Amyotrophic Lateral Sclerosis Clinical Trial
— ALSOfficial title:
A Phase 2 Repeat-Dosing Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis
Verified date | October 2012 |
Source | Sangamo Biosciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 45 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Nerve and Muscle Center of Texas | Houston | Texas |
United States | The University of Kansas Medical Center (KU) | Kansas City | Kansas |
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Sangamo Biosciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the effect of SB-509 on progression of the disease in subjects with ALS, as measured by the ALS Functional Rating Scale -Revised (ALSFRS-R). | 11 months | No | |
Secondary | To evaluate a) the effect of SB-509 on Forced Vital Capacity, Neurophysiologic Index, Manual Muscle Test, and survival. b) safety and tolerability of SB-509 in ALS. c) stem cell mobilization in subjects with ALS receiving SB-509. | 11 months | Yes |
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