Status:
COMPLETED
Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
This is a single-center, phase 2 randomized clinical trial of tamoxifen on mean percent predicted isometric muscle strength in patients with amyotrophic lateral sclerosis (ALS). The purpose is to dete...
Eligibility Criteria
Inclusion
- clinically probable-laboratory supported, clinically probable, or clinically definite amyotrophic lateral sclerosis
Exclusion
- 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).
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00214110
Start Date
January 1 2001
End Date
January 1 2005
Last Update
October 5 2015
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792