High and Low Dose Carbidopa Treatment of Parkinson's Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: carbidopa |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of Four Week Outpatient Treatment of Parkinson's Disease Comparing High and Low Dose Carbidopa. |
- AUC of tapping speed [ Time Frame: Performed every 30 minutes from 8 AM to 2 PM ] [ Designated as safety issue: No ]Tapping speed is an index of bradykinesia and is used as a response to levodopa infusion.
- AUC of levodopa plaasma concentrations [ Time Frame: Measured every 30 minutes from 9 AM, the beginning of the infusion until 2 PM ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | March 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: High carbidopa followed by low carbidopa
450 mg of carbidopa per day for four weeks followed by 75 mg of carbidopa per day for four weeks
|
Drug: carbidopa
75 mg of carbidopa per day versus 450 mg of carbidopa per day
|
|
Experimental: Low carbidopa followed by high carbidopa
75 mg of carbidopa per day for four weeks followed by 450 mg of carbidopa per day
|
Drug: carbidopa
75 mg of carbidopa per day versus 450 mg of carbidopa per day
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 35 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Idiopathic Parkinson's disease
- Treatment with carbidopa/levodopa
- Motor fluctuations
Exclusion Criteria:
- Dementia
- Hallucinations
- Age greater than 85
Contacts and Locations| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | John G Nutt, MD | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | John Nutt, MD, Oregon Health & Science University |
| ClinicalTrials.gov Identifier: | NCT01399905 History of Changes |
| Other Study ID Numbers: | Aldred4133 |
| Study First Received: | July 21, 2011 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Oregon Health and Science University:
|
Parkinson's disease Levodopa Carbidopa Blood brain barrier |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Carbidopa Antiparkinson Agents |
Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013