Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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7 June 2021 |
Main ID: |
NCT02046434 |
Date of registration:
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23/01/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the Brain
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Scientific title:
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Phenylbutyrate Response As a Biomarker for Alpha-Synuclein Clearance From Brain |
Date of first enrolment:
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January 2014 |
Target sample size:
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40 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02046434 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Curt R Freed, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Colorado, Denver |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Idiopathic Parkinson's disease with mild symptoms;
- May be on treatment with dopamine agonists provided that the treating neurologist
agrees:
1. that the drugs can be stopped for at least three weeks prior to participating in
the phenylbutyrate study, and
2. for the 4-week duration of the study.
- Age and sex matched normal control subjects from spouses and the general population;
- In good general health;
- Controlled hypertension, or
- Controlled hypercholesterolemia with medication.
Exclusion Criteria:
- Pregnant women;
- Current treatment with:
1. L-3,4-dihydroxyphenylalanine (L-DOPA);
2. monoamine oxidase (MAO) inhibitors,
3. catechol-O-methyl transferase (COMT) inhibitors;
4. histone deacetylase (HDAC) inhibitors;
5. prednisone or other corticosteroids, or
6. probenecid.
- Severe cardiopulmonary disease such as:
1. congestive heart failure, or
2. emphysema requiring supplemental oxygen;
- Renal disease with serum creatinine greater than 2.5;
- History of:
1. depression in the prior year;
2. epilepsy;
3. stroke;
4. prior brain surgery;
5. dementia, or
6. psychosis.
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Glycerol Phenylbutyrate
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Primary Outcome(s)
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Levels of alpha-synuclein in blood plasma
[Time Frame: 1 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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