Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT00818389

Run by

Massachusetts General Hospital

People needed

84

Starts

2009-01-01

Expected to finish

2009-10-01

Last updated by the study team

2011-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Phoenix Neurological Assoc., 1331 N. 7th Street, Suite 350 — Phoenix, Arizona, United States
• Cedars-Sinai ALS Center, Neurology Specialty Clinic, 8730 Alden Drive, Thalians, E 245 — Los Angeles, California, United States
• UCSF ALS Center, University of California San Francisco, Neurology, Box 0114, UCSF — San Francisco, California, United States
• Mayo Clinic-Jacksonville, Neurology Department, 4500 San Pablo Road — Jacksonville, Florida, United States
• University of Miami, Miller School of Medicine, 1150 NW 14th Street, Suite 609 (SCs are suite 701) — Miami, Florida, United States
• Indiana University, Department of Neurology, 1050 Wishard Blvd, RG 6 — Indianapolis, Indiana, United States
• University of Kentucky Medical Center, BAMC, Department of Neurology, Room A307, 1101 Veteran's Drive — Lexington, Kentucky, United States
• Johns Hopkins University, Department of Neurology, 600 N. Wolfe St, Meyer 6-181 — Baltimore, Maryland, United States
• Massachusetts General Hospital, 149 13th St, Room 2266 — Charlestown, Massachusetts, United States
• Wayne State University, Department of Neurology, 4201 St. Antoine, 8C UHC — Detroit, Michigan, United States
• Hennepin County Medical Center, Dept of Neurology, 701 Part Ave S, P5-200 — Minneapolis, Minnesota, United States
• Washington University, 660 S. Euclid Ave., Box 8111 Neurology — St Louis, Missouri, United States
• Columbia Univ Med Ctr, Eleanor and Lou Gehrig ALS/MDA Center, 710 West 168th St, 9th Floor — New York, New York, United States
• SUNY Upstate Medical University, 750 E Adams St, 6610UH — Syracuse, New York, United States
• Duke University Medical Center, Box 3333 — Durham, North Carolina, United States
• Wake Forest University, ALS Center, Paul Sticht Center, Ground Floor, Medical Center Blvd — Winston-Salem, North Carolina, United States
• Ohio State University, Neuromuscular Division, 1654 Uphan Drive, 417 Means Hall — Columbus, Ohio, United States
• Penn State Hershey Medical Center, Department of Neurology, H037, Pennsylvania State Hershey Medical Center — Hershey, Pennsylvania, United States
• Drexel University College of Medicine, 245 North 15th Street — Philadelphia, Pennsylvania, United States
• Texas Neurology, PA, 6301 Gaston Ave, Suite 400 West Tower — Dallas, Texas, United States
• University of Vermont, Department of Neurology, 89 Beaumont Drive, Given Bldg, Room C-225 — Burlington, Vermont, United States
• University of Virginia, Department of Neurology, 3100 Hospital Drive — Charlottesville, Virginia, United States
• University of Calgary, Area 3, University of Calgary Medical Clinic, 3350 Hospital Drive NW Foothills Hosp. Grounds — Calgary, Alberta, Canada
• University of Alberta, Division of Neurology, Dept of Medicine, 2E3.17 Walter C. MacKenzie Health Sciences Center — Edmonton, Alberta, Canada
• University of British Columbia, GF Strong Rehab Centre, 4255 Laurel Street — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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