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

NCT ID: NCT00391898

Last Updated: 2011-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-06-30

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

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Levodopa/carbidopa/entacapone

Group Type: EXPERIMENTAL

Levodopa/carbidopa/entacapone

Intervention Type: DRUG

Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.

Levodopa/carbidopa

Group Type: ACTIVE_COMPARATOR

Levodopa/carbidopa

Intervention Type: DRUG

Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.

Interventions

Levodopa/carbidopa/entacapone

Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.

Intervention Type: DRUG

Levodopa/carbidopa

Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis Pharmaceuticals

Principal Investigators

Eduard Tolosa-Sarró, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínic i Provincial de Barcelona

Locations

Hospital Juan Canalejo

A Coruña, , Spain

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, , Spain

Fundación Hospital de Alcorcón

Alcorcón (Madrid, , Spain

Hospital General de Alicante

Alicante, , Spain

Centro Médico Teknon

Barcelona, , Spain

Hospital de la Santa Creu i de Sant Pau

Barcelona, , Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Corporació Sanitària Parc Taulí Sabadell

Barcelona, , Spain

Hospital General Yagüe

Burgos, , Spain

Policlínica Gipuzkoa

Donostia / San Sebastian, , Spain

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Hospital Universitari Bellvitge Princeps d'Espanya

L'Hospitalet de Llobregat , Barcelona, , Spain

Clínica Ruber

Madrid, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Fundación Jiménez Díaz

Madrid, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Universitaria de Navarra

Pamplona, , Spain

Hospital General de Catalunya

Sant Cugat Del Valles, Barcelona, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Mutua de Terrassa

Terrassa, Barcelona, , Spain

Hospital Universitario de la Fe

Valencia, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Hospital Gral. de Valencia

Valencia, , Spain

Countries

Spain

Other Identifiers

CELC200AES03

Identifier Type: -

Identifier Source: org_study_id