Status:
COMPLETED
Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
Lead Sponsor:
Novartis
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa
Eligibility Criteria
Inclusion
- Male and female patients ages ≥ 30 and ≤ 80 years old.
- A clinical diagnosis of idiopathic Parkinson's disease.
- Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.
- Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day.
- 1 full tablet, and/or
- 1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
- Must have early end-of-dose wearing-off defined by \>= 2 or \<=7 positive responses to the QUICK questionnaire.
- Must have a minimum UPDRS part II (ADL) score of 9.
- Patients without dyskinesia or with mild dyskinesia.
- Female patients must be either post-menopausal or using one or more acceptable methods of contraception.
- Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.
Exclusion
- Previous or current use of entacapone.
- History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
- Unstable Parkinson's disease patients.
- Patients who experience severe dyskinesia.
- The following levodopa/carbidopa doses and strengths are not permitted:
- Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
- Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
- Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
- Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
- Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
- Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit.
- Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
- Participated in another trial of an investigational drug/device within the last 30 days prior to study entry.
- Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00391898
Start Date
October 1 2006
End Date
June 1 2008
Last Update
March 15 2011
Active Locations (26)
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1
Hospital Juan Canalejo
A Coruña, Spain, 15002
2
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain, 28805
3
Fundación Hospital de Alcorcón
Alcorcón (Madrid, Spain, 28922
4
Hospital General de Alicante
Alicante, Spain, 03010