None listed
Conditions
Interventions
Intervention1: Safinamide: Safinamide 50 mg at Weeks 12, 24, 36, 48, 60 and 78
Control Intervention1: Safinamide: safinamide 100 mg Weeks 12, 24, 36, 48, 60 and 78
Control Intervention2: Placebo: Week
Sponsors
In USA :EMD Serono, Inc One Technology Place, Rockland MA 02370
Other countries:
Merck Serono S.A. - Geneva 9 Chemin des Mines
1202 Geneva Switzerland
Eligibility
Inclusion criteria
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 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
Exclusion criteria
Exclusion 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 opinion. 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 antiparkinsonian 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 |
|---|---|
| Change in the dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacyTimepoint: Time from baseline to first intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 W78EQ-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: From baseline to Week 78 | — |
Countries
India
Contacts
Public ContactDr. Khokan Debnath
Merck Limited
Outcome results
None listed