Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Completed · Phase 2
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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
Key facts
- Study ID
- NCT00748501
- Run by
- Sangamo Therapeutics
- People needed
- 45
- Starts
- 2008-09-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2012-11-01
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Coordinated Clinical Research — La Jolla, California, United States
- University of California, Irvine; MDA ALS and Neuromuscular Center, — Orange, California, United States
- California Pacific Medical Center (CPMC), The Forbes Norris MDA/ALS Research Center — San Francisco, California, United States
- The University of Kansas Medical Center (KU) — Kansas City, Kansas, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Nerve and Muscle Center of Texas — Houston, Texas, United States
Full record on ClinicalTrials.gov
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