An Exploratory, Randomized, Double-Blind Clinical Trial of Dipraglurant for Blepharospasm.
Mov Disord
; 39(4): 738-745, 2024 Apr.
Article
em En
| MEDLINE
| ID: mdl-38310362
ABSTRACT
BACKGROUND:
Blepharospasm is treated with botulinum toxin, but obtaining satisfactory results is sometimes challenging.OBJECTIVE:
The aim is to conduct an exploratory trial of oral dipraglurant for blepharospasm.METHODS:
This study was an exploratory, phase 2a, randomized, double-blind, placebo-controlled trial of 15 participants who were assigned to receive a placebo or dipraglurant (50 or 100 mg) and assessed over 2 days, 1 and 2 hours following dosing. Outcome measures included multiple scales rated by clinicians or participants, digital video, and a wearable sensor.RESULTS:
Dipraglurant was well tolerated, with no obvious impact on any of the measurement outcomes. Power analyses suggested fewer subjects would be required for studies using a within-subject versus independent group design, especially for certain measures. Some outcome measures appeared more suitable than others.CONCLUSION:
Although dipraglurant appeared well tolerated, it did not produce a trend for clinical benefit. The results provide valuable information for planning further trials in blepharospasm. © 2024 International Parkinson and Movement Disorder Society.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Blefarospasmo
Tipo de estudo:
Clinical_trials
Limite:
Aged
/
Female
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Humans
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Male
/
Middle aged
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article