Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

University of Wisconsin, Madison100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

100

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

TamoxifenDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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).

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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