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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
Sponsor:
Collaborator:
Muscular Dystrophy Association
Information provided by (Responsible Party):
Dr. Robert Miller, Forbes Norris MDA/ALS Research Center

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Lithium Carbonate Historical Controls Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 109 249 358
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 109 participants 249 participants 358 participants
Female
38
  34.9%
83
  33.3%
121
  33.8%
Male
71
  65.1%
166
  66.7%
237
  66.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 109 participants 249 participants 358 participants
109 249 358
1.Primary Outcome
Title Change in Monthly Rate of Decline in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score - Revised)
Hide Description 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)
Time Frame Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lithium Carbonate Historical Controls
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 109 249
Mean (95% Confidence Interval)
Unit of Measure: points per month
1.20
(1.04 to 1.35)
1.01
(0.90 to 1.11)
2.Secondary Outcome
Title Vital Capacity
Hide Description 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.
Time Frame Screen, Baseline, Month 1,3,6,9,12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lithium Carbonate Control
Hide Arm/Group Description:
Treatment arm
Placebo arm
Overall Number of Participants Analyzed 109 249
Mean (95% Confidence Interval)
Unit of Measure: Decline in the percent predicted/month
2.84
(2.36 to 3.32)
2.91
(2.59 to 3.23)
Time Frame Adverse events were recorded for the duration of the trial (1 year).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lithium Carbonate Historical Controls
Hide Arm/Group Description Treated Patients Placebo Patients
All-Cause Mortality
Lithium Carbonate Historical Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   14/109 (12.84%)      44/249 (17.67%)    
Hide Serious Adverse Events
Lithium Carbonate Historical Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/109 (56.88%)      91/249 (36.55%)    
Gastrointestinal disorders     
Gastrointestinal  17/109 (15.60%)  17 23/249 (9.24%)  23
General disorders     
Other  20/109 (18.35%)  20 17/249 (6.83%)  17
Respiratory, thoracic and mediastinal disorders     
Respiratory  25/109 (22.94%)  25 51/249 (20.48%)  51
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lithium Carbonate Historical Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   99/109 (90.83%)      175/249 (70.28%)    
Cardiac disorders     
Cardiovascular  1/109 (0.92%)  46/249 (18.47%)  63
Ear and labyrinth disorders     
Ears, Nose, Throat  6/109 (5.50%)  86/249 (34.54%)  151
Endocrine disorders     
Endocrine/Metabolic  4/109 (3.67%)  8/249 (3.21%)  8
Gastrointestinal disorders     
Gastrointestinal  16/109 (14.68%)  138/249 (55.42%)  406
General disorders     
Other  4/109 (3.67%)  7/249 (2.81%)  8
Musculoskeletal and connective tissue disorders     
Musculoskeletal  6/109 (5.50%)  85/249 (34.14%)  170
Nervous system disorders     
Neurological  27/109 (24.77%)  98/249 (39.36%)  209
Falls  12/109 (11.01%)  72/249 (28.92%)  194
Psychiatric disorders     
Psychological  4/109 (3.67%)  56/249 (22.49%)  83
Reproductive system and breast disorders     
Genitourinary  2/109 (1.83%)  64/249 (25.70%)  109
Respiratory, thoracic and mediastinal disorders     
Respiratory  12/109 (11.01%)  76/249 (30.52%)  123
Skin and subcutaneous tissue disorders     
Dermatological  5/109 (4.59%)  99/249 (39.76%)  211
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Giovanna Kushner
Organization: Forbes Norris MDA/ALS Center
Phone: 415-600-3983
EMail: kushneg@cpmcri.org
Publications:
Layout table for additonal information
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