Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis (ALS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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Tamoxifen

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No