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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00790582
• Date of registration: 12/11/2008
• Prospective Registration: No
• Primary sponsor: Forbes Norris MDA/ALS Research Center
• Public title: A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS) Lithium
• Scientific title: A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: May 2008
• Target sample size: 109
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00790582
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Robert G Miller, MD
• Affiliation: California Pacific Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of laboratory-supported probable, probable, or definite ALS

- Vital capacity of at least 75% of predicted

- Onset of weakness within 3 years prior to enrollment

- If patients are on riluzole, they must be on a stable dose for at least 30 days prior
to baseline visit

- Women of childbearing potential must be surgically sterile or using an effective
method of birth control and have a negative pregnancy test

- Willing and able to give informed consent

Exclusion Criteria:

- Diagnosis of other neurodegenerative disease

- Need tracheotomy ventilation or non-invasive ventilation 23 or more hours/day

- Clinically significant history of any unstable medical condition in past 30 days

- History of renal

- History of liver disease

- Current pregnancy or lactation

- Use of lithium within thirty days of enrollment

- Significantly limited mental capacity

- History of recent drug or alcohol abuse

- Use of any investigational drug within 30 days prior to enrollment



Age minimum: 21 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: lithium carbonate

Primary Outcome(s)

Change in Monthly Rate of Decline in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score - Revised) [Time Frame: Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13]

Secondary Outcome(s)

Vital Capacity [Time Frame: Screen, Baseline, Month 1,3,6,9,12]

Secondary ID(s)

28.013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Muscular Dystrophy Association

Results

• Results available: Yes
• Date Posted: 30/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00790582