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Identification of Biomarkers in Spinocerebellar Ataxia 3 (SCA3)

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ClinicalTrials.gov Identifier: NCT03885167
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Vikram Shakkottai, University of Michigan

Brief Summary:
The purpose of this study is to examine the differences in cerebral spinal fluid (CSF) and blood of patients with spinocerebellar ataxias and healthy volunteers. The goal of this project is to identify new biomarkers that are useful for characterizing spinocerebellar ataxias and identify targets for treatment or prevention of this condition.

Condition or disease Intervention/treatment
Spinocerebellar Ataxia Type 3 Other: Specimen Collection

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Identification of Biomarkers in Spinocerebellar Ataxia 3
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Group/Cohort Intervention/treatment
Affected Individuals with Known SCA3
In order to be eligible for this cohort, participants must have confirmed genetic testing results for Spinocerebellar Ataxia Type 3.
Other: Specimen Collection
No interventions take place as part of study participation- only specimen collection occurs for both cohorts.

Healthy Individual Control Subjects Other: Specimen Collection
No interventions take place as part of study participation- only specimen collection occurs for both cohorts.




Primary Outcome Measures :
  1. Change in Ataxin 3 Levels in Cerebrospinal Fluid Specimens [ Time Frame: 4 Hours ]
  2. Change in Ataxin 3 Levels in Blood Plasma Specimens [ Time Frame: 4 Hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Within the local community and/or those associated with the National Ataxia Foundation.
Criteria

Inclusion Criteria:

  • Confirmed Genetic Testing of SCA3 or Healthy Volunteers

Exclusion Criteria:

  • People with unstable thyroid, intestinal/stomach, heart, liver, kidney, blood, lung, hormones, or other medical or mental disorders at screening Have a tumor or evidence of having a tumor Women who are pregnant or breast feeding Have a chronic infection or any severe acute infection within 3 months prior to screening Take anti-coagulants and NSAIDs Have started any investigational medications in the last month, we must receive confirmation from the study doctor who prescribed the medicine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885167


Contacts
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Contact: Tasha Kaiser, BS 734-232-6247 kaisert@med.umich.edu
Contact: Hayley McLoughlin, PhD 734-763-3511 hayleymc@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Tasha Kaiser    734-232-6247    kaisert@med.umich.edu   
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Vikram Shakkottai, MD University of Michigan

Additional Information:

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Responsible Party: Vikram Shakkottai, Associate Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier: NCT03885167     History of Changes
Other Study ID Numbers: HUM00121991
U01NS106670 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this time, no specific description of a sharing plan was incorporated into the approved grant, and there are no requirements that pertain to this action. Therefore, until more information is obtained as the study progresses, there is no plan to share at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ataxia
Cerebellar Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Machado-Joseph Disease
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn