Parkinson's disease
Conditions
Sponsors
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Major inclusion criteria: - Patients must be able to understand and willing to sign an informed consent form (If the patient has difficulty in writing, his/her caregiver must sign an informed consent form). - Patients must have a diagnosis of Parkinson's disease meeting UK Parkinson's Disease Society Brain Bank diagnostic criteria. - Patients must have a modified Hoehn and Yahr stage of II-IV during an "off" phase at screening. - Patients must have been receiving treatment with any levodopa combination drug for more than 24 weeks at screening and have a wearing-off phenomenon with expected "off" time.
Exclusion criteria
Exclusion criteria: Major exclusion criteria: - The patient has a history of hypersensitivity or allergic response to selegiline. - The patient has had brain surgery etc. (thalamotomy, deep brain stimulation therapy etc.) as a treatment for his/her Parkinson's disease. - The patient has received transcranial magnetic stimulation therapy within the past 24 weeks. - The patient has a current clinically significant hepatic, renal, pancreatic, cardiovascular, endocrine, gastrointestinal, respiratory or nervous system disease (except Parkinson's disease). - The patient has received treatment with selegiline, pethidine, tramadol, tapentadol, reserpine and methyldopa within the past 12 weeks. - The female patient is pregnant, lactating or suspected of being pregnant. - The patient has previously received treatment with ME2125 (safinamide).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy "on" time Changes in mean daily "on" time from the baseline to 24 weeks of the treatment phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy "on" time, "off" time, Unified Parkinson's Disease Rating Scale (UPDRS), 39-item Parkinson's Disease Questionnaire (PDQ-39), responder rate, adverse event, adverse drug reaction, laboratory tests 1) Changes in mean daily "off" time from the baseline to 24 weeks of the treatment phase and each evaluation time point. 2) Changes in mean daily "on" time from the baseline to each evaluation time point. 3) Changes in UPDRS scores from the baseline to 24 weeks of the treatment phase and each evaluation time point. 4) Changes in total PDQ-39 score and each score from the baseline to 24 weeks of the treatment phase. 5) Responder rate at 24 weeks of the treatment phase. 6) The incidence of adverse events or adverse drug reactions. 7) Laboratory results at endpoint and each evaluation time point, and changes in these parameters from baseline. | — |
Countries
Japan
Outcome results
None listed