Parkinson’s disease MedDRA version: 8.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Sponsors
Orion Corporation Orion Pharma, FI-02200 Espoo, Finland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained. 2. Male or female subjects with idiopathic PD and early WO symptoms treated with standard levodopa/DDCI treatment. 3. Hoehn and Yahr stage 1-3 performed during the ‘ON’-state. 4. Age = 35 years. 5. At least 1 symptom identified by WOQ-9. 6. Dosing frequency of 3-4 daily doses of standard-release levodopa/DDCI maximum total daily dose of 600 mg of standard-release levodopa). 7. Unchanged levodopa/DDCI and other antiparkinsonian medication (amantadine, selegiline up to 10 mg/day, rasagiline up to 1 mg/day, anticholinergics and/or dopamine agonists), if any, for at least 6 weeks preceding baseline (V1). 8. Willingness to change his/her current regimen of levodopa/DDCI due to the identified WO symptom(s) to an equivalent dose of Stalevo®. 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. Atypical or symptomatic parkinsonism. 2. Unpredictable OFF-periods. 3. Any peak-dose dyskinesia. ‘OFF’-state dystonia is allowed. 4. Use of more than 1 evening dose of controlled-release (CR) levodopa/DDCI. 5. Use of any rescue medications to treat symptoms of ‘OFF’-state. 1 dose of soluble levodopa/DDCI as the first morning dose is allowed. 6. Concomitant treatment with non-selective monoamine oxidase (MAO) inhibitor or simultaneous use of higher than recommended doses of MAO-A and MAO-B inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine. 7. Concomitant treatment with drugs having antidopaminergic action, including alphamethyldopa, reserpine and antipsychotic drugs (also D2 receptor blocking antiemetics, except domperidone). As an exception to prohibited use of antipsychotic drugs, 1 daily dose of clozapine or quetiapine at night is allowed. 8. Clinically significant (e.g. cardiovascular, hepatic, renal, pulmonary, gastrointestinal neurological or psychiatric) disorder, which may influence the outcome of the study. 9. History of narrow-angle glaucoma, pheochromocytoma, neuroleptic malignant syndrome (NMS) and/or rhabdomyolysis. 10. Current malignancy. 11. Severe hepatic impairment. 12. Any abnormal laboratory value with clinical relevance. 13. Any abnormal electrocardiogram (ECG) finding with clinical relevance. 14. Female subjects must be either not of child-bearing potential (defined as postmenopausal for at least 2 years or surgically incapable of bearing children), or must be practicing one or more of the following methods of contraception during the study: intrauterine device or barrier method in combination with spermicide. Use of oral/hormonal contraception is acceptable only when combined with barrier method. 15. Pregnancy and lactation. 16. Treatment with a Catechol-O-Methyltransferase (COMT) inhibitor within the last 6 weeks. 17. Known previous adverse drug reaction (ADR) or hypersensitivity to a COMT inhibitor. 18. Participation in any other clinical studies within 30 days prior to study entry or earlier treatment with Stalevo®. 19. Past or current treatment by deep brain stimulation (DBS) or other surgical treatment for Parkinson's disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to provide efficacy data of the direct switch from levodopa/carbidopa or levodopa/benserazide to levodopa/carbidopa/entacapone (Stalevo®) by clinical global impression of change (CGI-C) as judged by the subject him/herself.;Secondary Objective: - to study the change in subject’s clinical condition by CGI-C as judged by the investigator - to study the change in subject’s clinical condition by change of Unified Parkinson’s Disease Rating Scale (UPDRS) II (activity of daily living) and UPDRS III (motor disability) - to investigate the QoL at baseline and the change from baseline at the end of the study by a QoL visual analogue scale (VAS) - to study the effect of Stalevo® on motor and non-motor WO symptoms. An additional objective is to study the change in the daily levodopa dose and the number of daily doses. ;Primary end point(s): Switch-related efficacy from baseline assessed by the patient’s CGI-C at visit V5 (6 weeks)/premature discontinuation. | — |
Countries
Germany, Sweden, United Kingdom
Outcome results
None listed