Status:
COMPLETED
Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Sangamo Therapeutics
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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
Detailed Description
SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a study doctor injects SB-509 into the muscles of your neck, arms and/or legs, the drug enters the muscle and nerve ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00748501
Start Date
September 1 2008
End Date
June 1 2010
Last Update
November 1 2012
Active Locations (6)
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1
Coordinated Clinical Research
La Jolla, California, United States, 92037
2
University of California, Irvine; MDA ALS and Neuromuscular Center,
Orange, California, United States, 92868
3
California Pacific Medical Center (CPMC), The Forbes Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
4
The University of Kansas Medical Center (KU)
Kansas City, Kansas, United States, 66160