Trial record 2 of 2 for:    lithium multiple sclerosis

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Forbes Norris MDA/ALS Research Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Muscular Dystrophy Association
Information provided by:
Forbes Norris MDA/ALS Research Center
ClinicalTrials.gov Identifier:
NCT00790582
First received: November 12, 2008
Last updated: March 11, 2009
Last verified: March 2009
  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)

Resource links provided by NLM:


Further study details as provided by Forbes Norris MDA/ALS Research Center:

Primary Outcome Measures:
  • ALSFRS-R [ Time Frame: Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790582

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
Sponsors and Collaborators
Forbes Norris MDA/ALS Research Center
Muscular Dystrophy Association
Investigators
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
Lithium
Lithium Carbonate
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
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 September 14, 2014