Clinical trial: Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS) (NCT00818389)

Eligibility criteria:
Inclusion Criteria:

          -  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 Criteria:

          -  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? 1