ME2125 Phase III (ME2125-4)
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCT2080223003
- Lead Sponsor
- Meiji Seika Pharma Co., Ltd.
- Brief Summary
The results of this study demonstrate that ME2125 50 and 100 mg/day, when administered for 52 weeks as an add-on therapy with levodopa combination drugs, is safe and tolerable and increases "on" time and improves motor function in "on" phase throughout the treatment period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 203
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse event, adverse drug reaction, Laboratory tests<br>1) The incidence of adverse events or adverse drug reactions.<br>2) Laboratory results at endpoint and each evaluation time point, and changes in these parameters from baseline.
- Secondary Outcome Measures
Name Time Method efficacy<br>on time, off time, Unified Parkinson's Disease Rating Scale (UPDRS), 39-item Parkinson's Disease Questionnaire (PDQ-39)<br>1) Changes in mean daily on time from the baseline to 52 weeks of the treatment phase<br>2) Changes in mean daily off time from the baseline to 52 weeks of the treatment phase and each evaluation time point<br>3) Changes in mean daily on time from the baseline to each evaluation time point<br>4) Changes in UPDRS scores from the baseline to 52 weeks of the treatment phase and each evaluation time point<br>5) Changes in total PDQ-39 score and each score from the baseline to 52 weeks of the treatment phase