Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Subject must have been diagnosed SPS per the following criteria:
- * Rigidity of limb and axial (trunk) muscles prominent in the abdominal and thoracolumbar paraspinal areas and making bending difficult
- * Clinical or electrophysiological evidence of continuous contraction of agonist and antagonist muscles
- * Episodic spasms precipitated by unexpected noises, tactile stimuli, or emotional upset
- * Absence of any other neurologic disease that could explain the stiffness and rigidity
- * High titer serum anti-GAD65 antibodies shown at screening -OR- seropositive for anti-glycine antibodies. If anti-GAD65 antibodies are lower than the high titer threshold peripherally but positive in the cerebrospinal fluid (CSF), the subject can be included. A prior documented high titer anti-GAD65 antibody level may be acceptable subject to sponsor review.
- * Active symptoms with inadequate response to at least one immunomodulatory therapy.
- * Stiffness index ≥2.
- * At least 20 of the 25 enrolled subjects should be ambulatory.
- * Bedridden subjects for more than 3 months.
- * History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-SPS progressive neurologic condition or progressive multifocal leukoencephalopathy (PML).
- * History of stroke, seizure, dementia, Parkinson's disease, cerebellar diseases, psychosis, aphasia, and any other neurologic disorder that is of a nature and severity that the investigator considers would increase the risk for the subject.
- * Cardiac ejection fraction ≤ 40%.
Ages Eligible for Study
18 Years to 75 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No