Neuropathic PainNEURATILNCT06324123
Observational Study Aimed at Evaluating the Trend of Neuropathic Pain
An observational study of Neuropathic Pain, run by Istituto Auxologico Italiano at 3 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Peacetil
- How many people
- 122 participants
- Where
- 3 sitesItaly
- Study dates
- 9 Jun 2023to 20 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Monitoring of the reduction of neuropathic pain after 1 month and after 2 months of treatment with the nutraceutical PEACETIL, introduced according to clinical practice, and 1 month after the end of treatment. Evaluation of the pain scale upon signing of the consent, after 1 month, after two months of treatment and after 1 month from the suspension of PEACETIL using the following questionnaires: * Numerical Rating Scale (NRS); * Visual Rating Scale (VAS); * DN4 questionnaire.
Who may be able to join
- 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;
Show all 9Show fewer
- 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);
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Istituto Auxologico Italiano
Milan, Lombardy, 20149
ASST Fatebenefratelli Sacco
Milan, 20157
Fondazione Don Carlo Gnocchi ONLUS
Milan
About this study
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
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.
- Conditions
- Neuropathic Pain
- Being tested
- Peacetil
- Keywords
- Neuropathic Pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeacetilOther
Nutraceutical supplement Peacetil for a period of 2 months
| Study group | Role | What they receive |
|---|---|---|
| Patients with neuropathic pain | Patients with acute or chronic neuropathic pain Receives: Other: Peacetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuropathic pain after two months of treatment with Peacetil
Assessed by the Numerical Rating Scale (NRS) score
Measured: At enrollment and at two months after the start of treatment with Peacetil
Secondary outcomes (1)
Change in neuropathic pain after one month of treatment with Peacetil
Assessed by the Numerical Rating Scale (NRS) score
Measured: At enrollment and at one month after the start of treatment with Peacetil
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start9 Jun 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324123
- Sponsor's protocol ID
- 23C304
- Acronym
- NEURATIL
- Status last verified
- Dec 2024
- First submitted
- 6 Mar 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06324123
- Acronym / sponsor ID
- NEURATIL / 23C304
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with neuropathic pain | – | Other: PeacetilPatients with acute or chronic neuropathic pain |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Monitoring of the reduction of neuropathic pain after 1 month and after 2 months of treatment with the nutraceutical PEACETIL, introduced according to clinical practice, and 1 month after the end of treatment. Evaluation of the pain scale upon signing of the consent, after 1 month, after two months of treatment and after 1 month from the suspension of PEACETIL using the following questionnaires: * Numerical Rating Scale (NRS); * Visual Rating Scale (VAS); * DN4 questionnaire.
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeacetilNutraceutical supplement Peacetil for a period of 2 months | Other | Patients with neuropathic pain |
Primary outcome
Change in neuropathic pain after two months of treatment with Peacetil
Time frame: At enrollment and at two months after the start of treatment with Peacetil
Assessed by the Numerical Rating Scale (NRS) score
1 secondary outcome
Change in neuropathic pain after one month of treatment with Peacetil
Time frame: At enrollment and at one month after the start of treatment with Peacetil
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Istituto Auxologico Italiano at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neuropathic pain after two months of treatment with Peacetil (time frame: At enrollment and at two months after the start of treatment with Peacetil). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.