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

Diabetic Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893125
• Other study ID #: CNV2197944/202
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2013
• Last updated: October 29, 2014
• Start date: August 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Convergence Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyHungary: Ministry of Health, Social and Family AffairsCzech Republic: State Institute for Drug ControlRomania: National Medicines AgencyBulgaria: Bulgarian Drug AgencyPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• CNV2197944

• Placebo

Locations

Country	Name	City	State
Hungary	Petz Aladar County Teaching Hospital	Gyor

Sponsors (1)

Lead Sponsor	Collaborator
Convergence Pharmaceuticals

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Numerical Rating Scale		21 days	No
Secondary	Pain Responder rates		21 days	No
Secondary	Neuropathic Pain Symptom Inventory		21 days	No