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Neuronal Ceroid-Lipofuscinoses clinical trials

View clinical trials related to Neuronal Ceroid-Lipofuscinoses.

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NCT ID: NCT04644549 Terminated - Batten Disease Clinical Trials

Natural History Study of Batten Disease

Start date: April 27, 2021
Phase:
Study type: Observational

This is a multicenter, international, study to assess the natural history data from people with Batten disease by collecting both retrospective and prospective information about the motor, behavioral and functional capabilities of patients. The study initially has 2 cohorts. Cohort 1 (n ≈ 75) includes subjects with CLN6 Batten disease. Cohort 2 (n ≈ 120) includes subjects with juvenile CLN3 Batten disease. Additional cohorts for other Batten disease subtypes may be added in the future.

NCT ID: NCT04637282 Not yet recruiting - Clinical trials for Juvenile Neuronal Ceroid Lipofuscinosis

Safety, Tolerability, and Efficacy of PLX-200 in Patients With CLN3

Start date: December 1, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of multiple doses of PLX-200 in patients with CLN3 disease.

NCT ID: NCT04613089 Recruiting - Batten Disease Clinical Trials

Natural History and Longitudinal Clinical Assessments in NCL / Batten Disease, the International DEM-CHILD Database

Start date: April 8, 2020
Phase:
Study type: Observational [Patient Registry]

This is an observational study that aims at assessing the natural history of NCL diseases as part of the international DEM-CHILD Database. 1. Patient data are collected from medical records, patient questionnaires and routine follow up clinical examinations with focus on assessing progression in key areas of disease such as motor, language, cognition, seizures, vision, and behavior. 2. A local biorepository of samples from genetically defined NCL patients will be established as well as a virtual biorepository within the DEM-CHILD DB to be able to easily localize international availability of patient samples.

NCT ID: NCT04480476 Withdrawn - Clinical trials for Late-infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)

A Retrospective, Natural History Study in Children With CLN2

Start date: March 31, 2021
Phase:
Study type: Observational

This is a multi center, retrospective, chart review study to document the evolution of ocular disease progression in pediatric patients with CLN2.

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: NCT04462692 Withdrawn - Clinical trials for Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)

An Observational Study in Children With CLN2 Batten Disease

Start date: March 31, 2021
Phase:
Study type: Observational

This is a prospective, longitudinal natural history study to document the progression of ocular manifestations of CLN2 disease among a community-dwelling population of pediatric participants affected by this disease.

NCT ID: NCT04461561 Recruiting - Cancer Clinical Trials

Using NPT to Evaluate Providing PPC as ELNEC-PPC WBT for Nurses

ELNEC-PPC
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to explain the provision of palliative care at the end of life by the implementation of the ELNEC course, as WBT Program using the Normalization Process Theory, that focus attention on how complex interventions become routinely embedded in practice. In addition to, identify the changes implemented by the participant nurses (intervention group) in their clinical practice, after participating in WBT Program to provide Palliative Care alongside with usual care versus usual care only (control group) for children with life-limiting conditions or in the case of accidents/sudden death, at the end of life. And finally, provide findings that will assist in the interpretation of the trial results.

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: NCT03862274 Enrolling by invitation - Batten Disease Clinical Trials

Examining Developmental Outcomes of Children Diagnosed With CLN2 Disease

Start date: December 1, 2018
Phase:
Study type: Observational

The investigators propose a study to assess cognitive and developmental outcomes of patients with CLN2 that are untreated and receiving cerliponase alfa. This study aims to validate standardized assessment measures to establish a standard of care. The secondary aim is to compare cognitive and developmental outcomes of patients with CLN2 that are receiving celiponase alfa to a natural history cohort. To accomplish specific aims of the study, the investigators will use a multi-method approach to collect retrospective data collected as standard of care and prospective developmental data in children with CLN2 disease. The investigators will use a combination of standardized measures that include direct assessment and parent report of child development. The investigators focus will also include multiple measures of development including language, motor, social-emotional, and adaptive functioning.