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NCT03307304 · ClinicalTrials.gov registry record

Investigations of Juvenile Neuronal Ceroid Lipofuscinosis

A clinical trial of Batten Disease and Juvenile Neuronal Ceroid Lipofuscinosis (CLN3), sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Recruiting
Registry status
300
Enrollment target
1
Study location

NCT03307304: Recruiting study of Batten Disease and Juvenile Neuronal Ceroid Lipofuscinosis (CLN3), sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

NCT03307304 is a study of Batten Disease and Juvenile Neuronal Ceroid Lipofuscinosis (CLN3) that is actively recruiting participants, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 300 participants, below the 2,802-participant average among 11 other Batten Disease trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03307304, a study of Batten Disease and Juvenile Neuronal Ceroid Lipofuscinosis (CLN3), is actively recruiting participants, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

RECRUITING
Registry status
300 participants
Enrollment target
1
Study location

Study Summary

Background: CLN3, or Batten disease, is a genetic disorder. This deadly disease leads to decline of brain and nervous system functions. Symptoms of CLN3 typically occur between 4 and 7 years of age. They include changes in how a person sees, thinks, and moves. CLN3 can also cause seizures. No effective treatments for the disease are yet known. There is limited testing of potential therapies. Researchers want to study CLN3 more so they can improve future therapies. Objective: To identify clinical or biochemical markers that can be used as therapeutic outcome measures for CLN3. Eligibility: People with CLN3. It must be based on Two CLN3 mutations OR One CLN3 mutation AND findings seen with a powerful microscope Family members of a person with CLN3. Design: Participants will have already been referred to NIH for CLN3 evaluation. If participants agree to do the study, they will: 1. give spinal fluid, blood, urine, and skin samples. They may provide other samples if they were already collected. These may include cells, surgical specimens, and DNA. 2. will be seen by multiple healthcare specialists. Participants may provide medical records or photos. Participants will sign a release of medical records form.P Researchers may send samples or clinical data to other investigators. For research testing, the samples will not include the participant s name. For a test in a clinical lab, researchers will include the participant s name. These results will become part of the clinical record at NIH.

Primary Outcome

Identification of biomarkers

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2017-11-27
Est. Completion 2050-12-31

What NCT03307304 shows while recruiting

NCT03307304 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 2,802-participant average among 11 other Batten Disease trials with a reported enrollment target (89% lower).

The record links to 2 conditions, with Batten Disease appearing as the primary indexed condition, and to 0 interventions.

NCT03307304 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT03307304 about?

NCT03307304 is a clinical study titled "Investigations of Juvenile Neuronal Ceroid Lipofuscinosis". Background: CLN3, or Batten disease, is a genetic disorder. This deadly disease leads to decline of brain and nervous system functions. Symptoms of CLN3 typically occur between 4 and 7 years of age. They include changes in how a person sees, thinks, and moves. CLN3 can also cause seizures. No effec...

What is the current status of trial NCT03307304?

This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2017-11-27. Estimated completion is 2050-12-31.

What conditions does trial NCT03307304 study?

This clinical trial studies the following conditions: Batten Disease, Juvenile Neuronal Ceroid Lipofuscinosis (CLN3).

Who is sponsoring clinical trial NCT03307304?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03307304 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Batten Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03307304's enrollment target sits among peer trials

300 4th of 11 higher than 8 of 11 other Batten Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Batten Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03307304, the US trial registry maintained by the National Library of Medicine. NCT03307304 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.