Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis (ALS) (ALS)
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ClinicalTrials.gov Identifier: NCT00748501 |
Recruitment Status :
Completed
First Posted : September 8, 2008
Last Update Posted : November 1, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Drug: SB-509 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Repeat-Dosing Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Cohort 1
SB-509 drug administration via IM injection of neck, arms, and legs
|
Drug: SB-509
Intramuscular injection of 60 mg of SB-509. Two doses on Day 0 and Day 90. |
Active Comparator: Cohort 2
SB-509 drug administration via IM injection of legs
|
Drug: SB-509
Intramuscular injection of 60 mg of SB-509. Two doses on Day 0 and Day 90. |
- 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). [ Time Frame: 11 months ]
- 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. [ Time Frame: 11 months ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748501
United States, California | |
Coordinated Clinical Research | |
La Jolla, California, United States, 92037 | |
University of California, Irvine; MDA ALS and Neuromuscular Center, | |
Orange, California, United States, 92868 | |
California Pacific Medical Center (CPMC), The Forbes Norris MDA/ALS Research Center | |
San Francisco, California, United States, 94115 | |
United States, Kansas | |
The University of Kansas Medical Center (KU) | |
Kansas City, Kansas, United States, 66160 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Texas | |
Nerve and Muscle Center of Texas | |
Houston, Texas, United States, 77030 |
Study Director: | Ely Benaim, M.D. | Sangamo Therapeutics |
Responsible Party: | Sangamo Therapeutics |
ClinicalTrials.gov Identifier: | NCT00748501 |
Other Study ID Numbers: |
SB-509-0801 |
First Posted: | September 8, 2008 Key Record Dates |
Last Update Posted: | November 1, 2012 |
Last Verified: | October 2012 |
Amyotrophic Lateral Sclerosis, ALS, Lou Gehrig's Disease |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |