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

Phase 4

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Levodopa/carbidopa; Drug: Levodopa/carbidopa/entacapone

• Registration Number: NCT00391898
• Lead Sponsor: Novartis

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-24
• Study First Posted: 2006-10-25
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2011-01-04
• Status Verified: 2011-02
• Results First Submitted QC: 2011-02-16
• Last Update Submitted: 2011-02-16
• Results First Posted: 2011-03-15
• Last Update Posted: 2011-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levodopa/carbidopa	Levodopa/carbidopa	-
Levodopa/carbidopa/entacapone	Levodopa/carbidopa/entacapone	-

Primary Outcome Measures

Name	Time	Method
Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3	Baseline to end of study (Month 3)	The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52, calculated as the sum of the individual items) measures the patient's activities of daily living. A lower total score indicates greater symptom control. A negative change score indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3	Baseline to end of study (Month 3)	Part IV of the UPDRS measures complications the patient may be experiencing with therapy and was only collected at and after the visit at which the first dyskinesia or episode of wearing-off was recorded. Part IV is composed of 3 sections and 11 items: A (32-35, dyskinesia), B (36-39, clinical fluctuations, C (40-42, other complications) (total score 0-23, calculated as the sum of the individual items). A lower total score indicates greater symptom control. A negative change score indicates improvement.
Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3	Baseline to end of study (Month 3)	The PDQ-39 is an instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognitions, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 195. A lower score indicates better quality of life. A positive change score indicates an improvement.
Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3	Baseline to end of study (Month 3)	The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part I (items 1-4; total score 0-16, calculated as the sum of the individual items) measures the patient's mentation, mood and behavior. A lower total score indicates greater symptom control. A negative change score indicates improvement.
Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3	Baseline to end of study (Month 3)	The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part III (items 18-31; total score 0-56, calculated as the sum of the individual items) measures the patient's motor function. A lower total score indicates greater symptom control. A negative change score indicates improvement.
Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3	Baseline to end of study (Month 3)	The QQ is a self-administered questionnaire that includes 19 wearing-off (WO) symptoms (motor and non-motor). A positive answer to each of the 19 symptoms is given by patients if they presented with a symptom and the symptom disappeared after the next drug dose. Two positive answers are diagnostic of wearing-off (WO). A negative change score indicates improvement.
Patient and Investigator Global Evaluation of the Patient	Baseline to end of study (Month 3)	Both the patient and the investigator made an evaluation of the change in the patient's condition by rating the condition of the patient at the end of the study compared to patient's condition at baseline. The rating was made on a scale ranging from -3 to +3: (-3: Very much improved, -2: much improved, -1: mild improvement, 0: no change, +1: mild deterioration, +2: much deterioration, +3: very much deterioration). A negative score indicates improvement.

Trial Locations

Locations (26)

Fundación Hospital de Alcorcón; 🇪🇸 Alcorcón (Madrid, Spain

Centro Médico Teknon; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Principe de Asturias; 🇪🇸 Alcalá de Henares, Madrid, Spain

Hospital General de Alicante; 🇪🇸 Alicante, Spain

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Corporació Sanitària Parc Taulí Sabadell; 🇪🇸 Barcelona, Spain

Hospital Juan Canalejo; 🇪🇸 La Coruña, Spain

Clínica Ruber; 🇪🇸 Madrid, Spain

Hospital General Yagüe; 🇪🇸 Burgos, Spain

Hospital Universitari Bellvitge Princeps d'Espanya; 🇪🇸 L'Hospitalet de Llobregat , Barcelona, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital General Universitario Gregorio Marañon; 🇪🇸 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 Universitario Virgen del Rocio; 🇪🇸 Sevilla, Spain

Policlínica Gipuzkoa; 🇪🇸 San Sebastian, Spain

Hospital Universitario de la Fe; 🇪🇸 Valencia, Spain

Hospital General de Catalunya; 🇪🇸 Sant Cugat del Valles, Barcelona, Spain

Hospital Mutua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Gral. de Valencia; 🇪🇸 Valencia, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain