Zuranolone as an oral adjunct to treatment of Parkinsonian tremor: A phase 2, open-label study
نویسندگان
چکیده
Parkinson's disease (PD) is characterized by both motor and nonmotor deficits. Among cardinal symptoms of this disorder, tremor the least responsive to dopamine replacement therapy often undertreated. Zuranolone (SAGE-217) an investigational oral neuroactive steroid (NAS) gamma-aminobutyric acid A (GABAA) receptor–positive allosteric modulator (PAM) that has been investigated for its safety efficacy in patients with PD. In current open-label study, zuranolone capsules (20 30 mg) were administered 7 days 14 (mean age, 65.1 years; mean time since PD diagnosis, 9 years). The primary endpoint was reduction symptoms, as assessed change from baseline Movement Disorder Society-Unified Disease Rating Scale (MDS-UPDRS) Part II/III Tremor Scores on Day 8. Additional endpoints included improvements overall aspects daily living. Adverse events (AEs) also monitored. MDS-UPDRS Score improved 40% (P < 0.0001) score, experiences living (nM-EDL), (m-EDL) scores (MDS-UPDRS Parts I II, respectively), No serious AEs reported, no discontinued treatment. most common dizziness, sedation, somnolence. generally well tolerated who stable doses concurrent dopaminergic agents. These data support further investigation NAS GABAA receptor PAMs adjunctive treatments
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ژورنال
عنوان ژورنال: Journal of the Neurological Sciences
سال: 2021
ISSN: ['0022-510X', '1878-5883']
DOI: https://doi.org/10.1016/j.jns.2020.117277