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NCT Number: NCT00214110

Tamoxifen Therapy 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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Tamoxifen

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study 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]

Important dates

Study start
2001
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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