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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Convergence Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Convergence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01893125
First received: July 2, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Diabetic Peripheral Neuropathy
Drug: CNV2197944
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Convergence Pharmaceuticals:

Primary Outcome Measures:
  • Pain Intensity Numerical Rating Scale [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Responder rates [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: August 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNV2197944
CNV2197944 75mg tid 21 days
Drug: CNV2197944
Placebo Comparator: Placebo
Placebo 1 cap tid 21 days
Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893125

Contacts
Contact: Kevin P Gunn, MD +44 1223 755501 kevin.gunn@convergencepharma.com

Locations
Hungary
Petz Aladar County Teaching Hospital Recruiting
Gyor, Hungary, H-9002
Sponsors and Collaborators
Convergence Pharmaceuticals
Investigators
Principal Investigator: Tibor Hidvegi, MD, PhD Dept. Metabolism and Diabetes, Gyor, Hungary
  More Information

No publications provided

Responsible Party: Convergence Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01893125     History of Changes
Other Study ID Numbers: CNV2197944/202
Study First Received: July 2, 2013
Last Updated: January 7, 2014
Health Authority: Hungary: National Institute of Pharmacy
Hungary: Ministry of Health, Social and Family Affairs
Czech Republic: State Institute for Drug Control
Romania: National Medicines Agency
Bulgaria: Bulgarian Drug Agency
Poland: Ministry of Health

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014