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NCT02741440 · ClinicalTrials.gov registry record

Natural History of Spinocerebellar Ataxia Type 7 (SCA7)

A clinical trial of Spinocerebellar Ataxia, sponsored by National Eye Institute (NEI).

Recruiting
Registry status
25
Enrollment target
1
Study location

NCT02741440: Recruiting study of Spinocerebellar Ataxia, sponsored by National Eye Institute (NEI).

NCT02741440 is a study of Spinocerebellar Ataxia that is actively recruiting participants, run by National Eye Institute (NEI). The registered enrollment target is 25 participants, below the 208-participant average among 3 other Spinocerebellar Ataxia trials with a reported enrollment target (88% 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

NCT02741440, a study of Spinocerebellar Ataxia, is actively recruiting participants, sponsored by National Eye Institute (NEI).

RECRUITING
Registry status
25 participants
Enrollment target
1
Study location

Study Summary

Background: Spinocerebellar ataxia type 7 (SCA7) is a disease in which people have problems with coordination, balance, speech and vision. It is caused by a change in the ATXN7 gene. A mutation in this ATXN7 gene causes changes in eye cells, which can lead to vision loss. There is no cure for SCA7 but researchers are looking for possible treatments. Researchers need more information about SCA7. They want to collect vision and neurology related data from people with SCA7. They want to learn how and what changes in the eye and brain when the ATXN7 gene isn t working properly. Objective: To learn more about SCA7 and its progression. Eligibility: People ages 12 and older with SCA7. Design: Participants will be screened with medical history and genetic testing from a previous National Eye Institute study or their personal physician. Participants will have at least 7 visits over 5 years. They will have 2 visits during the first week of the study. Then they will be asked to come back every year for the next 5 years. Each visit will last several days and will include: * Medical and eye history * Several eye tests: some will include dilating the pupil with eye drops and taking photos or scans of the eyes. * Electroretinography (ERG): Participants will sit in the dark with their eyes patched for 30 minutes. After this, the patches will be removed and contact lenses put into the eyes. They will watch flashing lights and information will be recorded. * Neurological exams: Sensation, strength, coordination, reflexes, attention, memory, language, and other cognitive functions will be tested. * Brain MRI: They will lie in a machine that takes pictures of the brain. * Blood and urine tests * Optional skin biopsy: About 3 millimeters of skin will be removed for more research testing; this is half the size of a pencil eraser.

Primary Outcome

Determine the amplitude and time of photopic and scotopic responses on electroretinogram

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2016-07-11
Est. Completion 2028-12-31
National Eye Institute (NEI)

221 total trials

What NCT02741440 shows while recruiting

NCT02741440 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 208-participant average among 3 other Spinocerebellar Ataxia trials with a reported enrollment target (88% lower).

The record links to 1 condition, with Spinocerebellar Ataxia appearing as the primary indexed condition, and to 0 interventions.

NCT02741440 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT02741440 about?

NCT02741440 is a clinical study titled "Natural History of Spinocerebellar Ataxia Type 7 (SCA7)". Background: Spinocerebellar ataxia type 7 (SCA7) is a disease in which people have problems with coordination, balance, speech and vision. It is caused by a change in the ATXN7 gene. A mutation in this ATXN7 gene causes changes in eye cells, which can lead to vision loss. There is no cure for SCA7 ...

What is the current status of trial NCT02741440?

This trial is currently recruiting. The enrollment target is 25 participants. The study started on 2016-07-11. Estimated completion is 2028-12-31.

What conditions does trial NCT02741440 study?

This clinical trial studies the following conditions: Spinocerebellar Ataxia.

Who is sponsoring clinical trial NCT02741440?

This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02741440 being conducted?

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

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Source: ClinicalTrials.gov NCT02741440, the US trial registry maintained by the National Library of Medicine. NCT02741440 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.