Idiopathic Parkinson's Disease MedDRA version: 14.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Safinamide
Product Code: NW-1015
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Product Name: Safi
Sponsors
Newron Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion into this trial, the subjects must fulfill all of the following criteria: 1. The subject completed 24 weeks of Trial 27918. 2. The subject successfully completed all trial requirements in Trial 27918. 3. If female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in section 6.4.9 of the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as: “All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive”. 4. Subject is willing and able to participate in the trial and has provided written, informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible for inclusion in this trial the subjects must not meet any of the following criteria: 1. If female, the subject is pregnant or lactating. 2. The subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator’s opionion. 3. The subject has shown clinically significant deterioration during participation in Trial 27918. 4. Motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication. 5. The investigator deems it is not in the subject’s best interest to participate to trial 27938 6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the time to first intervention of two doses of safinamide (50 and 100 mg/day) compared to placebo as add-on therapy to a single dopamine agonist.;Secondary Objective: The secondary objectives are to evaluate the changes from baseline to W78 in motor function, activities of daily living, global clinical status, health related quality of life and cognition with safinamide (50 and 100 mg/day) compared to placebo as add-on therapy to a single dopamine agonist. The tertiary objectives are to evaluate the changes from baseline to W78 in depression, staging of disease, motor complications, cognition and Health Resource Utilization.;Primary end point(s): Time from baseline to first intervention, (change in the dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacy).;Timepoint(s) of evaluation of this end point: first intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects requiring intervention • UPDRS Section III (motor) score change from baseline to W78 • UPDRS Section II (ADL) score change from baseline to W78 • CGI – Change scale score, change from Day 0 of Trial 27918 to W78 • CGI – Severity scale score change from baseline to W78 • EQ-5D score change from baseline to W78 • PDQ-39 score change from baseline to W78 • Cogtest® PD battery test score change from baseline to W78;Timepoint(s) of evaluation of this end point: Week 78 | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Finland, Germany, India, Italy, Mexico, Peru, Poland, Portugal, Slovakia, South Africa, Spain, United States
Contacts
Public ContactChief Medical Officer
Newron Pharmaceuticals SpA
Outcome results
None listed