A Randomized Phase 2 KINETIC Trial Evaluating SAGE-324/ BIIB124 in Individuals with Essential Tremor.
In: Movement Disorders, Jg. 39 (2024-04-01), Heft 4, S. 733-738
academicJournal
Zugriff:
Background: SAGE-324/BIIB124 is an investigational positive allosteric modulator of GABAA receptors. Objective: KINETIC (NCT04305275), a double-blind, randomized, placebo-controlled, phase 2 study, evaluated SAGE-324/BIIB124 in individuals with essential tremor (ET). Methods: Individuals aged 18 to 80 years were randomly assigned 1:1 to orally receive 60 mg of SAGE324/BIIB124 or placebo once daily for 28 days. The primary endpoint was change from baseline in The Essential Tremor Rating Assessment Scale-Performance Subscale (TETRAS-PS) Item 4 (upper-limb tremor) at day 29 with SAGE-324/BIIB124 versus placebo. Results: Between May 2020 and February 2021, 69 U.S. participants were randomly assigned to receive SAGE-324/BIIB124 (n = 34) or placebo (n = 35). There was a significant reduction from baseline in TETRASPS Item 4 at day 29 with SAGE-324/BIIB124 versus placebo (least squares mean [standard error]: –2.31 [0.401] vs. –1.24 [0.349], P = 0.0491). The most common treatment-emergent adverse events included somnolence, dizziness, fatigue, and balance disorder. Conclusion: These results support further development of SAGE-324/BIIB124 for potential ET treatment. © 2024 Sage Therapeutics, Inc and The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]
Titel: |
A Randomized Phase 2 KINETIC Trial Evaluating SAGE-324/ BIIB124 in Individuals with Essential Tremor.
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Autor/in / Beteiligte Person: | Elble, Rodger J. ; Ondo, William G. ; Lyons, Kelly E. ; Qin, Min ; Garafola, Svetlana ; Hersh, Bonnie ; Lieu, Tina ; Marie ; Arkilo, Dimitrios ; Chuang, Rosalind ; Bankole, Kemi ; Pahwa, Rajesh |
Zeitschrift: | Movement Disorders, Jg. 39 (2024-04-01), Heft 4, S. 733-738 |
Veröffentlichung: | 2024 |
Medientyp: | academicJournal |
ISSN: | 0885-3185 (print) |
DOI: | 10.1002/mds.29731 |
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