Parkinson's disease MedDRA version: 12.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's
Conditions
Interventions
Product Name: carbidopa 20 mg
Product Code: NA
Pharmaceutical Form: Capsule*
INN or Proposed INN: CARBIDOPA
CAS Number: 38821-49-7
Current Sponsor code: NA
Other descriptive name: NA
Concentration uni
Sponsors
Orion Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent (IC) obtained. 2.Male or female patients with idiopathic PD according to the United Kingdom brain bank criteria with end-of-dose motor fluctuations 3. Hoehn and Yahr stage 2-4 performed during the “ON” state. 4. Duration of response between 1.5 and 4 hours (based on medical history) to the patient’s first morning dose of levodopa/dopa decarboxylase inhibitor (DDCI) with or without entacapone. 5. Treatment with 3-8 daily doses of levodopa/DDCI with or without entacapone with a total daily levodopa dose in the range of 300-1200 mg. One evening dose of controlled-release formulation of levodopa/DDCI is allowed provided that it is included in the total of 3-8 daily doses of levodopa/DDCI mentioned above. 6. Unchanged levodopa/DDCI with or without entacapone and other antiparkinsonian medication (dopamine agonists, monoamine oxidase [MAO] B inhibitor, amantadine and/or anticholinergics with approved doses), if any, for at least 6 weeks prior to the screening visit. 7. Age of 30 years or above. 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. Secondary or atypical parkinsonism. 2. Use of tolcapone within 6 weeks prior to the first treatment period. 3. Previous tolerability problems with entacapone or tolcapone. 4. Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors. 5. Concomitant treatment with drugs having antidopaminergic action including alpha-methyldopa, reserpine and antipsychotic drugs (also D2 receptor blocking antiemetics except domperidone). As an exception, an evening dose of an atypical antipsychotic is allowed. 6. Use of any iron preparations. 7. Intensity of dyskinesias which would, in the opinion of the investigator, interfere with the interpretation of motor part (part III) of the Unified Parkinson’s Disease Rating Scale (UPDRS III) scoring during the levodopa challenge test. 8. Currently active hallucinations. 9. Severe orthostatic hypotension as judged by the investigator. 10. Mini-Mental State Examination (MMSE) score upper limit of normal at screening. 17. Any other abnormal value of laboratory, vital signs or electrocardiogram (ECG) which would in the opinion of the investigator interfere with the interpretation of the study results or cause health risk for the subject if he/she takes part into the study. 18. Female patients of childbearing potential (i.e. menstruating or less than 2 years postmenopausal) if they are not using proper contraception (hormonal contraception, intrauterine device [IUD] or surgical sterilisation, spermicidal foam in conjunction with condom on male partner). 19. Patients with pre-planned elective surgery. 20. Known hypersensitivity to active substances or to any of the excipients of the study drugs. 21. Participation in a drug study within 60 days prior to entry to this study. 22. Any other condition that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective is to evaluate the safety of the L/C/E treatment regimens in patients with PD. ;Main Objective: The primary objective is to assess the effect of a single dose of two experimental levodopa/carbidopa/entacapone (L/C/E) treatment regimens versus standard L/C/E treatment regimen in Parkinson’s disease (PD) patients with end-of-dose motor fluctuations in terms of duration of motor response after the first morning dose of levodopa. ;Primary end point(s): Duration of motor response to levodopa (“ON”-time), as determined using the UPDRS III. The start of the response will be defined as when the UPDRS III score shows a 10% reduction from the baseline, and it will be considered to have ended when the UPDRS III score is returned to within 10% of the baseline. UPDRS III will be assessed twice, 20 minutes apart, after administration of the carbidopa/placebo capsules but before administration of Stalevo. After administration of Stalevo, UPDRS III will be assessed at every 20 minutes until the patient has turned “OFF” or up to a maximum of 6 hours. | — |
Countries
Finland, Sweden
Outcome results
None listed