None listed
Conditions
Interventions
Group 1 Type of group
50mg safinamide orally for 24 weeks
Group name:Group 3 Type of group
placebo orally for 24 weeks
Sponsors
MERCK SERONO INTERNATIONAL S.A.,
Eligibility
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Have a diagnosis of idiopathic Parkinson´s disease less than 5 years old, with stage I-III of Hoehn & Yahr. The diagnosis must be based on the clinical history and the neurological examination. • Be between 30 and 80 years of age, inclusive, at the time of selection. • In the case of women, being post-menopausal for at least 2 years, being surgically sterilized or having undergone a hysterectomy, or, in the case of women with the capacity to procreate, be willing to avoid pregnancy through the use of an appropriate contraceptive method as defined in Section 6.4.9 during the previous four weeks [at the start of treatment], during the same, and for the four weeks following the last dose of study medication. For the purposes of this study, women with the capacity to procreate all female subjects who have gone through puberty, unless they have been post-menopausal for at least two years, have been surgically sterilized or sexually inactive. • Be receiving treatment with a single dopamine agonist in a stable dose for at least 4 weeks before the screening visit. • Have the willingness and ability to participate in the study and have provided written informed consent.
Exclusion criteria
Exclusion criteria: • Any indication of any form of Parkinson´s disease, other than idiopathic Parkinson´s disease. • In the case of women, pregnancy or breastfeeding. • Current diagnosis of substance abuse or history of alcoholism or drug abuse in the last 3 months. • Currently experiencing phenomena of dissipation of the therapeutic effect of the final dose or on-off phenomena, biphasic dyskinesias or peak of incapacitating doses, or unpredictable or widely variable fluctuations. • Currently affected by a clinically significant disease of the gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular type, including acute gastric ulcer, inadequately controlled hypertension, asthma, chronic obstructive pulmonary disease (COPD) and type I diabetes. with a history of gastric ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion. • Second or third degree atrio-ventricular block or sick sinus syndrome, uncontrolled uricular fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months prior to the screening visit, or abnormalities significant in the ECG, including QTc> 450 msec (men) or> 470 msec (women), in which case the QTc is based on the Bazett correction method. • Have previously received treatment with safinamide. • A concomitant disease that is likely to interfere with the study medication (eg, capable of altering the absorption, metabolism, or elimination of the study drug). • History of, or current picture of, psychosis (eg, schizophrenia or psychotic depression), or a score> 3 on item 2 (thought disorder) or on item 3 (depression) of UPDRS Section I in the moment of selection. • Evidence of dementia or cognitive dysfunction, indicated by a score in the MMSE 3 in item 1 (mental state) of the UPDRS, Section I at the time of selection. • Depression, indicated by a score> 17 in the GRID-HAMD (scale of 17 items) at the time of selection. • History of allergic response to anticonvulsants or antiparkinsonians. • Mental or physical disorder (eg, neurotic behavior, disabling degenerative arthritis, or limb amputation) that could impede effectiveness or safety evaluations. • Hypersensitivity or contraindications to MAO-B inhibitors. • Current history of severe dizziness or fainting when standing up, as a consequence of postural hypotension. • Neoplastic disorder, which is active or has been in remission for less than a year. • Participation in a clinical study within 30 days before entering the study (screening visit) or having received treatment with a compound under investigation within 30 days or 5 half-lives, which implies a longer period, prior to the selection. • Treatment of your Parkinson´s symptoms with a medication, other than a stable dose of a single dopamine agonist, during the 8 weeks prior to the screening visit. • Treatment with any agent known to cause significant inhibition or induction of the drug´s metabolizing enzymes (eg, barbiturates, phenothiazines, etc.) within 4 weeks prior to the screening visit. • Treatment with opioids (eg, tramadol, meperidine derivatives), ISRN (eg, venlafaxine, duloxetine), tri- or tetra-cyclic antidepressants, MAO inhibitors (eg, selegiline) , within 8 weeks prior to the screening visit. The use of dextromethorphan will be allowed if it is for the treatment of cough. • T
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A hierarchical procedure (20) will be used to compare the primary parameter between each dose of safinamide and placebo. First the dose of safmamide 100 mg / day will be compared with placebo. If this comparison is statistically significant, then the dose of safinamide 50 mg / day will be compared with placebo; otherwise, comparison of the dose of safinamide 50 mg / day with placebo will not be made. Measure:Change in the score of UPDRS Section III from baseline to week 24 Timepoints:week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The UPDRS is a qualification tool used to follow the longitudinal evolution of Parkinsons disease. It is made up of four sections that evaluate the following: Section I - Mental state, behavior and state of mind; Section II - Activities of daily life; Section III - Motor Test; and Section IV - Complications of therapy. Measure:Change in the score of the UPDRS Section II (ADL) between baseline and week 24. Timepoints:week 24 ; Outcome name:Cognitive function will be evaluated through a computerized battery of tests, the battery for Cogtest® EP, with tests specially selected for patients with Parkinsons disease. The Cogtest® Console captures information about the participant and about the study (similar to an electronic CRF) and is customized according to the requirements of each particular clinical study. Measure:Change in battery score for EP Cogtest between baseline and week 24 Timepoints:week 24 ; Outcome name:The CGI-S scale measures the overall severity of the disease at a given time. It is rated with a 7-point Likert scale that ranges from 1 (normal, not at all sick) to 7 (among the most extremely ill). Measure:Change in CGI score - Severity between baseline and week 24 Timepoints:week 24 ; Outcome name:The CGI-S scale measures the overall severity of the disease at a given time. It is rated with a 7-point Likert scale that ranges from 1 (normal, not at all sick) to 7 (among the most extremely ill). Measure:Proportion of subjects with scores 1,2,3 (showing improvement) in the CGI change scale in week 24 Timepoints:week 24 ; Outcome name:The CGI-S scale measures the overall severity of the disease at a given time. It is rated with a 7-point Likert scale that ranges from 1 (normal, not at all sick) to 7 (among the most extremely ill). Measure:CGI scale score - Change in week 24 Timepoints:week 24 | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Finland, Germany, India, Italy, Mexico, Poland, Portugal, South Africa, Spain, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed