155
Participants
Start Date
February 13, 2019
Primary Completion Date
December 7, 2021
Study Completion Date
January 24, 2022
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."
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."
Presidio Ospedale San Paolo, Milan
University Hospitals Leuven, Leuven
Aristotle University of Thessaloniki AHEPA Hospital Thessaloniki, Thessaloniki
CTIG - Teknon, Barcelona
Fondazione PTV Policlinico Tor Vergata, Roma
Lead Sponsor
Omikron Italia S.r.l.
INDUSTRY