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NCT01934998 · ClinicalTrials.gov registry record
Parkinsonism in Spinocerebellar Ataxia Type 6
A clinical trial, sponsored by University of Chicago.
- Completed
- Registry status
- 20
- Enrollment target
NCT01934998: Completed study, sponsored by University of Chicago.
NCT01934998 is a clinical trial that has completed, run by University of Chicago. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01934998 has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
The spinocerebellar ataxias (SCAs) are a genetically heterogeneous group of dominantly inherited progressive ataxia disorders. More than 30 different gene loci have been identified so far. The most common SCAs, which together account for more than half of all affected families, are SCA1, SCA2, SCA3, and SCA6. Each of these disorders is caused by a translated CAG repeat expansion mutation. SCA1, SCA2, and SCA3 usually have an onset between 30 and 40, and SCA6 usually begins at the age of 50 to 60. In addition to progressive ataxia, SCA1, SCA2, and SCA3 frequently present with additional non-ataxic symptoms, including parkinsonism. Carbidopa/levodopa was found to have a good therapeutic effect on parkinsonism. The SCA6 used to be considered a pure cerebellar disorder. However, a recent large study on natural history of SCAs found that patients with SCA6 often had nonataxia symptoms, an observation that challenges the view that SCA6 is a purely cerebellar disorder. Parkinsonism in SCA6 was rarely reported, except in a case serial, or a small size study in Korean patients. Dopamine transporter (DAT) is a very reliable dopaminergic neuronal marker. Reduction in DAT density detected by I123 SPECT DaTscanTM in the dopaminergic neuron terminal striatum was reported in one small size study consisting of eight SCA6 patients in Korea. There was also a PET study using different radioligand for DAT in a small group of SCA6 patients in Germany, which found sub-clinical change in DAT density in some patients with SCA6. There has been no study so far in the US on parkinsonism and other non-ataxia spectrum and striatal dopaminergic damage in SCA6, probably because non-ataxia feature of SCA6 hasn't received much attention, and also because DaTscanTM hasn't been clinically available in US until recently. The only two published studies on SCA6 and DAT were from Korea and Germany, which were of small subject size. There has been no treatment available for SCA6 so far. Our hypothesis
Primary Outcome
The UPDRS-II and -III scores
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-04 |
What the finished NCT01934998 record still lists
NCT01934998 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01934998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01934998 about?
NCT01934998 is a clinical study titled "Parkinsonism in Spinocerebellar Ataxia Type 6". The spinocerebellar ataxias (SCAs) are a genetically heterogeneous group of dominantly inherited progressive ataxia disorders. More than 30 different gene loci have been identified so far. The most common SCAs, which together account for more than half of all affected families, are SCA1, SCA2, SCA3,...
What is the current status of trial NCT01934998?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2013-07. Estimated completion is 2015-04.
Who is sponsoring clinical trial NCT01934998?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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