Status:
TERMINATED
Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
ALS Association
ALS Society of Canada
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to compare the effectiveness of lithium combined with riluzole to riluzole combined with placebo in people with amyotrophic lateral sclerosis.
Detailed Description
Amyotrophic lateral sclerosis (ALS) is a rare, neurodegenerative disorder that results in progressive wasting and paralysis of voluntary muscles. In this double blind, randomized, placebo-controlled ...
Eligibility Criteria
Inclusion
- Familial or sporadic ALS
- Participants diagnosed with laboratory supported probable, clinically possible, probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria
- Disease duration from symptom onset no greater than 36 months at the Screening Visit
- Age 18 years or older
- Capable of providing informed consent and complying with trial procedures
- On a stable dose of riluzole 50 milligrams (mg) twice per day(bid) for at least 30 days prior to screening
- Vital capacity (VC) equal to or more than 60% predicted normal value for gender, height and age at the Screening Visit
- Creatinine \<1.5 milligrams per deciliter (mg/dl) \[133 micromoles per liter (umol/L\]
- Participants maintained on thyroid medication must be euthyroid for at least 3 months before the Screening Visit.
- Participants with psoriasis must have inactive disease for at least 30 days before the Screening Visit.
- Women must not be able to become pregnant (e.g., post menopausal for at least one year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and be non-lactating.
- Geographic accessibility to the study site
Exclusion
- History of known sensitivity or intolerability to lithium or to any other related compound
- Prior exposure to lithium within 90 days of the Screening Visit
- Exposure to any investigational agent within 30 days of the Screening Visit
- Participants who are malnourished, dehydrated or on a sodium-free diet will be excluded due to the potential side effects of lithium carbonate
- Use of digoxin or iodide salts \[e.g. calcium iodide, hydrogen iodide (hydriodic acid), iodide, iodinated glycerol (Organidin), iodine, potassium iodide (SSKI), and sodium iodide supplementation beyond table salt\]
- Presence of any of the following clinical conditions: Substance abuse within the past year; Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease; autoimmune deficiency syndrome (AIDS) or AIDS-related complex; Clinically active psoriasis within 30 days of the Screening Visit; Unstable psychiatric illness defined as psychosis (hallucinations or delusions) or untreated major depression within 90 days of the Screening Visit; Screening serum creatinine greater than or equal to 1.5 mg/dL (133 umol/L), thyroid stimulating hormone (TSH) \> 20% above the upper limit; Presence of any clinically significant conduction abnormalities on electrocardiogram (ECG); or Lactating or have a positive serum pregnancy test at the Screening Visit.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00818389
Start Date
January 1 2009
End Date
October 1 2009
Last Update
April 19 2011
Active Locations (37)
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1
Phoenix Neurological Assoc., 1331 N. 7th Street, Suite 350
Phoenix, Arizona, United States, 85006
2
Cedars-Sinai ALS Center, Neurology Specialty Clinic, 8730 Alden Drive, Thalians, E 245
Los Angeles, California, United States, 90048
3
UCSF ALS Center, University of California San Francisco, Neurology, Box 0114, UCSF
San Francisco, California, United States, 94143
4
Mayo Clinic-Jacksonville, Neurology Department, 4500 San Pablo Road
Jacksonville, Florida, United States, 32224