A Randomized Phase 2 KINETIC Trial Evaluating SAGE-324/BIIB124 in Individuals with Essential Tremor.
Mov Disord
; 39(4): 733-738, 2024 Apr.
Article
in En
| MEDLINE
| ID: mdl-38357797
ABSTRACT
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 11 to orally receive 60 mg of SAGE-324/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 TETRAS-PS 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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Essential Tremor
Type of study:
Clinical_trials
Limits:
Adolescent
/
Adult
/
Aged
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Aged80
/
Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
Mov Disord
Journal subject:
NEUROLOGIA
Year:
2024
Type:
Article
Affiliation country:
United States