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

This study has been completed.
Information provided by (Responsible Party):
Convergence Pharmaceuticals Identifier:
First received: July 2, 2013
Last updated: October 29, 2014
Last verified: October 2014
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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Pain Responder rates [ Time Frame: 21 days ]
  • Neuropathic Pain Symptom Inventory [ Time Frame: 21 days ]

Enrollment: 126
Study Start Date: August 2013
Study Completion Date: September 2014
Primary Completion Date: June 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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01893125

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

Responsible Party: Convergence Pharmaceuticals Identifier: NCT01893125     History of Changes
Other Study ID Numbers: CNV2197944/202
Study First Received: July 2, 2013
Last Updated: October 29, 2014

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases processed this record on August 17, 2017