Study Purpose:The purpose of the study is to evaluate the effects of the investigational drug, SB-509 on progression of the disease in subjects with ALS
Amyotrophic Lateral Sclerosis
Type of Intervention:
Study Chair(s)/Principal Investigator(s):
Ely Benaim, M.D., Sangamo Therapeutics
Coordinating Center Contact Information
Sangamo Biosciences, Inc.
California, United States
Full Study Summary:
Estimated Study Start Date:
08 / 31 / 2008
Estimated Study Completion Date:
06 / 01 / 2010
Posting Last Modified Date:
11 / 01 / 2012
Date Study Added to neals.org:
09 / 08 / 2008
Can participants use Riluzole?
- Male or female between the ages of 18 and 85 with clinical diagnosis of ALS
- Forced Vital Capacity (FVC) > 60% of predicted
- Less than 3 years of ALS since the onset of the first symptom with clinical evidence of limb muscle atrophy and weakness.
- Subjects taking Riluzole must have been at a stable dose for at least 30 days with no evidence of toxicity
- Female of childbearing potential and male of child-creating potential must agree to use a medically acceptable physical barrier (condom, diaphragm, and cervical cap) through the treatment phase and for at least 30 days after the last study treatment.
- Women who are pregnant or currently breast-feeding
- Dependent upon invasive or non-invasive artificial ventilation
- Patients with bulbar onset ALS or with other active neuromuscular/ neurodegenerative diseases.
- Type 1 or Type 2 diabetes.
- Evidence of chronic or active heart, liver, kidney, or lung diseases, or Age-related macular degeneration.
- Current or history of known immune or immunodeficiency disorders
- Patients with cognitive impairment with significant decision making incapacity, or major depression, or schizophrenia, or dementia (e.g. Alzheimer's disease).
- Malignancy or history of malignancy, except it has been in complete remission for at least 5 years
- Pre-cancerous conditions (e.g. Barrett's Esophagus, dysplasias) or benign tumors which have the potential for significant growth due to VEGF stimulation.
Coordinated Clinical Research
La Jolla, California
University of California, Irvine; MDA ALS and Neuromuscular Center,
California Pacific Medical Center (CPMC), The Forbes Norris MDA/ALS Research Center
San Francisco, California
The University of Kansas Medical Center (KU)
Kansas City, Kansas
Johns Hopkins University
Nerve and Muscle Center of Texas