Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

Phase 2

Completed

• Conditions: Amyotrophic Lateral Sclerosis (ALS)

• Registration Number: NCT00214110
• Lead Sponsor: University of Wisconsin, Madison

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Study Completion: 2005-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2008-08
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• clinically probable-laboratory supported, clinically probable, or clinically definite amyotrophic lateral sclerosis

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States