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High and Low Dose Carbidopa Treatment of Parkinson's Disease

NCT01399905 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-01-09

Study results available
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Summary

Hypothesis: We hypothesize that carbidopa in daily doses of 450mg will enter the central nervous system and partially inhibit AAAD, thereby reducing the decarboxylation of exogenous levodopa to dopamine, and thereby blunt the therapeutic effects of levodopa in PD subjects.

The purpose of this study is to see how low dose vs. high dose of the study drug, carbidopa effect movement in subjects with Parkinson's disease. The low dose of the study drug is 75 mg and the high dose is 450mg.

Subjects will be recruited from the investigators clinic when they are seen for treatment for Parkinson's disease. Subjects will also be recruited through flyers hung at OHSU and at the VA.

Subjects will take part in 2 screening visits one week apart to determine eligibility. Subjects will be randomly chosen to start either high or low dose carbidopa and take it for 4 weeks. Subjects will be called 2, 4, and 6 or 7 days after this visit to ask how they are doing after starting this dose of study drug. We will leave them a message if we cannot reach them. If there are any problems, we will schedule them to come to the clinic within the next 2 days.

Subjects will have an outpatient visit 2 weeks after screening and a hospital admission 2 weeks after that. At the hospital, subjects will stay for 3 days. They will have blood drawn and their Parkinson's disease assessed by a finger tapping exercise, timing their walking, and looking at their uncontrolled movements.

The subject will then receive the opposite dose of carbidopa for 4 weeks. Subjects will be called 2, 4, and 6 or 7 days after this visit to ask how they are doing after starting this dose of study drug. We will leave them a message if we cannot reach them. If there are any problems, we will schedule them to come to the clinic within the next 2 days.

The outpatient visit and hospital admission will repeat again. At the end of the second hospital admission, treatment on the study is over and subjects will go back to their original Parkinson's disease medications. The study will end with a follow up phone call or clinic visit 2 - 4 weeks after the final hospital admission.

Subjects will fill out a daily diary that asks about their movement throughout the day for 3 days before they come to the Oregon Clinical and Translational Research Institute.

Carbidopa is used for the treatment of Parkinson's disease with levodopa. This protocol is using a high dose of 450mg of carbidopa. This study is also using IV levodopa, which is a different route than is normally given.

Finger tapping rates will be compared between high and low dose study drug use to see if one group has slower rates than the other.

Conditions

Interventions

DRUG

carbidopa

75 mg of carbidopa per day versus 450 mg of carbidopa per day

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • John G Nutt, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-04-30
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01399905 on ClinicalTrials.gov