A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off.

• Conditions: Idiopathic Parkinson’s disease and end-of-dose wearing off.; MedDRA version: 9.1Level: LLTClassification code 10061536Term: Parkinson's disease

• Registration Number: EUCTR2007-003134-42-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-20
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male or female patients aged 45 to 75 years (inclusive).
2. Patients with an MMSE score of at least 25 at the screening visit.
3. Patients who experience EODWO, defined as 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. An item is considered positive when it is present and when the referring symptomatology improves with the next dose of dopaminergic medication.
4. 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.
5. Patients who, in the investigator’s judgement, are capable of satisfying the
requirements of the protocol.
6. Patients who are willing and able to give written informed consent according to legal requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosis of secondary parkinsonism, atypical Parkinson’s disease, or history, signs, or symptoms suggesting these diagnoses.
2. Unstable Parkinson’s disease as determined by the investigator.
3. 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).
4. Treatment with carbidopa/levodopa controlled-release or extended-release formulations (bedtime administration is acceptable). The use of controlled-release Sinemet is not allowed on the evening before the visits in which efficacy assessments occur.
5. Treatment with <3 or >4 daily doses of immediate release carbidopa/levodopa of any dose form within 4 weeks (28 days) prior to randomization (this allows combination of different strengths).
6. Patients requiring less than three levodopa/carbidopa doses per day
7. 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.
8. Treatment with monoamine oxidase type A (MAO-A) inhibitors or neuroleptics,
within 60 days prior to the randomization.
9. Treatment with selegiline or rasagiline within 4 weeks (28 days) prior to
randomization.
10. Concomitant treatment with dopamine agonists or catechol O-methyltransferase
(COMT) inhibitors within 4 weeks ( 28 days) of randomization), or at any time in the
past if, in the perspective of a treating physician, the patient experienced serious or
severe adverse event(s) or treatment failure that resulted in the discontinuation of
treatment)
11. Current treatment with anticoagulants. Aspirin taken for health or cardiac prophylaxis will be permitted, provided that the total daily dose does not exceed 81 mg.
12. Treatment with a benzodiazepine or any sleep medication. As needed use of these medications will be permitted; however, they may not be administered during the 48 hours prior to the Week 6 or Week 12 visits.
13. Use of magnesium supplements within 4 weeks (28 days) prior to randomization.
14. Treatment with angiotensin-converting enzyme (ACE)-inhibitors within 28 days prior to randomization.
15. Treatment with oral or inhaled glucocorticoids (topical preparations are permitted) within 3 months prior to randomization.

Please refer to the enclosed protocol for a detailed description of all exclusion criterias.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified