptom Inventory	21 days
Pain Responder rates	21 days

Trial Locations

Locations (1)

Petz Aladar County Teaching Hospital; 🇭🇺 Gyor, Hungary