Trial · NCT00997672

Lithium in Multiple System Atrophy

NCT00997672, Phase 2, Terminated, Federico II University; results first posted 2014-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lithium in Multiple System Atrophy. Trials, record NCT00997672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00997672

On this page

Trial

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

Title: Lithium in Multiple System Atrophy
NCT number: NCT00997672
Status: Terminated
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: Federico II University
Conditions: Multiple System Atrophy
Interventions: Lithium Carbonate, Placebo
First posted: 2009-10-19
Last updated: 2014-02-03
Other registries' IDs: eudract:2009-016377-15
Results first posted: 2014-02-03
Limitations and caveats: Limitation of the study is small sample size of nine randomized patients. This may have determined uneven distribution of AEs due to random variation. Taking into account these limitations, we do not encourage future studies with lithium in MSA.

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Primary Endpoint of the Study Will be the Difference in Number and Relative Frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) Recorded During the Study, Between Treatment and Placebo Group.	the endpoint will be recorded at all visits	Number of Adverse Events and their relative frequency in treatment groups was analyzed
Secondary	Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.	0 weeks
Secondary	Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.	0 weeks
Secondary	The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.	0 weeks
Secondary	Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.	0 weeks
Secondary	Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.	24 weeks
Secondary	Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.	48 weeks
Secondary	Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.	48 weeks
Secondary	The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.	24 weeks
Secondary	The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.	48 weeks

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Primary Endpoint of the Study Will be the Difference in Number and Relative Frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) Recorded During the Study, Between Treatment and Placebo Group.	the endpoint will be recorded at all visits	number of AEs	NUMBER
SECONDARY	Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.	0 weeks
SECONDARY	Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.	0 weeks
SECONDARY	The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.	0 weeks
SECONDARY	Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.	0 weeks
SECONDARY	Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.	24 weeks
SECONDARY	Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.	48 weeks
SECONDARY	Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.	48 weeks
SECONDARY	The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.	24 weeks
SECONDARY	The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.	48 weeks

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Primary Endpoint of the Study Will be the Difference in Number and Relative Frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) Recorded During the Study, Between Treatment and Placebo Group.	Lithium CARBONATE 150 or 300 mg		58		number of AEs
Primary Endpoint of the Study Will be the Difference in Number and Relative Frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) Recorded During the Study, Between Treatment and Placebo Group.	Placebo		21		number of AEs

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lithium CARBONATE 150 or 300 mg	4
Overall Study	STARTED	Placebo	5
Overall Study	COMPLETED	Lithium CARBONATE 150 or 300 mg	0
Overall Study	COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Lithium CARBONATE 150 or 300 mg	4
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events26

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	Lower limbs weakness	Nervous system disorders	Lithium CARBONATE 150 or 300 mg	3	4	4
other	Lower limbs weakness	Nervous system disorders	Placebo	3	5	5
other	sleepiness	Nervous system disorders	Lithium CARBONATE 150 or 300 mg	1	4	4
other	sleepiness	Nervous system disorders	Placebo	2	5	5
other	Incontinence	Renal and urinary disorders	Lithium CARBONATE 150 or 300 mg	1	4	4
other	Incontinence	Renal and urinary disorders	Placebo	3	5	5
other	Cystitis	Renal and urinary disorders	Lithium CARBONATE 150 or 300 mg	2	4	4
other	Cystitis	Renal and urinary disorders	Placebo	1	5	5
other	diarrhea	Gastrointestinal disorders	Lithium CARBONATE 150 or 300 mg	2	4	4
other	diarrhea	Gastrointestinal disorders	Placebo	2	5	5

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lithium CARBONATE 150 or 300 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Lithium CARBONATE 150 or 300 mg	4	4
Total, other adverse events	Placebo	3	5
Total, serious adverse events	Lithium CARBONATE 150 or 300 mg	4	4
Total, serious adverse events	Placebo	1	5

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
18725592	BACKGROUND

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Lithium CARBONATE 150 or 300 mg vs Placebo: serious adverse events

Source 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/NCT00997672

GET https://conductscience.org/api/trials/v1/NCT00997672/events?page=2

API reference For AI assistants