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CompletedNCT01893125Updated Oct 30, 2014

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

A Phase 2 interventional study of CNV2197944 and Placebo in Diabetic Peripheral Neuropathy, sponsored by Convergence Pharmaceuticals. Completed at 1 site in Hungary. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-10-30.

Sponsored by Convergence Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Peripheral Neuropathy
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 126 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Convergence Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    CNV2197944

    CNV2197944 75mg tid 21 days

    Drug: CNV2197944

  • Placebo comparator
    Placebo

    Placebo 1 cap tid 21 days

    Drug: Placebo

Interventions

  • DrugCNV2197944
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Pain Intensity Numerical Rating Scale

    Time frame: 21 days

Secondary outcomes

  1. Pain Responder rates

    Time frame: 21 days

  2. Neuropathic Pain Symptom Inventory

    Time frame: 21 days

07

Study locations

1 site
  • Petz Aladar County Teaching Hospital
    Gyor, H-9002, Hungary
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01893125
Lead sponsor
Convergence Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 8, 2013
Start date
Aug 2013
Primary completion
Jun 2014
Completion
Sep 2014
Last update
Oct 30, 2014

Study contacts

Tibor Hidvegi, MD, PhD
principal investigator · Dept. Metabolism and Diabetes, Gyor, Hungary

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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