Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

• ClinicalTrials.gov Identifier: NCT00214110
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: October 5, 2015
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Amyotrophic Lateral Sclerosis (ALS)	Drug: Tamoxifen	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• 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]
• Study Start Date: January 2001
• Actual Study Completion Date: January 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Vital capacity, raw liters and percent predicted, compared with baseline measured at 3 month intervals.
2. Individual arm and leg muscle mean percent predicted isometric strength compared with baseline measured at 3 month intervals.
3. Bulbar, Breathing, arm and leg subscores of ALS Functional Rating Scale - Revised [ALS-FRS-R] compared with baseline measured at 3 month intervals.
4. Total ALS Functional Rating Scale [ALS-FRS-R] compared with baseline measured at 3 month intervals.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00214110
• Other Study ID Numbers: 2000-486
• First Posted: September 21, 2005
• Last Update Posted: October 5, 2015
• Last Verified: August 2008

Additional relevant MeSH terms:

Amyotrophic Lateral Sclerosis; Tamoxifen; Motor Neuron Disease; Sclerosis; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Bone Density Conservation Agents