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

September 13, 2005
August 14, 2008
January 2001
Not Provided
Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength
Stability at 6, 12, 18 and 24 months on of the patient’s mean percent predicted arm strength
Complete list of historical versions of study NCT00214110 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Amyotrophic Lateral Sclerosis (ALS)
Drug: Tamoxifen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2005
Not Provided

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).
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214110
2000-486
Yes
Benjamin Rix Brooks, MD, University of Wisconswin
University of Wisconsin, Madison
Not Provided
Principal Investigator: Benjamin R Brooks, MD University of Wisconsin, Madison
University of Wisconsin, Madison
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP