Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214110
First received: September 13, 2005
Last updated: August 14, 2008
Last verified: August 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
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]

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on August 28, 2014