Status:
COMPLETED
Trehalose in Subjects With Neuronal Ceroid Lipofuscinoses
Lead Sponsor:
IRCCS Fondazione Stella Maris
Conditions:
Neuronal Ceroid-Lipofuscinoses
Eligibility:
All Genders
7-45 years
Brief Summary
Neuronal Ceroid Lipofuscinoses (NCL) or Batten's disease are the most common juvenile neurodegenerative disease, characterized by early blindness, movement disorders, cognitive and behavioral impairme...
Detailed Description
This study aims to collect clinical and laboratory data of patients with NCL taking Trehalose.
Eligibility Criteria
Inclusion
- NCL genetic diagnosis (mutation in genes CLN3 or CLN6)
- Signed informed consent
Exclusion
- Other concomitant neurodegenerative diseases.
- Therapeutic and eating changes in the last four months prior to the study
- Unstable clinical conditions (myoclonus worsening, instability in sleep, parenteral nutrition)
- Refusal to sign the informed consent
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04808297
Start Date
August 1 2020
End Date
October 1 2021
Last Update
April 11 2022
Active Locations (1)
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1
IRCCS Fondazione Stella Maris
Pisa, PI, Italy, 56128