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Study of Neurotidine® Intake on Life Quality of Patients With Glaucoma

NCT04046809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2022-04-29

No results posted yet for this study

Summary

The purpose for the study consists in the assessment of the role of Neurotidine® (citicoline oral solution) on the dopaminergic pathway and particularly its potential implications on psychophysical performance and quality of life. Other objectives are the assessment of the tolerability and safety of Neurotidine®.

Conditions

Interventions

OTHER

Food for special medical purposes: Neurotidine®

Each patient will be given the bottles for the first 3-month treatment period by the hospital pharmacist and will be asked to return them at the end of the period (3 months). Then the patients will be given the other bottles for the next phase of the study (3 months): these will contain placebo if the patient received Neurotidine® in the first phase of the study and vice versa. Again, the patients will be asked to return after 3 months with the study bottles and will be given the last set of bottles for the final phase of the study (3 months). Administration at a dosage of 10 ml in the morning.

OTHER

Placebo

Each patient will be given the bottles for the first 3-month treatment period by the hospital pharmacist and will be asked to return them at the end of the period (3 months). Then the patients will be given the other bottles for the next phase of the study (3 months): these will contain placebo if the patient received Neurotidine® in the first phase of the study and vice versa. Again, the patients will be asked to return after 3 months with the study bottles and will be given the last set of bottles for the final phase of the study (3 months). Administration at a dosage of 10 ml in the morning.

Sponsors & Collaborators

  • Omikron Italia S.r.l.

    lead INDUSTRY

Principal Investigators

  • Luca Rossetti, Prof. · Presidio Ospedale San Paolo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-13
Primary Completion
2021-12-07
Completion
2022-01-24

Countries

  • Belgium
  • Greece
  • Italy
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046809 on ClinicalTrials.gov