Trial · NCT01259388
A Pilot Study of Lithium in Progressive Multiple Sclerosis
NCT01259388, Phase 1, Phase 2, Completed, VA Office of Research and Development; results first posted 2019-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study of Lithium in Progressive Multiple Sclerosis. Trials, record NCT01259388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01259388
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of Lithium in Progressive Multiple Sclerosis
- NCT number
- NCT01259388
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Multiple Sclerosis
- Interventions
- Lithium Carbonate
- First posted
- 2010-12-14
- Last updated
- 2019-09-10
- Results first posted
- 2019-09-10
- Limitations and caveats
This was a pilot study and thus by design was not powered to detect therapeutic differences. The primary purpose of the study was feasibility with the specified outcomes intended to generate preliminary data for subsequent research.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Change in Brain Parenchymal Fraction | 2 years | Paired comparison of change in brain parenchymal fraction during Lithium treatment and during observation period |
| Secondary | Total Relapses | 2 years | Total number of relapses which occurred during the Li-treatment and observation study phases. |
| Secondary | Change in Expanded Disability Status Scale Score | 2 years | The Expanded Disability Status Scale (EDSS) is an ordinal scale ranging from 0 to 10 used to assess disability in multiple sclerosis (MS). A score of 0 denotes no neurological impairments and no neurological exam abnormalities, while a score of 10 denotes death due to MS. The EDSS is derived from subscales called Functional System Scales at the lower range of the EDSS, and from ambulatory impairments and overall functional impairment at higher ranges of the scale. The Functional System scores (Vision, Brainstem, Pyramidal, Sensory, Cerebellar, Cognitive, Bladder and Bowel) are used to generate the EDSS based on pre-specified rules that determine the overall EDSS score. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Change in Brain Parenchymal Fraction | 2 years | Due to this being a crossover study design, each participant's data was evaluated for each phase of the trial (Li treatment and observation). Only subjects who completed both years (and thus both phases) of the study were included. | percentage of change in brain volume | MEAN |
| SECONDARY | Total Relapses | 2 years | Due to this being a crossover study design, each participant's data was evaluated for each phase of the trial (Li treatment and observation). Only subjects who completed both years (and thus both phases) of the study were included. | relapses | NUMBER |
| SECONDARY | Change in Expanded Disability Status Scale Score | 2 years | Due to this being a crossover study design, each participant's data was evaluated for each phase of the trial (Li treatment and observation). Only subjects who completed both years (and thus both phases) of the study were included. | Units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Change in Brain Parenchymal Fraction | Lithium | 0.107 | Standard Error 0.38 | percentage of change in brain volume | |
| Rate of Change in Brain Parenchymal Fraction | Observation | -0.355 | Standard Error 0.22 | percentage of change in brain volume | |
| Total Relapses | Lithium | 2 | relapses | ||
| Total Relapses | Observation | 5 | relapses | ||
| Change in Expanded Disability Status Scale Score | Lithium | 0 | Inter-Quartile Range 0 to 0 | Units on a scale | |
| Change in Expanded Disability Status Scale Score | Observation | 0.5 | Inter-Quartile Range 0 to 1 | Units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lithium First (One Year), Then Observation (One Year) | 11 | |
| Overall Study | STARTED | Observation First (One Year), Then Lithium (One Year) | 12 | |
| Overall Study | COMPLETED | Lithium First (One Year), Then Observation (One Year) | 6 | |
| Overall Study | COMPLETED | Observation First (One Year), Then Lithium (One Year) | 11 | |
| Overall Study | NOT COMPLETED | Lithium First (One Year), Then Observation (One Year) | 5 | |
| Overall Study | NOT COMPLETED | Observation First (One Year), Then Lithium (One Year) | 1 |
Source ClinicalTrials.gov
Adverse events30
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 | Excess thirst | General disorders | Lithium | 18 | 23 | 112 |
| other | Excess thirst | General disorders | Observation | 0 | 18 | |
| other | Fatigue | General disorders | Lithium | 15 | 23 | |
| other | Fatigue | General disorders | Observation | 0 | 18 | |
| other | Polyuria | Renal and urinary disorders | Lithium | 15 | 23 | |
| other | Polyuria | Renal and urinary disorders | Observation | 0 | 18 | |
| other | Weight gain | General disorders | Lithium | 13 | 23 | |
| other | Weight gain | General disorders | Observation | 0 | 18 | |
| other | Weight loss | General disorders | Lithium | 10 | 23 | |
| other | Weight loss | General disorders | Observation | 0 | 18 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lithium | ||
| Total, all-cause mortality | Observation | ||
| Total, other adverse events | Lithium | 22 | 23 |
| Total, other adverse events | Observation | 0 | 18 |
| Total, serious adverse events | Lithium | 1 | 23 |
| Total, serious adverse events | Observation | 1 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32760832 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lithium vs Observation: 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.
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/NCT01259388
GET https://conductscience.org/api/trials/v1/NCT01259388/events?page=2