Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

October 1, 2015 updated by: University of Wisconsin, Madison

Phase 2 Randomized Single-blind Escalating Dose Response Clinical Trial of Tamoxifen Therapy on Mean Percent Predicted Isometric Strength in Amyotrophic Lateral Sclerosis [ALS]

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Benjamin R Brooks, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000-486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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