Efficacy of Levodopa/Carbidopa/Entacapone vs. Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing Off

Condition(s) targeted: Parkinson's Disease

Intervention: Levodopa/carbidopa/entacapona (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Eduard Tolosa-Sarró, Dr., Principal Investigator, Affiliation: Hospital Clínic i Provincial de Barcelona

The study will evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in patients with Parkinson's disease and early wearing off with levodopa

Official title: A 3-Month, Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs. Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing Off With Levodopa

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Unified Parkinson Disease Rating Scale score, Part II (Activities of daily living) at the beginning of the study and at 3 months

Secondary outcome:

Unified Parkinson Disease Rating Scale scores parts I (Mentation, behavior and mood), III (Motor examination), IV (Complications of the treatment) and total score at the beginning of the study and at 3 months

Parkinson Disease Questionnaire-39 items at the beginning of the study and at 3 months

Global assessments of the treatment, by patient and investigator, at baseline and 3 months

Detailed description: The study will evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in patients with Parkinson's disease and early wearing off with levodopa

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male and female patients ages ≥ 30 and ≤ 80 years old.

2. A clinical diagnosis of idiopathic Parkinson's disease.

3. Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.

4. 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.

5. Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.

6. Must have a minimum UPDRS part II (ADL) score of 9.

7. Patients without dyskinesia or with mild dyskinesia.

8. Female patients must be either post-menopausal or using one or more acceptable methods of contraception

9. 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 Criteria:

1. Previous or current use of entacapone.

2. History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.

3. Unstable Parkinson's disease patients

4. Patients who experience severe dyskinesia

5. 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)

6. Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.

7. Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.

8. Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit

9. Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis

10. Participated in another trial of an investigational drug/device within the last 30 days prior to study entry

11. Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements

Hospital Clínic i Provincial de Barcelona, Barcelona 08036, Spain

Universitaria de Navarra, Pamplona 31008, Spain

Policlínica Gipuzkoa, San Sebastian 20009, Spain

Hospital Universitari Bellvitge Princeps d'Espanya, L'Hospitalet de Llobregat , Barcelona 08907, Spain

Hospital General de Catalunya, Sant Cugat del Valles, Barcelona 08195, Spain

Hospital Vall d'Hebron, Barcelona 08025, Spain

Hospital Mutua de Terrassa, Terrassa, Barcelona 08221, Spain

Centro Médico Teknon, Barcelona 08022, Spain

Hospital de la Santa Creu i de Sant Pau, Barcelona 08025, Spain

Hospital Universitario de la Fe, Valencia 46009, Spain

Hospital Clínico San Carlos, Madrid 28040, Spain

Clínica Ruber, Madrid 28006, Spain

Hospital General Universitario Gregorio Marañon, Madrid 28007, Spain

Hospital Universitario Principe de Asturias, Alcalá de Henares, Madrid 28805, Spain

Fundación Hospital de Alcorcón, Alcorcón (Madrid 28922, Spain

Hospital Universitario La Paz, Madrid 28046, Spain

Hospital Universitario Virgen del Rocio, Sevilla 41013, Spain

Hospital Universitario Virgen de las Nieves, Granada 18012, Spain

Hospital General de Alicante, Alicante 03010, Spain

Hospital General Yagüe, Burgos 09005, Spain

Hospital Juan Canalejo, La Coruña 15002, Spain

Fundación Jiménez Díaz, Madrid 28040, Spain

Hospital Clínico Universitario de Valencia, Valencia 46010, Spain

Hospital 12 de Octubre, Madrid 28041, Spain

Hospital Gral. de Valencia, Valencia 46014, Spain

Corporació Sanitària Parc Taulí Sabadell, Barcelona 08208, Spain

Starting date: October 2006
Ending date: June 2008
Last updated: June 6, 2008