Trial · NCT03589976

A Futility Trial of Sirolimus in Multiple System Atrophy

NCT03589976, Phase 2, Terminated, NYU Langone Health; results first posted 2021-12-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Futility Trial of Sirolimus in Multiple System Atrophy. Trials, record NCT03589976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03589976

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Futility Trial of Sirolimus in Multiple System Atrophy
NCT number: NCT03589976
Status: Terminated
Phases: Phase 2
Enrollment: 47 participants, actual
Lead sponsor: NYU Langone Health
Conditions: Multiple System Atrophy
Interventions: Sirolimus 2 MG, Placebo
First posted: 2018-07-18
Last updated: 2021-12-07
Results first posted: 2021-12-07

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to 48 Weeks in United Multiple System Atrophy Rating Score (UMSARS) Total Score	Baseline, 48 Weeks	UMSARS is a validated, disease-specific scale representing the diverse signs and symptoms in MSA. USMARS has an Activities of Daily Living score (UMSARS-1, 12 questions) that evaluates motor including autonomic activities and the Motor Examination score (UMSARS-2, 14 questions). UMSARS-3 measures supine/standing BP and UMSARS-4 is a disability scale. The total range of score is 1-109; Higher scores on the UMSARS scales mean poorer health.
Secondary	Change From Baseline to 48 Weeks in UMSARS-1	Baseline, 48 Weeks	The Activities of Daily Living score (UMSARS-1, 12 questions) evaluates impact of symptoms, including autonomic, on activities of daily living. 12 functional situations are rated between 0-4. The total range of score is 0-48; the higher the score, the more problems conducting activities of daily living.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to 48 Weeks in United Multiple System Atrophy Rating Score (UMSARS) Total Score	Baseline, 48 Weeks		score on a scale	MEAN
SECONDARY	Change From Baseline to 48 Weeks in UMSARS-1	Baseline, 48 Weeks		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to 48 Weeks in United Multiple System Atrophy Rating Score (UMSARS) Total Score	Sirolimus	13.92	Standard Deviation 8.32	score on a scale
Change From Baseline to 48 Weeks in United Multiple System Atrophy Rating Score (UMSARS) Total Score	Placebo	11.3	Standard Deviation 8	score on a scale
Change From Baseline to 48 Weeks in UMSARS-1	Sirolimus	5.65	Standard Deviation 5.91	score on a scale
Change From Baseline to 48 Weeks in UMSARS-1	Placebo	5.33	Standard Deviation 3.81	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sirolimus	35
Overall Study	STARTED	Placebo	12
Overall Study	COMPLETED	Sirolimus	16
Overall Study	COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Sirolimus	19
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events24

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
other	Infections	Infections and infestations	Sirolimus	21	35
other	Infections	Infections and infestations	Placebo	4	12
other	Aphthae, gingivitis, and oral herpes-like vesicles	Skin and subcutaneous tissue disorders	Sirolimus	15	35
other	Aphthae, gingivitis, and oral herpes-like vesicles	Skin and subcutaneous tissue disorders	Placebo	2	12
other	Diarrhea	Gastrointestinal disorders	Sirolimus	16	35
other	Diarrhea	Gastrointestinal disorders	Placebo	2	12
other	Edema in Lower Limbs	Vascular disorders	Sirolimus	17	35
other	Edema in Lower Limbs	Vascular disorders	Placebo	1	12
other	Acne, Petechiae, Rash	Skin and subcutaneous tissue disorders	Sirolimus	13	35
other	Acne, Petechiae, Rash	Skin and subcutaneous tissue disorders	Placebo	2	12

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sirolimus	5	35
Total, all-cause mortality	Placebo	1	12
Total, other adverse events	Sirolimus	31	35
Total, other adverse events	Placebo	9	12
Total, serious adverse events	Sirolimus	9	35
Total, serious adverse events	Placebo	2	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35040506	DERIVED

Source PubMed

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
Sirolimus vs Placebo: deaths from any cause	Trial comparisons
Sirolimus 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03589976

GET https://conductscience.org/api/trials/v1/NCT03589976/events?page=2

API reference For AI assistants