Observational Study Aimed at Evaluating the Trend of Neuropathic Pain Through the Reduction of the NRS Questionnaire Score in Patients Treated With PEACETIL

Istituto Auxologico Italiano3 sites in 1 country122 target enrollmentJune 9, 2023

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neuropathic Pain
Sponsor: Istituto Auxologico Italiano
Enrollment: 122
Locations: 3
Primary Endpoint: Change in neuropathic pain after two months of treatment with Peacetil
Status: Completed
Last Updated: last year

The present study aims to evaluate the trend of neuropathic pain in patients treated with Peacetil for a period of two months.

Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score.

Registry

clinicaltrials.gov

Start Date

June 9, 2023

End Date

June 20, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•Patients with new or recent diagnosis of acute or chronic neuropathic pain in which the clinician decides to introduce treatment with PEACETIL according to common clinical practice, belonging to one of the following categories:
•Dysmetabolic polyneuropathy (e.g. diabetic neuropathy),
•Chemotherapy treatment neuropathy,
•Compressive mononeuropathy,
•Radiculopathy,
•Postherpetic and non-postherpetic trigeminal neuralgia;
•The patient must be able to understand the informed consent of the study;
•Must adhere to the procedures established by the study;
•DN4 score \>4 at T0 (month 0);

•Neurological disorders confounding the primary objective;
•Clinical condition which during the observational study requires the introduction or modification of the dosage of drugs which are also indicated for the treatment of acute or chronic pain
•Introduction or modification of the dosage of drugs used to treat acute and chronic neuropathic pain (including other nutraceuticals) from 30 days before the start of the study until the end of the study.
•Presence of unstable psychiatric illness, cognitive impairment, dementia, or substance abuse that would compromise the participant's ability to provide informed consent, as judged by the investigator;
•Clinically significant unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, serious laboratory test abnormality, or clinically significant ECG changes) that would pose a risk to the participant if they were to participate in the study, in the judgment of the 'investigator.