A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS) (Lithium)
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ClinicalTrials.gov Identifier: NCT00790582 |
Recruitment Status :
Completed
First Posted : November 13, 2008
Results First Posted : October 30, 2020
Last Update Posted : October 30, 2020
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Sponsor:
Forbes Norris MDA/ALS Research Center
Collaborator:
Muscular Dystrophy Association
Information provided by (Responsible Party):
Dr. Robert Miller, Forbes Norris MDA/ALS Research Center
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Amyotrophic Lateral Sclerosis |
Intervention |
Drug: lithium carbonate |
Enrollment | 109 |
Participant Flow
Recruitment Details | Patients were enrolled between May 2008 and February 2009. Inclusion criteria were a diagnosis of probable or definite ALS (12), age 21-85 years, forced vital capacity (FVC) greater than or equal to 75% of predicted, and onset of weakness within 3 years. Patients taking riluzole were on a stable dose for at least 30 days. |
Pre-assignment Details |
This was an open label single-arm Phase II screening trail. All enrolled subjects (n=109) were treated. Their results were compared with placebo subjects from an historical database of ALS placebo patients from recent studies (n=249). Thus the number enrolled (n=109) does not equal the total number of subjects (n=358). Enrolled subjects started lithium carbonate at 150 mg twice daily. If subjects did not tolerate a dose it was tapered by 150 mg increments to the maximum tolerated dosage. |
Arm/Group Title | Treatment | Control |
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109 subjects were assigned to treatment with lithium carbonate | 249 placebo subjects from previous clinical trials |
Period Title: Overall Study | ||
Started | 109 | 249 |
Completed | 78 | 162 |
Not Completed | 31 | 87 |
Reason Not Completed | ||
Death | 14 | 32 |
Physician Decision | 7 | 1 |
Lost to Follow-up | 3 | 3 |
Withdrawal by Subject | 7 | 51 |
Baseline Characteristics
Arm/Group Title | Lithium Carbonate | Historical Controls | Total | |
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[Not Specified] | [Not Specified] | Total of all reporting groups | |
Overall Number of Baseline Participants | 109 | 249 | 358 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 109 participants | 249 participants | 358 participants | |
56.2 (11.7) | 57.6 (11.0) | 57.2 (11.2) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 109 participants | 249 participants | 358 participants |
<=18 years | 0 | 0 | 0 | |
Between 18 and 65 years | 84 | 186 | 270 | |
>=65 years | 25 | 63 | 88 | |
18 to 75 years | 109 | 249 | 358 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 109 participants | 249 participants | 358 participants | |
Female |
38 34.9%
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83 33.3%
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121 33.8%
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Male |
71 65.1%
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166 66.7%
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237 66.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 109 participants | 249 participants | 358 participants |
109 | 249 | 358 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Giovanna Kushner |
Organization: | Forbes Norris MDA/ALS Center |
Phone: | 415-600-3983 |
EMail: | kushneg@cpmcri.org |
Responsible Party: | Dr. Robert Miller, Forbes Norris MDA/ALS Research Center |
ClinicalTrials.gov Identifier: | NCT00790582 |
Other Study ID Numbers: |
28.013 |
First Submitted: | November 12, 2008 |
First Posted: | November 13, 2008 |
Results First Submitted: | February 3, 2011 |
Results First Posted: | October 30, 2020 |
Last Update Posted: | October 30, 2020 |