Clinical trial NCT00391898: Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
Official title: A 3-month, Multi-center, 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-25
Enrollment: 95
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3
timeFrame: Baseline to end of study (Month 3)
Secondary outcomes:
measure: Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3
timeFrame: Baseline to end of study (Month 3)
measure: Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3
timeFrame: Baseline to end of study (Month 3)
measure: Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3
timeFrame: Baseline to end of study (Month 3)
measure: Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3
timeFrame: Baseline to end of study (Month 3)
measure: Patient and Investigator Global Evaluation of the Patient
timeFrame: Baseline to end of study (Month 3)
measure: Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3
timeFrame: Baseline to end of study (Month 3)
Other outcomes:
Locations:
city: Alcalá de Henares, Madrid
country: Spain
facility: Hospital Universitario Principe de Asturias
city: Alcorcón (Madrid
country: Spain
facility: Fundación Hospital de Alcorcón
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Centro Médico Teknon
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i de Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Corporació Sanitària Parc Taulí Sabadell
city: Burgos
country: Spain
facility: Hospital General Yagüe
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: L'Hospitalet de Llobregat , Barcelona
country: Spain
facility: Hospital Universitari Bellvitge Princeps d'Espanya
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Madrid
country: Spain
facility: Clínica Ruber
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pamplona
country: Spain
facility: Universitaria de Navarra
city: San Sebastian
country: Spain
facility: Policlínica Gipuzkoa
city: Sant Cugat del Valles, Barcelona
country: Spain
facility: Hospital General de Catalunya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Terrassa, Barcelona
country: Spain
facility: Hospital Mutua de Terrassa
city: Valencia
country: Spain
facility: Hospital Universitario de la Fe
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Gral. de Valencia
Study officials:
affiliation: Hospital Clínic i Provincial de Barcelona
name: Eduard Tolosa-Sarró, Dr.
role: PRINCIPAL_INVESTIGATOR
References: