Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
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ClinicalTrials.gov Identifier: NCT00818389 |
Recruitment Status :
Terminated
(NINDS DSMB recommended trial be terminated for futility after reviewing an interim analysis of 84 subjects.)
First Posted : January 7, 2009
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
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Sponsor:
Massachusetts General Hospital
Collaborators:
ALS Association
ALS Society of Canada
National Institute of Neurological Disorders and Stroke (NINDS)
University of Toronto
State University of New York - Upstate Medical University
Columbia University
University of Kentucky
Information provided by:
Massachusetts General Hospital
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Amyotrophic Lateral Sclerosis |
Interventions |
Drug: Lithium Carbonate Drug: Riluzole Drug: placebo |
Enrollment | 84 |
Participant Flow
Recruitment Details | Between January 2009 to June 2009, 97 patients were screened and 84 subjects were randomized at 21 clinical sites; 11 in the United States and 10 in Canada. All sites were members of the Northeast ALS Consortium (NEALS) and/or the Canadian ALS Consortium (CALS). |
Pre-assignment Details | All patients were required to be on a stable dose of riluzole for at least 30 days prior to screening. 13 subjects failed screening: 3 due to low lung function test results, 3 due to prohibited medications,3 due to study closure, 2 due to abnormal lab test results and 1 due to death unrelated to the study. |
Arm/Group Title | Lithium + Riluzole | Placebo + Riluzole |
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Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L). | Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding. |
Period Title: Overall Study | ||
Started | 40 | 44 |
Completed | 36 [1] | 38 [2] |
Not Completed | 4 | 6 |
Reason Not Completed | ||
Death | 1 | 3 |
ALS Disease Progression | 1 | 0 |
Withdrawal by Subject | 2 | 2 |
Adverse Event | 0 | 1 |
[1]
4 subjects terminated study early before 1st interim analysis. Study terminated early for futility.
[2]
6 subjects terminated study early before 1st interim analysis. Study terminated early for futility.
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Baseline Characteristics
Arm/Group Title | Lithium + Riluzole | Placebo + Riluzole | Total | |
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Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L). | Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding. | Total of all reporting groups | |
Overall Number of Baseline Participants | 40 | 44 | 84 | |
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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 | 40 participants | 44 participants | 84 participants | |
58.3 (10.2) | 55.5 (11.9) | 56.24 (11.16) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 40 participants | 44 participants | 84 participants | |
Female |
10 25.0%
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20 45.5%
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30 35.7%
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Male |
30 75.0%
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24 54.5%
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54 64.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 40 participants | 44 participants | 84 participants | |
Hispanic or Latino |
0 0.0%
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2 4.5%
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2 2.4%
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Not Hispanic or Latino |
40 100.0%
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42 95.5%
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82 97.6%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 40 participants | 44 participants | 84 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
1 2.5%
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2 4.5%
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3 3.6%
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White |
39 97.5%
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42 95.5%
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81 96.4%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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ALS Functional Rating Scale-Revised (ALSFRS-R)
[1] Mean (Standard Deviation) Unit of measure: Scores on a scale |
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Number Analyzed | 40 participants | 44 participants | 84 participants | |
38.4 (4.6) | 36.5 (5.7) | 37.43 (5.24) | ||
[1]
Measure Description: ALSFRS-R is an ordinal rating scale questionnaire (rating 0-4) used to determine subject's assessment of their capability and independence in 12 functional activities (i.e. this is a patient-reported questionnaire scale of disability). Each question has a rating of 0-4 with 4 being the most functional and 0 being the least functional. The most functional total score is 48.
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Vital Capacity
[1] Mean (Standard Deviation) Unit of measure: Percent of predicted normal |
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Number Analyzed | 40 participants | 44 participants | 84 participants | |
94.0 (18.1) | 86.9 (16.9) | 90.18 (18.20) | ||
[1]
Measure Description: Vital capacity (VC) testing is a measure of lung function that is performed using a standard spirometer and the Slow VC method. Three trials were required (5 maximum); the best of 3 was used.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Elizabeth Simpson |
Organization: | Massachusetts General Hospital |
Phone: | 617-726-3430 |
EMail: | esimpson1@partners.org |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merit Cudkowicz, MD, MSc, Co-Director, Neurology Clinical Trials Unit, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00818389 |
Other Study ID Numbers: |
U01NS049640 ( U.S. NIH Grant/Contract ) 3U01NS049640-04S1 ( U.S. NIH Grant/Contract ) |
First Submitted: | January 6, 2009 |
First Posted: | January 7, 2009 |
Results First Submitted: | May 10, 2010 |
Results First Posted: | April 19, 2011 |
Last Update Posted: | April 19, 2011 |