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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00818389 |
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Date of registration:
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06/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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A Multicenter, Double-Blind, Placebo-Controlled, Study to Investigate the Safety and Efficacy of Lithium in Combination With Riluzole in Volunteers With Amyotrophic Lateral Sclerosis (ALS) |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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84 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00818389 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Jinsy Andrews, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University, New York, NY |
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Name:
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Swati Aggarwal, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Name:
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Merit Cudkowicz, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Name:
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Lorne Zinman, MD, MSc, FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sunnybrook Health Sciences Center, Univ. of Toronto, Toronto, CA |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Lithium Carbonate
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Drug: Riluzole
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Drug: placebo
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Primary Outcome(s)
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Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R)
[Time Frame: 9 months: Baseline to study termination (January 2009 - October 2009)]
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Secondary Outcome(s)
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Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R)
[Time Frame: 9 months: Baseline to study termination (January 2009 - October 2009)]
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Vital Capacity (VC) (Percent of Predicted Normal)
[Time Frame: 9 months: Baseline to study termination (January 2009- October 2009)]
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Secondary ID(s)
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U01NS049640
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3U01NS049640-04S1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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