Conditions: Multiple System Atrophy
Keywords: MSA, safinamide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 49
Healthy volunteers: no

Brief summary:
The study is a placebo controlled study, with two parallel arms, in which participants will be randomly assigned in a 2:1 ratio to receive either active (200 mg safinamide) or placebo in a double blind manner. Study population is patients diagnosed, with possible or probable parkinsonian variant of Multiple System Atrophy who are on a stable treatment of levodopa

Detailed description:
The overall design is a parallel group, placebo controlled, double blind study. The target population are participants diagnosed with possible or probable parkinsonian variant of Multiple System Atrophy who are on stable doses of levodopa.

Trial participation will be up to a maximum duration of 14 weeks and will comprise a screening period (up to 2 weeks), a 2-week run in period during which subjects will receive 1 tablet (either 100 mg safinamide or matching placebo), followed by a 10-week period, during which study participants will take 2 tablets of study medication (200 mg safinamide or placebo) once daily, taken in the morning in addition to their morning levodopa dose. A telephone follow-up call will be performed 2 weeks after the end of treatment.

Arms:
arm 1: Safinamide methanesulfonate film-coated tablets once daily arm 2: Safinamide Methanesulfonate matching placebo film-coated tablets once daily

Interventions: intervention 1: Safinamide Methanesulfonate intervention 2: Safinamide Methanesulfonate matching placebo
Intervention descriptions: intervention 1: 100 mg (free base) intervention 2: 100 mg placebo

Protocol document:
Prot_000.pdf: 
 
 
 
16. 
APPENDICES 
APPENDIX 16.1: 
STUDY INFORMATION 
APPENDIX 16.1.1: PROTOCOL AND PROTOCOL AMENDMENTS 
Summary of Changes for Protocol Amendment 01, 13 July 2020 ................................................. 2 
Protocol Amendment 01, Version 2.0, 13 July 2020 .................................................................... 10 
Protocol Administrative Letter #1, 09 August 2019 ..................................................................... 71 
Original Protocol, Version 1.0, 21 February 2019 ........................................................................ 75 
 































































































































































































































































SAP_001.pdf: 
APPENDIX 16.1.9: DOCUMENTATION OF STATISTICAL METHODS 
Statistical Analysis Plan, Version 2.0, 20 January 2021 ................................................................. 2 
Statistical Analysis Plan, Version 1.0, 13 November 2020 .......................................................... 22