Trial · NCT00790582

A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)

NCT00790582, Phase 2, Completed, Forbes Norris MDA/ALS Research Center; results first posted 2020-10-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS). Trials, record NCT00790582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00790582

On this page

Trial

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

Title: A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
NCT number: NCT00790582
Status: Completed
Phases: Phase 2
Enrollment: 109 participants, actual
Lead sponsor: Forbes Norris MDA/ALS Research Center
Conditions: Amyotrophic Lateral Sclerosis
Interventions: lithium carbonate
First posted: 2008-11-13
Last updated: 2020-10-30
Results first posted: 2020-10-30

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change in Monthly Rate of Decline in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score - Revised)	Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13	This questionnaire has 12 questions about the patient's ability to complete certain daily activities. There are three questions each about the mouth area, arms, legs, and breathing. A normal score is 48 with each question scored at 0 (worst) to 4 (normal function). In research studies, the change in slope is measured in number of points changed per month. Maximum possible=48 (normal) Minimum=0 (severe dysfunction)
Secondary	Vital Capacity	Screen, Baseline, Month 1,3,6,9,12	Vital Capacity (VC) is a breathing test in which the patient is asked to take a deep breath and then blow out all of the breath through a tube. The volume is measured in number of liters. It is converted to a percent predicted for the patient's age, height, and gender.

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 in Monthly Rate of Decline in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score - Revised)	Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13		points per month	MEAN
SECONDARY	Vital Capacity	Screen, Baseline, Month 1,3,6,9,12		Decline in the percent predicted/month	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 in Monthly Rate of Decline in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score - Revised)	Lithium Carbonate	1.20	95% Confidence Interval 1.04 to 1.35	points per month
Change in Monthly Rate of Decline in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score - Revised)	Historical Controls	1.01	95% Confidence Interval 0.90 to 1.11	points per month
Vital Capacity	Lithium Carbonate	2.84	95% Confidence Interval 2.36 to 3.32	Decline in the percent predicted/month
Vital Capacity	Control	2.91	95% Confidence Interval 2.59 to 3.23	Decline in the percent predicted/month

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment	109
Overall Study	STARTED	Control	249
Overall Study	COMPLETED	Treatment	78
Overall Study	COMPLETED	Control	162
Overall Study	NOT COMPLETED	Treatment	31
Overall Study	NOT COMPLETED	Control	87

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	Gastrointestinal	Gastrointestinal disorders	Lithium Carbonate	16	109
other	Gastrointestinal	Gastrointestinal disorders	Historical Controls	138	249	406
other	Cardiovascular	Cardiac disorders	Lithium Carbonate	1	109
other	Cardiovascular	Cardiac disorders	Historical Controls	46	249	63
other	Dermatological	Skin and subcutaneous tissue disorders	Lithium Carbonate	5	109
other	Dermatological	Skin and subcutaneous tissue disorders	Historical Controls	99	249	211
other	Ears, Nose, Throat	Ear and labyrinth disorders	Lithium Carbonate	6	109
other	Ears, Nose, Throat	Ear and labyrinth disorders	Historical Controls	86	249	151
other	Endocrine/Metabolic	Endocrine disorders	Lithium Carbonate	4	109
other	Endocrine/Metabolic	Endocrine disorders	Historical Controls	8	249	8

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lithium Carbonate	14	109
Total, all-cause mortality	Historical Controls	44	249
Total, other adverse events	Lithium Carbonate	99	109
Total, other adverse events	Historical Controls	175	249
Total, serious adverse events	Lithium Carbonate	62	109
Total, serious adverse events	Historical Controls	91	249

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
18250315	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 comparisons2

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

Comparison	Source
Lithium Carbonate vs Historical Controls: deaths from any cause	Trial comparisons
Lithium Carbonate vs Historical Controls: 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/NCT00790582

GET https://conductscience.org/api/trials/v1/NCT00790582/events?page=2

API reference For AI assistants