Know Cancer

or
forgot password

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


Phase 2
18 Years
90 Years
Not Enrolling
Both
Amyotrophic Lateral Sclerosis (ALS)

Thank you

Trial Information

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


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Benjamin R Brooks, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

2000-486

NCT ID:

NCT00214110

Start Date:

January 2001

Completion Date:

January 2005

Related Keywords:

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

Name

Location

University of WisconsinMadison,, Wisconsin  53792-5666