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Neuronal Ceroid-Lipofuscinoses clinical trials

View clinical trials related to Neuronal Ceroid-Lipofuscinoses.

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NCT ID: NCT05791864 Active, not recruiting - Clinical trials for Neuronal Ceroid Lipofuscinosis Type 2

A First-in-Human Study in Pediatric Patients With Ocular CLN2 Disease

Start date: May 17, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human, open-label, single ascending dose study of RGX-381 for the treatment of ocular manifestations of CLN2 (Batten disease).

NCT ID: NCT05174039 Active, not recruiting - Batten Disease Clinical Trials

An Open-label Safety, Pharmacokinetic, and Efficacy Study of Miglustat for the Treatment of CLN3 Disease

Start date: February 2, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label study in approximately 6 subjects in 2 centers to assess the safety, PK, and efficacy of the maximum tolerable dose (MTD) of oral miglustat (100 mg once daily [QD] to 200 mg 3 times daily [TID]) in subjects ≥ 17 years of age with CLN3 disease over a period of 104 weeks.

NCT ID: NCT05152914 Active, not recruiting - Clinical trials for Neuronal Ceroid Lipofuscinosis Type 2

Intravitreal ERT to Prevent Retinal Disease Progression in Children With CLN2

Start date: November 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II randomized, masked, clinical trial to determine the safety and efficacy of intravitreal administration of cerliponase alfa.

NCT ID: NCT04476862 Active, not recruiting - Clinical trials for Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2

Cerliponase Alfa Observational Study in the US

Start date: August 19, 2020
Phase:
Study type: Observational

This is a multicenter, observational study for patients with a confirmed diagnosis of neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as TPP1 deficiency, who intend to be or are currently being treated with cerliponase alfa. Patients receiving or expected to receive cerliponase alfa within 60 days of signing the informed consent form (ICF) may be eligible to enroll in the study, assuming all regulatory requirements for sites that have agreed to participate and protocol inclusion criteria are met. Data may be collected for all or some of the assessments as outlined in the protocol, dependent upon the clinic's and/or individual patient's standard of care.

NCT ID: NCT04273243 Active, not recruiting - Batten Disease Clinical Trials

Long-Term Follow Up of CLN6 Batten Disease Subjects Following Gene Transfer

Start date: January 24, 2020
Phase:
Study type: Observational

This is a long-term safety and efficacy study in subjects with CLN6 Batten disease who previously received a single intrathecal administration of AT-GTX-501.

NCT ID: NCT04098211 Active, not recruiting - Clinical trials for Neuronal Ceroid-Lipofuscinoses

Longitudinal Assessment of Atypical Tripeptidyl Peptidase 1 Enzyme Deficiency Patients

Start date: November 1, 2019
Phase:
Study type: Observational

The purpose of this study is to gather information on the possible symptoms that patients with atypical neuronal ceroid lipofuscinosis type 2 (also known as aTPP1 or atypical tripeptidyl peptidase deficiency) have and how they change over time.

NCT ID: NCT03770572 Active, not recruiting - Batten Disease Clinical Trials

Gene Therapy for Children With CLN3 Batten Disease

Start date: November 13, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2, open-label, single dose, dose-escalation clinical trial to evaluate the safety and efficacy of AT-GTX-502 (previous NCH Code: scAAV9.P546.CLN3) delivered intrathecally into the lumbar spinal cord region of subjects with CLN3 Batten disease.