Observational Study Aimed at Evaluating the Trend of Neuropathic Pain

Neuropathic Pain Clinical Trial

— NEURATIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324123
• Other study ID #: 23C304
• Status: Recruiting
• Start date: June 9, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Alberto Doretti, MD
• Phone: 02619112937
• Email: neurotrial[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

Inclusion Criteria:

• 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);

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Other:
• Peacetil
Nutraceutical supplement Peacetil for a period of 2 months

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milan	Lombardy
Italy	ASST Fatebenefratelli Sacco	Milano
Italy	Fondazione Don Carlo Gnocchi ONLUS	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neuropathic pain after two months of treatment with Peacetil	Assessed by the Numerical Rating Scale (NRS) score	At enrollment and at two months after the start of treatment with Peacetil
Secondary	Change in neuropathic pain after one month of treatment with Peacetil	Assessed by the Numerical Rating Scale (NRS) score	At enrollment and at one month after the start of treatment with Peacetil