Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS] - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00214110

Purpose

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.

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis (ALS)	Drug: Tamoxifen	Phase II

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Drug Information available for: Tamoxifen Tamoxifen citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Parallel Assignment
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]

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	100
Study Start Date:	January 2001
Study Completion Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214110

Locations

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Benjamin R Brooks, MD

University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconswin ( Benjamin Rix Brooks, MD )
Study ID Numbers:	2000-486
Study First Received:	September 13, 2005
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00214110
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Amyotrophic lateral sclerosis
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases
Lou Gehrig's disease

Sclerosis
Degenerative motor system disease
Neurodegenerative Diseases
Tamoxifen
Motor neuron disease
Motor Neuron Disease

Additional relevant MeSH terms:

Estrogen Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Nervous System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Pathologic Processes
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009