Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214110
• Other study ID #: 2000-486
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: October 1, 2015
• Start date: January 2001
• Est. completion date: January 2005

Study information

• Verified date: August 2008
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Tamoxifen

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength
Secondary	Vital capacity, raw liters and percent predicted, compared with baseline measured at 3 month intervals.
Secondary	Individual arm and leg muscle mean percent predicted isometric strength compared with baseline measured at 3 month intervals.
Secondary	Bulbar, Breathing, arm and leg subscores of ALS Functional Rating Scale - Revised [ALS-FRS-R] compared with baseline measured at 3 month intervals.
Secondary	Total ALS Functional Rating Scale [ALS-FRS-R] compared with baseline measured at 3 month intervals.