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]

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00214110

Enrollment

100

Registered

2005-09-21

Start date

2001-01-31

Completion date

2005-01-31

Last updated

2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Brief summary

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.

Interventions

DRUGTamoxifen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026