Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the Brain
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ClinicalTrials.gov Identifier: NCT02046434 |
Recruitment Status :
Completed
First Posted : January 27, 2014
Last Update Posted : April 25, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Drug: Glycerol Phenylbutyrate | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phenylbutyrate Response As a Biomarker for Alpha-Synuclein Clearance From Brain |
Actual Study Start Date : | January 2014 |
Actual Primary Completion Date : | September 2019 |
Actual Study Completion Date : | September 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Parkinson's Diesase
Participant will take Glycerol Phenylbutyrate, participant has Parkinson's Disease
|
Drug: Glycerol Phenylbutyrate
Other Name: Ravicti |
Experimental: Control
Participant does not have Parkinson's Disease, Participant will be taking glycerol phenylbutyrate
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Drug: Glycerol Phenylbutyrate
Other Name: Ravicti |
- Levels of alpha-synuclein in blood plasma [ Time Frame: 1 month ]

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Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Idiopathic Parkinson's disease with mild symptoms;
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May be on treatment with dopamine agonists provided that the treating neurologist agrees:
- that the drugs can be stopped for at least three weeks prior to participating in the phenylbutyrate study, and
- 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:
- L-3,4-dihydroxyphenylalanine (L-DOPA);
- monoamine oxidase (MAO) inhibitors,
- catechol-O-methyl transferase (COMT) inhibitors;
- histone deacetylase (HDAC) inhibitors;
- prednisone or other corticosteroids, or
- probenecid.
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Severe cardiopulmonary disease such as:
- congestive heart failure, or
- emphysema requiring supplemental oxygen;
- Renal disease with serum creatinine greater than 2.5;
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History of:
- depression in the prior year;
- epilepsy;
- stroke;
- prior brain surgery;
- dementia, or
- psychosis.

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): NCT02046434
United States, Colorado | |
University of Colorado Denver Anschutz Medical Center | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Curt R Freed, MD | University of Colorado, Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02046434 |
Other Study ID Numbers: |
13-2808 |
First Posted: | January 27, 2014 Key Record Dates |
Last Update Posted: | April 25, 2022 |
Last Verified: | April 2022 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies |
Neurodegenerative Diseases 4-phenylbutyric acid Glycerol Cryoprotective Agents Protective Agents Physiological Effects of Drugs Antineoplastic Agents |