Parkinson disease
Conditions
Interventions
Trade Name: Stalevo
Product Code: ELC200
Pharmaceutical Form: Capsule*
INN or Proposed INN: levodopa/carbidopa/entacapone
Current Sponsor code: ELC200
Concentration unit: mg milligram(s)
Concentration
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female, Idiopathic Parkinson's disease with at least 2 cardinal signs of disease, aged 30 to 80 years, inclusive, at time of PD, Total UPDRS Part II and III greater than or equal to 18 at Screening and Baseline visits, Modified Hoehn and Yahr stage 1.0 to 2.5, PD impairement warranting treatment with Levodopa, Willing and able to give written informed consent, willing and able to comply with study procedures, availability of a caregiver/family informant. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. history, signs or symptoms suggesting the diagnosis of atypical or secondary Parkinsonism due to drugs, metabolic disorders, encephalitis, or other neurodegenerative diseases 2. 2. History of stereotaxic brain surgery for PD (e.g., pallidotomy, deep brain stimulation, tissue transplant) 3. Diagnosis of Parkinson’s disease for more than 5 years prior to Screening 4. Mini-Mental State Exam (MMSE) score less than or equal to 26 at Screening 5. Beck Depression Inventory (BDI) score greater than or equal to 15 at Screening 6. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrences or metastases, with the exception of localized basal cell carcinoma of the skin 7. History of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis, suspicious undiagnosed skin lesion, narrow angle glaucoma, or pheochromocytoma 8. Any other known medical or psychiatric condition that may compromise the patient’s participation in this study, confound the interpretation of the data, or necessitate the use of medications not allowed by this protocol 9. Clinically significant ECG abnormality 10. Patients with a history of laboratory abnormality consistent with, or other evidence of medical disease (i.e., cardiovascular, hepatic, renal, etc.), which may impair reliable participation in the study, or confound the interpretation of the data, or necessitate the use of medications not allowed by this protocol 11. Nursing (lactating) women 12. Women of child-bearing potential (WOCBP) etc....
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that Stalevo provides superior symptomatic benefit compared with standard carbidopa/levodopa administered at the same Levodopa dosage as assessed by parts II and III of the Unified Parkinson's Disease Rating scale (UPDRS), the standard symptomatic rating scale used to assess patients with PD.;Secondary Objective: To demonstrate that Stalevo provides superior symptomatic benefit compared with standard carbidopa/levodopa administered at the same levodopa dosage as assessed by individual UPDRS subscale scores (Subscale II- ADL (Activities of daily Living) and Subscale III- Motor), PDQ-39 (overall score and individual domain scores), Modified Hoehn and Yahr stage scores (UPDRS PartV), Schwab and England ADL Scale scores (UPDRS Part VI), Clinical Global Impression Scale scores, incidence of dyskinesia and wearing-off and that the safety and tolerability of Stalevo is comparable to that of carbidopa/levodopa including an assessment of UPDRS individual subscale scores for Part I - mentation, Behavior and Mood.;Primary end point(s): The primary outcome variable is the change from baseline to week 39 in the total score on the Unified Parkinson’s Disease Rating Scale (UPDRS), Parts II and III. UPDRS Parts I and II are collected by questioning the patients. Parts III, V and VI are assessed by examination. Part IV will not be completed. Parts I - III, V, and VI will be completed at each study visit. | — |
Countries
Czech Republic, Italy, Portugal
Outcome results
None listed