| October 24, 2006 |
| June 6, 2008 |
| October 2006 |
| |
| Unified Parkinson Disease Rating Scale score, Part II (Activities of daily living) at the beginning of the study and at 3 months |
| Same as current |
| Complete list of historical versions of study NCT00391898 on ClinicalTrials.gov Archive Site |
- 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
|
| Same as current |
| |
| Efficacy of Levodopa/Carbidopa/Entacapone vs. Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing Off |
| 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 |
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 |
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 |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Parkinson's Disease |
| Drug: Levodopa/carbidopa/entacapona |
- Experimental: Levodopa/carbidopa/entacapone
- Active Comparator: Levodopa/carbidopa
|
| |
| |
| Active, not recruiting |
| 200 |
| June 2008 |
|
Inclusion Criteria:
- 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 Criteria:
- 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
|
| Both |
| 30 Years to 80 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Spain |
| |
| NCT00391898 |
| External Affairs, Novartis Pharmaceuticals |
| CELC200AES03 |
| Novartis |
|
| Principal Investigator: |
Eduard Tolosa-Sarró, Dr. |
Hospital Clínic i Provincial de Barcelona |
|
|
| Novartis |
| June 2008 |