A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Recruitment status was Active, not recruiting
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Purpose
This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease. Since there is no placebo in this study, all patients will be taking lithium carbonate.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis |
Drug: lithium carbonate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS) |
- ALSFRS-R [ Time Frame: Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13 ] [ Designated as safety issue: No ]
- Vital Capacity [ Time Frame: Screen, Baseline, Month 1,3,6,9,12 ] [ Designated as safety issue: No ]
- Safety Labs [ Time Frame: Screen, Baseline, Month 1,3,6,12 ] [ Designated as safety issue: Yes ]
- Adverse Events [ Time Frame: Month 1,3,6,9,12 ] [ Designated as safety issue: Yes ]
- Lithium Level (blood) [ Time Frame: Week 2, Month 1,6,12 and 2 weeks after a dose change ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: lithium carbonate |
Drug: lithium carbonate
The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
|
Detailed Description:
This is a Phase II Screening study. There is no placebo (inactive or 'fake' drug) in this study, meaning that all participants will be taking lithium carbonate. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease.
A recent article was published in a highly regarded medical journal that showed a positive effect of lithium carbonate on an ALS type mouse. The researchers then studied a very small number of people with ALS, giving 16 people lithium carbonate with riluzole and giving 28 people only riluzole. The people who took lithium remained stronger for a considerably longer period of time. However, the study was very small and we cannot really tell if lithium works unless a larger study is performed. It is not well understood why lithium carbonate might be helpful but it is believed that it may play a role in protecting the motor nerves from the damage of ALS.
If you choose to participate, you will need to go to your study clinic for research study visits 7 times in one year and you will have 4 telephone interviews during that time. These visits and phone calls could take up to 17 hours in total.
Caution: Lithium is an FDA approved drug used for some psychiatric disorders. It is not FDA approved for ALS. Lithium has many potentially serious side effects and must only be taken under close supervision of your physician.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arizona | |
| Mayo Clinic | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| UCLA Neuromuscular Research Center | |
| Los Angeles, California, United States, 90095 | |
| UC Irvine MDA/ALS & Neuromuscular Center | |
| Orange, California, United States, 92868 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| United States, Kansas | |
| Kansas University Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Missouri | |
| Washington University Department of Neurology | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Oregon | |
| Providence ALS Clinic | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| University of Pennsylvania Neurological Institute | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Methodist Neurological Institute | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah Clinical Neurosciences Center | |
| Salt Lake City, Utah, United States, 84132 | |
| Study Director: | Robert G Miller, MD | California Pacific Medical Center |
More Information
Publications:
| Responsible Party: | Robert G. Miller MD / Director, Forbes Norris MDA/ALS Research Center at California Pacific Medical Center |
| ClinicalTrials.gov Identifier: | NCT00790582 History of Changes |
| Other Study ID Numbers: | 28.013 |
| Study First Received: | November 12, 2008 |
| Last Updated: | March 11, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Forbes Norris MDA/ALS Research Center:
|
ALS Amyotrophic Lateral Sclerosis Lou Gehrig's Disease Lithium Lithium Carbonate |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes Lithium |
Lithium Carbonate Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antimanic Agents Antidepressive Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013