None listed
Conditions
Interventions
Group 1 Type of group
Safinamide, MAO-B inhibitor 50 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
Group name:Group 3 Type of group
matching placebo tablets, orally once a day
Sponsors
NEWRON PHARMACEUTICALS SpA.,
Eligibility
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: • The subject completed the 24 weeks of Trial 27918, • The subject successfully completed all the requirements for the trial in Trial 27918. • If you are female, you must be post-menopausal for at least 2 years, have been surgically sterilized or have had a hysterectomy or, if you are of childbearing age, you must be willing to avoid pregnancy using a suitable contraceptive method as defined in section 6.4.9. for four weeks before the last dose of the trial medication, during the trial and four weeks after the last dose of the trial medication. For the purposes of this trial, women of childbearing age are defined as; All female subjects after puberty, unless they have spent at least two years in a post-menopausal state, have been surgically sterilized or are sexually inactive. • The subject has the will and ability to participate in the essay and has provided written informed consent.
Exclusion criteria
Exclusion criteria: • In the case of being female, if you are pregnant or breastfeeding. • The subject experienced a clinically significant adverse effect during Trial 27918. • The subject has shown a clinically significant deterioration during his participation in Trial 27918, which could put the subject at risk according to the opinion of the researcher. • Motor impairment during trial 27918 that required an upward adjustment of existing antiparkinsonian medication or the initiation of additional antiparkinsonian medication. • The researcher considers that participating in trial 27938 is not the best for the subject. • Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer or suffer from these signs or symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Change in the dose of the agonist DA; aggregate of another DA agonist, levodopa, or other therapy for PD; or discontinuation due to lack of efficiency Measure:The time from the beginning to the first intervention Timepoints:Week 78 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:UPDRS is a classification tool that is used to follow the longitudinal course of Parkinsons disease. It is made up of four sections that evaluate the following: Section I - Mental state, behavior and humor; Section II - Activities of daily living; Section III - Motor test; and Section IV - Complications of therapy. Measure:Change in the score of Section III of the UPDRS (motor) Timepoints:Week 78 ; Outcome name:The CGI-C scale measures the change in the clinical status of the subject from a specific point in time using a scale of 7 points, ranging from 1 (much better) to 7 (much worse), with a score of 4 indicating There were no changes. Measure:Score of the CGI-Change scale, modification from Day O of Trial 27918 until Week 78. Timepoints:Week 78. ; Outcome name:The EQ-5D is a standardized instrument to use as a measure of health outcomes. It provides a simple descriptive profile and a unique index value for health status and has been used in various diseases. Measure:Change in the EQ-5D score from the beginning until Week 78. Timepoints:Week 78. | — |
Contacts
Public ContactGABRIELA LOYOLA
IQVIA RDS Peru S.R.L
Outcome results
None listed