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

This study has been completed.
Sponsor:
Collaborators:
Parkinson Disease Research, Education and Clinical Center at Portland VA Hospital
RJG Foundation
Oregon Clinical and Translational Research Institute
Information provided by (Responsible Party):
John G. Nutt, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00745277
First received: September 2, 2008
Last updated: November 28, 2012
Last verified: November 2012
  Purpose
  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.

Condition Intervention Phase
Parkinson's Disease
Drug: Carbidopa-Levodopa
Drug: Carbidopa- Levodopa
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.

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Bradykinesia, assessed by alternate finger tapping [ Time Frame: Week 5 and week 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of levodopa [ Time Frame: week 5 and week 9 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2008
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subjects will be randomly chosen to receive high dose carbidopa plus levodopa and take it for 4 weeks. After a hospital inpatient stay, the subject will then receive a low dose carbidopa plus levodopa for 4 weeks followed by one last hospital inpatient stay. The hospital stays include IV administration of the levodopa.
Drug: Carbidopa- Levodopa

For the first four weeks, the patient will receive carbidopa 450mg daily plus levodopa at level the patient was taking prior to start of study.

For the last 4 weeks, the patient will receive carbidopa 75mg daily plus placebo, plus previous dose of levodopa

Other Name: sinemet
Active Comparator: 2
Subjects will be randomly chosen to receive low dose carbidopa plus levodopa and take it for 4 weeks. After a hospital inpatient stay, the subject will then receive high dose carbidopa plus levodopa for 4 weeks followed by one last hospital inpatient stay. The hospital stays will include IV administration of levodopa.
Drug: Carbidopa-Levodopa

For the first four weeks, the patient will receive carbidopa 75mg daily plus placebo, plus levodopa at level the patient was taking prior to start of study.

For the last 4 weeks, the patient will receive carbidopa 450mg daily plus previous dose of levodopa

Other Name: Sinemet

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's disease patient as judged by history and physical examination.
  • Increase in finger tapping rate of most affected side (back and forth between two counters, as explained in the Materials and Methods section)
  • Willing to hold PD meds each night for 3 days.
  • Symptoms of PD for at least 3 years, and on carbidopa/levodopa therapy for at least 1 year.
  • Subjects must be taking a minimum of 600mg of levodopa a day

Exclusion Criteria:

  • Severe limitation of downgaze, balance problems, history of early falling, or other signs suggestive of atypical parkinsonian syndrome.
  • Substantial history of cardiac or cerebrovascular disease that in the investigators' judgment would lead to risk of adverse outcomes.
  • Pregnancy or breast-feeding, or highly likely to become pregnant before the inpatient admission. Positive B-HCG at the time of the screening visit.
  • Age <35 or >85.
  • Hypotensive (i.e. sustained sitting sbp <95) or bradycardic (sustained hr <54) at the initial visit, or by history.
  • Very frequent and treatment refractory nausea and/or vomiting.
  • Sustained or significant hypokalemia or hypomagnesemia.
  • Refractory hypertension, as determined by the investigators.
  • Heavy alcohol use, as determined by clinical history of current alcoholism.
  • Renal failure or severe renal insufficiency as determined by the investigators.
  • Substantial hepatic impairment, by history or as determined by the investigators.
  • Hemoglobin <11 g/dl. Absolute neutrophils count <1000 per µl. Platelets <120,000 per µl.
  • Psychosis or use of antipsychotic medications. Current illicit drug abuse.
  • Mini mental status examination (MMSE) score < 24 so that they would be
  • Any medical or psychiatric condition that could pose a risk to the individual or compromise their ability to participate in the study.
  • Deep brain stimulator in place
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745277

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Parkinson Disease Research, Education and Clinical Center at Portland VA Hospital
RJG Foundation
Oregon Clinical and Translational Research Institute
Investigators
Principal Investigator: John G Nutt, MD Oregon Health and Science University
Principal Investigator: Jason Aldred, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: John G. Nutt, Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00745277     History of Changes
Other Study ID Numbers: eIRB#4133
Study First Received: September 2, 2008
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
carbidopa
levodopa
Parkinson's disease

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
Levodopa
Carbidopa, levodopa drug combination
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
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists

ClinicalTrials.gov processed this record on August 21, 2014