Trial · NCT00818389
Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
NCT00818389, Phase 2, Phase 3, Terminated, Massachusetts General Hospital; results first posted 2011-04-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS). Trials, record NCT00818389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00818389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
- NCT number
- NCT00818389
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 84 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Lithium Carbonate, Riluzole, placebo
- First posted
- 2009-01-07
- Last updated
- 2011-04-19
- Results first posted
- 2011-04-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R) | 9 months: Baseline to study termination (January 2009 - October 2009) | ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 \& 52, dependent on enrollment duration. Number of subjects who failed by treatment group was evaluated. Failure was defined as 6-point drop in ALSFRS-R or death from baseline. |
| Secondary | Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R) | 9 months: Baseline to study termination (January 2009 - October 2009) | ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 \& 52, dependent on enrollment duration. Secondary efficacy was evaluated by comparing the mean rate of decline of ALSFRS-R score by treatment group. |
| Secondary | Vital Capacity (VC) (Percent of Predicted Normal) | 9 months: Baseline to study termination (January 2009- October 2009) | Secondary efficacy was measured by comparing the rate of decline of mean VC by treatment group. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R) | 9 months: Baseline to study termination (January 2009 - October 2009) | Scores on a scale | MEAN | |
| PRIMARY | Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R) | 9 months: Baseline to study termination (January 2009 - October 2009) | Participants | NUMBER | |
| SECONDARY | Vital Capacity (VC) (Percent of Predicted Normal) | 9 months: Baseline to study termination (January 2009- October 2009) | Percent of predicted normal | MEAN |
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 |
|---|---|---|---|---|---|
| Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R) | Lithium + Riluzole | -1.24 | Standard Error 0.21 | Scores on a scale | |
| Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R) | Placebo + Riluzole | -1.09 | Standard Error 0.20 | Scores on a scale | |
| Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R) | Lithium + Riluzole | 18 | Participants | ||
| Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R) | Placebo + Riluzole | 14 | Participants | ||
| Vital Capacity (VC) (Percent of Predicted Normal) | Lithium + Riluzole | -1.89 | Standard Error 0.45 | Percent of predicted normal | |
| Vital Capacity (VC) (Percent of Predicted Normal) | Placebo + Riluzole | -3.12 | Standard Error 0.47 | Percent of predicted normal |
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 + Riluzole | 40 | |
| Overall Study | STARTED | Placebo + Riluzole | 44 | |
| Overall Study | COMPLETED | Lithium + Riluzole | 36 | |
| Overall Study | COMPLETED | Placebo + Riluzole | 38 | |
| Overall Study | NOT COMPLETED | Lithium + Riluzole | 4 | |
| Overall Study | NOT COMPLETED | Placebo + Riluzole | 6 |
Source ClinicalTrials.gov
Adverse events122
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 | Anorexia | Gastrointestinal disorders | Lithium + Riluzole | 6 | 40 | 7 |
| other | Anorexia | Gastrointestinal disorders | Placebo + Riluzole | 2 | 44 | 4 |
| other | Bruising (in absence of grade 3 or 4 thrombocytopenia) | Blood and lymphatic system disorders | Lithium + Riluzole | 5 | 40 | 7 |
| other | Bruising (in absence of grade 3 or 4 thrombocytopenia) | Blood and lymphatic system disorders | Placebo + Riluzole | 1 | 44 | 2 |
| other | Chest congestion | Respiratory, thoracic and mediastinal disorders | Lithium + Riluzole | 6 | 40 | 8 |
| other | Chest congestion | Respiratory, thoracic and mediastinal disorders | Placebo + Riluzole | 5 | 44 | 5 |
| other | Constipation | Gastrointestinal disorders | Lithium + Riluzole | 5 | 40 | 7 |
| other | Constipation | Gastrointestinal disorders | Placebo + Riluzole | 8 | 44 | 9 |
| other | Depression | Psychiatric disorders | Lithium + Riluzole | 6 | 40 | 9 |
| other | Depression | Psychiatric disorders | Placebo + Riluzole | 4 | 44 | 6 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lithium + Riluzole | ||
| Total, all-cause mortality | Placebo + Riluzole | ||
| Total, other adverse events | Lithium + Riluzole | 39 | 40 |
| Total, other adverse events | Placebo + Riluzole | 43 | 44 |
| Total, serious adverse events | Lithium + Riluzole | 10 | 40 |
| Total, serious adverse events | Placebo + Riluzole | 8 | 44 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01NS049640 | Clinical Trial of Ceftriaxone in Subjects with ALS | CUDKOWICZ, MERIT E | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2006 to 2012 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lithium + Riluzole vs Placebo + Riluzole: Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R) | Trial comparisons |
| Lithium + Riluzole vs Placebo + Riluzole: 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/NCT00818389
GET https://conductscience.org/api/trials/v1/NCT00818389/events?page=2