Early Parkinson's disease
Conditions
Sponsors
FP Pharmaceutical Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria Parkinson's disease patients who have no history of previous treatment with anti-Parkinson's disease drugs Within five years after onset of motor symptoms Modified Hoehn & Yahr rating stage I - III UPDRS part III total score 10 or greater
Exclusion criteria
Exclusion criteria: Main exclusion criteria Patients taking the drugs designated in the exclusion criteria during a certain period of time before starting administration of the investigational drug Patients complicated with serious neurological and mental disorders (e.g. disturbed consciousness, hallucination, delusion, abnormal behaviors, etc.) Patients under epilepsy treatment Patients with advanced complications in the cardiovascular system, liver, kidney, blood or other organs Patients with complication or history of schizophrenia Patients with dependence on CNS stimulants (e.g. amphetamines, cocaine, etc.) or with such history Patients during pregnancy or lactation, or patients who wish to get pregnant during the study Patients who participated in any study using selegiline in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change fom baseline in the sum of UPDRS part I, II and III | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change from baseline in each score of UPDRS part I, II, III and IV (2) Change from baseline in the sum of UPDRS part II and III (3) Proportion of responders defined with the sum of UPDRS part I, II and III (4) Proportion of responders defined with the sum of UPDRS part II and III (5) Modified Hoehn & Yahr rating stage (6) Clinical Global Impression of Improvement (CGI-I) | — |
Outcome results
None listed