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.
|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]|
- Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength
- 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.
|Study Start Date:||January 2001|
|Study Completion Date:||January 2005|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Benjamin R Brooks, MD||University of Wisconsin, Madison|