NCT01893125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 30, 2014

Status Verified

October 1, 2014

Enrollment Period

10 months

First QC Date

July 2, 2013

Last Update Submit

October 29, 2014

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Numerical Rating Scale

    21 days

Secondary Outcomes (2)

  • Pain Responder rates

    21 days

  • Neuropathic Pain Symptom Inventory

    21 days

Study Arms (2)

CNV2197944

EXPERIMENTAL

CNV2197944 75mg tid 21 days

Drug: CNV2197944

Placebo

PLACEBO COMPARATOR

Placebo 1 cap tid 21 days

Drug: Placebo

Interventions

CNV2197944DRUG
CNV2197944
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Petz Aladar County Teaching Hospital

Győr, Gyor, H-9002, Hungary

Location

Study Officials

  • Tibor Hidvegi, MD, PhD

    Dept. Metabolism and Diabetes, Gyor, Hungary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 8, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

October 30, 2014

Record last verified: 2014-10

Locations

HU(1)