diabetic neuropathy MedDRA version: 12.0 Level: LLT Classification code 10029331 Term: Neuropathy peripheral
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: palmitoylethanolamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Tabl
Sponsors
ISTITUTO NEUROLOGICO "CARLO BESTA"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? caucasian male or female ? aged 18 to 75 years inclusive ? clinical diagnosis of diabetic neuropathy ? an IENF density at Screening Visit ≤ 5 at distal leg ? written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? patients with neuropathy due to possible other causes ? patients affected by psychiatric disorders ? pregnant or lactating women ? subjects with history of alcohol or drug abuse ? subjects who have received an experimental drug or have participated in a clinical trial within 3 month prior to screening ? employees of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of that investigator or study centre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if palmitoylethanolamide treatment induces the regeneration of skin nerve fibres in patients with diabetic neuropathy.;Secondary Objective: Nessuno;Primary end point(s): intraepidermal nerve fibre (IENF) density at distal leg | — |
Countries
Italy
Outcome results
None listed