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

Novartis Pharmaceuticals0 sitesAugust 2008

ConditionsParkinson's Disease

Interventionscarbidopa/levodopa Carbidopa/Levodopa/Entacapone

Drugscarbidopa/levodopa Carbidopa/Levodopa/Entacapone

Overview

Phase: Phase 4
Intervention: carbidopa/levodopa
Conditions: Parkinson's Disease
Sponsor: Novartis Pharmaceuticals
Primary Endpoint: To evaluate the mean latency of the P300 component of the event-related potentials (ERPs) at four hours post study-drug administration
Status: Withdrawn
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

November 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

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
•dementia (of any cause);
•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
•generalized anxiety disorder or panic disorder if made prior to the diagnosis of PD.

Arms & Interventions

1

Immediate-Release Carbidopa/Levodopa

Intervention: carbidopa/levodopa

2

Carbidopa/Levodopa/Entacapone

Intervention: Carbidopa/Levodopa/Entacapone

Outcomes

Primary Outcomes

To evaluate the mean latency of the P300 component of the event-related potentials (ERPs) at four hours post study-drug administration

Secondary Outcomes

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