Trial · NCT03753763
Safinamide for Multiple System Atrophy (MSA)
NCT03753763, Phase 2, Completed, Zambon SpA; results first posted 2021-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safinamide for Multiple System Atrophy (MSA). Trials, record NCT03753763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03753763
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safinamide for Multiple System Atrophy (MSA)
- NCT number
- NCT03753763
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Zambon SpA
- Conditions
- Multiple System Atrophy
- Interventions
- Safinamide Methanesulfonate, Safinamide Methanesulfonate matching placebo
- First posted
- 2018-11-27
- Last updated
- 2021-10-13
- Other registries' IDs
- eudract:2018-004145-16
- Results first posted
- 2021-08-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Throughout the study, from baseline (and at each interim visit) to telephone follow-up visit at 14 week. | While evaluating safety and tolerability of safinamide, 200 mg od, compared with placebo, severity of TEAEs, their relationship to study drug, their seriousness and their consequences were assessed. TEAEs were defined as adverse events (AEs) that started after the first dose of study drug. |
| Secondary | Change From Baseline to Week 12 in the Goniometric Measurement for Anterior Displacement | From baseline to week 12 | To evaluate the potential efficacy of safinamide 200 mg od, as add-on therapy, on quality of life (change in anterior displacement). The goniometric measurement consists in the posture evaluation of the patient, measuring through a goniometer the angle of the flexion of the trunk. Goniometric measurement of "anterior" displacement was determined using a wall goniometer and expressing the value in degrees in the range of 0 to 90. |
| Secondary | Change From Baseline to Week 12 in the Goniometric Measurement for Lateral Displacement | From baseline to week 12 | To evaluate the potential efficacy of safinamide 200 mg od, as add-on therapy, on quality of life (change in anterior displacement). The goniometric measurement consists in the posture evaluation of the patient, measuring through a goniometer the angle of the flexion of the trunk. Goniometric measurement of "lateral" displacement was determined using a wall goniometer and expressing the value in degrees in the range of 0 to 90. |
| Secondary | Change From Baseline to Week 12 in Unified Multiple System Atrophy Rating Scale (UMSARS), Part II (ITT Population) | From baseline to week 12 | UMSARS is a validated, disease-specific scale representing the diverse signs and symptoms in MSA. Higher scores on the UMSARS scales mean poorer health. UMSARS has the following domains: Part I - Activities of Daily Living score (12 questions ranged in 0-4 \[total score 0-48\]) that evaluates motor including autonomic activities Part II - Motor Examination score (14 questions, \[total score 0-56\]) Part III - Autonomic Examination Part IV - Global disability scale ((1=completely independent; 2=not completely independent; 3=more dependent; 4=very dependent; 5=total dependent and helpless). Only UMSARS Part II total score is reported, which was obtained as the sum of the 14 items in the scale. If any of the items were missing, then the total score was considered missing. Higher scores indicate worse functional situation. |
| Secondary | Change From Baseline to Week 12 in Unified Multiple System Atrophy Rating Scale (UMSARS), Part II (PP Population) | From baseline to week 12 | UMSARS is a validated, disease-specific scale representing the diverse signs and symptoms in MSA. Higher scores on the UMSARS scales mean poorer health. UMSARS has the following domains: Part I - Activities of Daily Living score (12 questions ranged in 0-4 \[total score 0-48\]) that evaluates motor including autonomic activities Part II - Motor Examination score (14 questions, \[total score 0-56\]) Part III - Autonomic Examination Part IV - Global disability scale ((1=completely independent; 2=not completely independent; 3=more dependent; 4=very dependent; 5=total dependent and helpless). Only UMSARS Part II total score is reported, which was obtained as the sum of the 14 items in the scale. If any of the items were missing, then the total score was considered missing. Higher scores indicate worse functional situation. |
| Secondary | Change From Baseline to Week 12 in Multiple System Atrophy Health-Related Quality of Life (MSA-QoL) Scale | From baseline to week 12 | The MSA-QoL is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 to 160, with 0= 'no problem' and 160= "extreme problem". |
| Secondary | Change From Baseline to Week 12 in Montreal Cognitive Assessment (MoCA) Scale | From baseline to week 12 | The Montreal Cognitive Assessment (MoCA) was designed as a tool for rapid screening for mild cognitive impairment. It evaluates different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructive skills, abstraction, calculation and orientation. The administration time of the MoCa is 10 minutes. The MoCA scale ranges from 0 to 30, with higher scores indicating better cognitive functioning. |
| Secondary | Change From Baseline to Week 12 in Unified Dystonia Rating Scale (UDRS) | From baseline to week 12 | UDRS consists of a Historical Section, divided into questionnaires about 1) on-dyskinesia and 2) off -dystonia, and an Objective Section, divided into 3) impairment and 4) disability scales. The Historical Section is scored from 0-60, and the Objective section is scored 0-44, where higher scores reflect greater difficulty or impairment. The Unified Dystonia Rating Scale (UDRS) assesses the motor severity and duration of dystonia in 14 body areas. The total score, obtained as the sum of the severity and duration factors, ranges from 0 to 112. Higher scores indicate worse dystonia. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Throughout the study, from baseline (and at each interim visit) to telephone follow-up visit at 14 week. | The Safety Population included all randomized participants who took at least 1 dose of study drug. This population was used to summarize all safety data. | events | NUMBER |
| SECONDARY | Change From Baseline to Week 12 in the Goniometric Measurement for Anterior Displacement | From baseline to week 12 | The ITT Population included all randomized participants. This population was used for all efficacy variables. | degrees | MEAN |
| SECONDARY | Change From Baseline to Week 12 in the Goniometric Measurement for Lateral Displacement | From baseline to week 12 | The ITT Population included all randomized participants. This population was used for all efficacy variables. | degrees | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Unified Multiple System Atrophy Rating Scale (UMSARS), Part II (ITT Population) | From baseline to week 12 | The ITT Population included all randomized participants. This population was used for all efficacy variables. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Unified Multiple System Atrophy Rating Scale (UMSARS), Part II (PP Population) | From baseline to week 12 | The Per Protocol Population will include all randomized participants who do not have any entry criteria violations or protocol deviations that could significantly impact the assessment or interpretation of efficacy data. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Multiple System Atrophy Health-Related Quality of Life (MSA-QoL) Scale | From baseline to week 12 | The ITT Population included all randomized participants. This population was used for all efficacy variables | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Montreal Cognitive Assessment (MoCA) Scale | From baseline to week 12 | The ITT Population included all randomized participants. This population was used for all efficacy variables. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Unified Dystonia Rating Scale (UDRS) | From baseline to week 12 | The ITT Population included all randomized participants. This population was used for all efficacy variables. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Safinamide | Any TEAEs | 52 | events | |
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Placebo | Any TEAEs | 28 | events | |
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Safinamide | Mild TEAEs | 49 | events | |
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Placebo | Mild TEAEs | 21 | events | |
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Safinamide | Moderate TEAEs | 4 | events | |
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Placebo | Moderate TEAEs | 5 | events | |
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Safinamide | Severe TEAEs | 3 | events | |
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Placebo | Severe TEAEs | 4 | events | |
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Safinamide | Serious TEAEs | 2 | events | |
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | Placebo | Serious TEAEs | 0 | events |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Safinamide | 32 | |
| Overall Study | STARTED | Placebo | 17 | |
| Overall Study | COMPLETED | Safinamide | 26 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Safinamide | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthenia | General disorders | Safinamide | 1 | 32 | 1 |
| other | Asthenia | General disorders | Placebo | 1 | 17 | 1 |
| other | Oedema peripheral | General disorders | Safinamide | 2 | 32 | 2 |
| other | Oedema peripheral | General disorders | Placebo | 0 | 17 | 0 |
| other | Pyrexia | General disorders | Safinamide | 2 | 32 | 2 |
| other | Pyrexia | General disorders | Placebo | 0 | 17 | 0 |
| other | Gait disturbance | General disorders | Safinamide | 0 | 32 | 0 |
| other | Gait disturbance | General disorders | Placebo | 1 | 17 | 1 |
| other | Influenza like illness | General disorders | Safinamide | 1 | 32 | 1 |
| other | Influenza like illness | General disorders | Placebo | 0 | 17 | 0 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safinamide | 1 | 32 |
| Total, all-cause mortality | Placebo | 0 | 17 |
| Total, other adverse events | Safinamide | 21 | 32 |
| Total, other adverse events | Placebo | 11 | 17 |
| Total, serious adverse events | Safinamide | 2 | 32 |
| Total, serious adverse events | Placebo | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Safinamide vs Placebo: deaths from any cause | Trial comparisons |
| Safinamide vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03753763
GET https://conductscience.org/api/trials/v1/NCT03753763/results?page=2