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Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the Brain

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease

Intervention: Glycerol Phenylbutyrate (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Curt R Freed, MD, Principal Investigator, Affiliation: University of Colorado, Denver

Summary

This is a Phase I clinical trial of the FDA approved drug Glycerol Phenylbutyrate to see if phenylbutyrate can increase the removal of alpha-synuclein from the brain into the bloodstream. Alpha-synuclein forms abnormal protein deposits in dopamine neurons and is believed to cause the death of brain cells, leading to Parkinson's Disease.

Clinical Details

Official title: Phenylbutyrate Response As a Biomarker for Alpha-Synuclein Clearance From Brain

Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Levels of alpha-synuclein in blood plasma

Detailed description: This is a Phase I clinical trial of phenylbutyrate in 20 Parkinson patients and 20 age- and sex-matched normal control subjects to see if phenylbutyrate can increase the removal of alpha-synuclein from the brain into the bloodstream. All subjects will receive 20 grams/day of phenylbutyrate in the liquid form phenylbutyrate-triglyceride taken as one teaspoonful three times per day with meals. Blood will be drawn on two days prior to starting phenylbutyrate to measure alpha-synuclein concentrations. Phenylbutyrate-triglyceride will then be started and the change in plasma alpha-synuclein will be measured on day 1, 7, 14, and 21 days while taking phenylbutyrate. After 21 days, the drug will be stopped and a final blood sample will be measured at 28 days to see if plasma alpha-synuclein has fallen to its pre-phenylbutyrate level. No effects on Parkinson symptoms are expected during this short trial. Please note that although taking any type of Parkinson's drugs for symptomatic treatment disqualifies you, if you and your neurologist are willing and able to have you off Parkinson medication for six weeks before and during the trial, you may be eligible to participate.

Eligibility

Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with idiopathic Parkinson's disease and mild symptoms and not requiring

symptomatic treatment with L-3,4-dihydroxyphenylalanine (L-DOPA) or other anti-Parkinson drugs. Prior to entering the study, subjects 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 will be recruited from spouses and the

general population.

- All subjects will be in good general health.

- Candidates with hypertension or hypercholesterolemia controlled with medication are

eligible. Exclusion Criteria:

- Because of possible drug interactions and the unknown teratogenic risk of

phenylbutyrate, exclusion criteria for both patients and controls include:

- 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

- Probenecid

- Severe cardiopulmonary disease such as congestive heart failure or emphysema

requiring supplemental oxygen.

- Renal disease with serum creatinine greater than 2. 5, history of depression in the

prior year, epilepsy, stroke, prior brain surgery, dementia, or psychosis will also exclude candidates.

Locations and Contacts

University of Colorado Denver Anschutz Medical Center, Aurora, Colorado 80045, United States
Additional Information

Starting date: January 2014
Last updated: March 2, 2015

Page last updated: August 23, 2015

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