PARKINSON’S DISEASE WITH MOTOR FLUCTUATIONS
Conditions
Brief summary
We could hypothesize a mean change of NRS difference between the experimental (safinamide) and the control group (placebo) of 1.6 points on NRS in favor of the experimental group after 12 weeks of treatment
Detailed description
We hypothesize that the safinamide group will demonstrate a greater mean improvement compared to the placebo group across several secondary outcome measures. The expected between-group difference for UPDRS Part III and PDQ-39 is estimated to range from –0.9 to –2.3 points and –16.5 to – 18.6 points, respectively. For KPPS, BPI (intensity and interference), and UPDRS Part IV it is not possible to estimate a between-group difference.
Interventions
DRUGSafinamide 100 mg PLACEBO:
Safinamide 100 mg PLACEBO film-coated tablets have the same composition as the relevant Investigational Medicinal Products except for the presence of Active Substance that is missing in the placebo formulations. The missing amount of active substance Safinamide methanesulfonate is replaced in the PLACEBO formulation with the same amount of Microcrystalline cellulose
DRUGone of the excipients already present in the authorised formulation
DRUGXadago 100 mg film-coated tablets
DRUGXadago 50 mg film-coated tablets
DRUGSafinamide 50 mg PLACEBO:
Safinamide 50 mg
DRUGPLACEBO film-coated tablets have the same composition as the relevant
Investigational Medicinal Products except for the presence of Active Substance that is missing in the
placebo formulations. The missing amount of active substance Safinamide methanesulfonate is
replaced in the PLACEBO formulation with the same amount of Microcrystalline cellulose
DRUGone of the
excipients already present in the authorised formulation.
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We could hypothesize a mean change of NRS difference between the experimental (safinamide) and the control group (placebo) of 1.6 points on NRS in favor of the experimental group after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| We hypothesize that the safinamide group will demonstrate a greater mean improvement compared to the placebo group across several secondary outcome measures. The expected between-group difference for UPDRS Part III and PDQ-39 is estimated to range from –0.9 to –2.3 points and –16.5 to – 18.6 points, respectively. For KPPS, BPI (intensity and interference), and UPDRS Part IV it is not possible to estimate a between-group difference. | — |
Countries
Italy
Outcome results
None listed