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

NCT ID: NCT01893125

Last Updated: 2014-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-09-30

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.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CNV2197944

CNV2197944 75mg tid 21 days

Group Type: EXPERIMENTAL

CNV2197944

Intervention Type: DRUG

Placebo

Placebo 1 cap tid 21 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

CNV2197944

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Convergence Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tibor Hidvegi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. Metabolism and Diabetes, Gyor, Hungary

Locations

Petz Aladar County Teaching Hospital

Győr, Gyor, Hungary

Countries

Hungary

Other Identifiers

CNV2197944/202

Identifier Type: -

Identifier Source: org_study_id