Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Key Inclusion 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.
Key Exclusion Criteria:
* 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%.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/14/2024. Questions regarding updates should be directed to the study team contact.