Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

NCT00214110 | Completed Phase 2 DMC

• 1 other identifier: 2000-486
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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.

Interventions

Tamoxifen DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Benjamin R Brooks, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2001
• Study Completion: January 1, 2005
• Last Updated: October 5, 2015

Record last verified: 2008-08

Locations

US (1)