High and Low Dose Treatment of Carbidopa in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title: A Randomized Controlled Trial of Four Week Outpatient Treatment of Parkinson's Disease Comparing High and Low Dose Carbidopa.

Status Completed

Clinical Trial Summary

1. Briefly describe the purpose of this protocol:

• 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.

2. Briefly describe the procedures subjects will undergo:

• 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. The investigators will leave subjects a message if the investigators cannot reach them. If there are any problems, the investigators 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. The investigators will leave them a message if we cannot reach them. If there are any problems, the investigators 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.

3. If applicable, briefly describe survey/interview instruments used.

• 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.

4. Briefly describe how the data will be analyzed to address the purpose of the protocol.

• 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT00745277
• Study type: Interventional
• Source: Oregon Health and Science University
• Status: Completed
• Phase: Phase 2
• Start date: August 2008
• Completion date: May 2011