Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off
Primary Purpose
Parkinson's Disease
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
carbidopa/levodopa
Carbidopa/Levodopa/Entacapone
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, carbidopa/levodopa/entacapone, carbidopa/levodopa, non-motor symptoms, event-related potential, ERP, EEG, electroencephalogram
Eligibility Criteria
Inclusion Criteria:
- Male or female patients aged 45 to 75 years (inclusive)
- Patients with an MMSE score of at least 25 at the screening visit.
- Patients who experience EODWO, which is the re-emergence of PD symptoms during the waking hours, as determined by a WOQ-9 score of at least one motor symptom of wearing off
- Patients taking a stable dose of immediate-release carbidopa/levodopa for at least 4 weeks prior to randomization, at an equivalent total daily dose of levodopa between 300 to 600 mg/day.
- Patients who, in the investigator's judgement, are capable of satisfying the requirements of the protocol
- Patients who are willing and able to give written informed consent according to legal requirements.
Exclusion Criteria:
- Diagnosis of secondary parkinsonism, atypical Parkinson's disease, or history, signs, or symptoms suggesting these diagnoses.
- Unstable Parkinson's disease as determined by the investigator.
- Disabling dyskinesia (a score of >2 on the Unified Parkinson's Disease Rating Scale [UPDRS] question #32, or a score of >2 on UPDRS question #33).
- Treatment with carbidopa/levodopa controlled-release or extended-release formulations (bedtime administration is acceptable). The use of controlled-release carbidopa/levodopa is not allowed on the evening before the visits in which efficacy assessments occur.
- Concomitant or previous treatment with certain medications or supplements as specified in the protocol.
- Patients who are unable to comply with the dosing requirements of the protocol, such that the first dose of study medication will be taken after the time of the first EEG and the second dose will be taken after completion of the third EEG.
- Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR; diagnosis of 1. dementia (of any cause); 2. moderate or severe major depression, present independent from the time of first diagnosis of PD, as defined by a QIDS-SR16 score of > 15; or 3. generalized anxiety disorder or panic disorder if made prior to the diagnosis of PD.
- DSM-IV-TR diagnosis of alcohol or substance abuse (excluding nicotine or caffeine) during the 3 months prior to randomization) or alcohol or substance dependence (excluding nicotine or caffeine) during the 6 months prior to randomization. Alcohol should be avoided within the 12 hours preceding the Week 6 and Week 12 visits.
- Nicotine use of >5 cigarettes (or equivalent in other forms of administration) per day. Nicotine use will not be permitted on the day of the Week 6 and Week 12 visits.
- Ingestion of >4 caffeinated beverages (or equivalent in other forms of administration) per day.
- History of major head injury, including skull fracture or a penetrating head injury, or a history of brain surgery.
- Past or current treatment by deep brain stimulation.
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- Hearing loss or impairment that may prevent reliability of test results using auditory evoked potentials.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Immediate-Release Carbidopa/Levodopa
Carbidopa/Levodopa/Entacapone
Outcomes
Primary Outcome Measures
To evaluate the mean latency of the P300 component of the event-related potentials (ERPs) at four hours post study-drug administration
Secondary Outcome Measures
Mean latency of the P300 component of ERPs at pre-dose and 1 hours post-dose study drug administration
Mean latency of the N100 component of ERPs at pre-dose, 1 hour post-dose and 4 hours post-dose study drug administration
Pharmacokinetics at 9.25 and 12.55 hours post dose
Full Information
NCT ID
NCT00601978
First Posted
January 11, 2008
Last Updated
April 27, 2012
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00601978
Brief Title
Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off
Official Title
A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing Off
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision brand strategy; no patients enrolled
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the effects of immediate release (IR) carbidopa levodopa versus the effects of immediate-release carbidopa/levodopa on ERP parameters in patients with idiopathic PD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, carbidopa/levodopa/entacapone, carbidopa/levodopa, non-motor symptoms, event-related potential, ERP, EEG, electroencephalogram
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Immediate-Release Carbidopa/Levodopa
Arm Title
2
Arm Type
Active Comparator
Arm Description
Carbidopa/Levodopa/Entacapone
Intervention Type
Drug
Intervention Name(s)
carbidopa/levodopa
Intervention Type
Drug
Intervention Name(s)
Carbidopa/Levodopa/Entacapone
Other Intervention Name(s)
Stalevo
Primary Outcome Measure Information:
Title
To evaluate the mean latency of the P300 component of the event-related potentials (ERPs) at four hours post study-drug administration
Secondary Outcome Measure Information:
Title
Mean latency of the P300 component of ERPs at pre-dose and 1 hours post-dose study drug administration
Title
Mean latency of the N100 component of ERPs at pre-dose, 1 hour post-dose and 4 hours post-dose study drug administration
Title
Pharmacokinetics at 9.25 and 12.55 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients aged 45 to 75 years (inclusive)
Patients with an MMSE score of at least 25 at the screening visit.
Patients who experience EODWO, which is the re-emergence of PD symptoms during the waking hours, as determined by a WOQ-9 score of at least one motor symptom of wearing off
Patients taking a stable dose of immediate-release carbidopa/levodopa for at least 4 weeks prior to randomization, at an equivalent total daily dose of levodopa between 300 to 600 mg/day.
Patients who, in the investigator's judgement, are capable of satisfying the requirements of the protocol
Patients who are willing and able to give written informed consent according to legal requirements.
Exclusion Criteria:
Diagnosis of secondary parkinsonism, atypical Parkinson's disease, or history, signs, or symptoms suggesting these diagnoses.
Unstable Parkinson's disease as determined by the investigator.
Disabling dyskinesia (a score of >2 on the Unified Parkinson's Disease Rating Scale [UPDRS] question #32, or a score of >2 on UPDRS question #33).
Treatment with carbidopa/levodopa controlled-release or extended-release formulations (bedtime administration is acceptable). The use of controlled-release carbidopa/levodopa is not allowed on the evening before the visits in which efficacy assessments occur.
Concomitant or previous treatment with certain medications or supplements as specified in the protocol.
Patients who are unable to comply with the dosing requirements of the protocol, such that the first dose of study medication will be taken after the time of the first EEG and the second dose will be taken after completion of the third EEG.
Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR; diagnosis of 1. dementia (of any cause); 2. moderate or severe major depression, present independent from the time of first diagnosis of PD, as defined by a QIDS-SR16 score of > 15; or 3. generalized anxiety disorder or panic disorder if made prior to the diagnosis of PD.
DSM-IV-TR diagnosis of alcohol or substance abuse (excluding nicotine or caffeine) during the 3 months prior to randomization) or alcohol or substance dependence (excluding nicotine or caffeine) during the 6 months prior to randomization. Alcohol should be avoided within the 12 hours preceding the Week 6 and Week 12 visits.
Nicotine use of >5 cigarettes (or equivalent in other forms of administration) per day. Nicotine use will not be permitted on the day of the Week 6 and Week 12 visits.
Ingestion of >4 caffeinated beverages (or equivalent in other forms of administration) per day.
History of major head injury, including skull fracture or a penetrating head injury, or a history of brain surgery.
Past or current treatment by deep brain stimulation.
History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
Hearing loss or impairment that may prevent reliability of test results using auditory evoked potentials.
12. IPD Sharing Statement
Learn more about this trial
Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off
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