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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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12 October 2015 |
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Main ID: |
NCT00214110 |
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Date of registration:
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13/09/2005 |
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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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Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]
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Scientific title:
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Phase 2 Randomized Single-blind Escalating Dose Response Clinical Trial of Tamoxifen Therapy on Mean Percent Predicted Isometric Strength in Amyotrophic Lateral Sclerosis [ALS] |
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Date of first enrolment:
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January 2001 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00214110 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Benjamin R Brooks, 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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University of Wisconsin, Madison |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- clinically probable-laboratory supported, clinically probable, or clinically definite
amyotrophic lateral sclerosis
Exclusion Criteria:
- Allergic or idiosyncratic response to tamoxifen.
- Other active neurologic diseases that may produce weakness, sensory loss, or
autonomic symptoms.
- Psychiatric, psychological, or behavioral symptoms that would interfere with the
subject's ability to participate in the trial.
- Clinically significant cardiac, pulmonary, gastrointestinal, hematologic, or
endocrine (poorly controlled insulin-dependent diabetes mellitus or hyperthyroidism)
disease that may confound interpretation of the study results.
- Previous kidney or pancreas transplants.
- Significant hepatic or renal disease (AST > 5 times normal, serum creatinine > 2.0
mg/dL for males or > 1.8 mg/dL for females).
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis (ALS)
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Intervention(s)
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Drug: Tamoxifen
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Primary Outcome(s)
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Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength
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Secondary Outcome(s)
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Bulbar, Breathing, arm and leg subscores of ALS Functional Rating Scale - Revised [ALS-FRS-R] compared with baseline measured at 3 month intervals.
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Vital capacity, raw liters and percent predicted, compared with baseline measured at 3 month intervals.
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Individual arm and leg muscle mean percent predicted isometric strength compared with baseline measured at 3 month intervals.
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Total ALS Functional Rating Scale [ALS-FRS-R] compared with baseline measured at 3 month intervals.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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