Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]
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ClinicalTrials.gov Identifier: NCT00214110 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : October 5, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis (ALS) | Drug: Tamoxifen | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Official Title: | Phase 2 Randomized Single-blind Escalating Dose Response Clinical Trial of Tamoxifen Therapy on Mean Percent Predicted Isometric Strength in Amyotrophic Lateral Sclerosis [ALS] |
Study Start Date : | January 2001 |
Actual Study Completion Date : | January 2005 |

- Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength
- Vital capacity, raw liters and percent predicted, compared with baseline measured at 3 month intervals.
- Individual arm and leg muscle mean percent predicted isometric strength compared with baseline measured at 3 month intervals.
- Bulbar, Breathing, arm and leg subscores of ALS Functional Rating Scale - Revised [ALS-FRS-R] compared with baseline measured at 3 month intervals.
- Total ALS Functional Rating Scale [ALS-FRS-R] compared with baseline measured at 3 month intervals.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214110
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Benjamin R Brooks, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00214110 |
Other Study ID Numbers: |
2000-486 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | October 5, 2015 |
Last Verified: | August 2008 |
Amyotrophic Lateral Sclerosis Tamoxifen Motor Neuron Disease Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies |
Proteostasis Deficiencies Metabolic Diseases Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents |