Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]



Status:Completed
Conditions:Neurology, Neurology, Neurology, ALS
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 90
Updated:4/21/2016
Start Date:January 2001
End Date:January 2005

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Trial Summary
Trial Overview
Inclusion Criteria

Phase 2 Randomized Single-blind Escalating Dose Response Clinical Trial of Tamoxifen Therapy on Mean Percent Predicted Isometric Strength in Amyotrophic Lateral Sclerosis [ALS]

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 determine whether the triphenylethylenetamoxifen, used as adjuvant therapy
in the treatment of breast cancer, can delay the loss of isometric muscle strength in ALS
patients.


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).
We found this trial at
1
site
University of Wisconsin
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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