Clinical trial: Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis (ALS) (NCT00748501)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment