Synthetic pharmaceutical grade cannabidiol for treatment of refractory infantile spasms: A multicenter phase-2 study.
Epilepsy Behav
; 102: 106826, 2020 01.
Article
em En
| MEDLINE
| ID: mdl-31816477
ABSTRACT
PURPOSE:
Limited data suggest that cannabidiol (CBD) may be effective for treatment of refractory infantile spasms (IS). This study was designed to more rigorously evaluate the efficacy and safety of synthetic CBD in the treatment of IS.METHODS:
Children six to 36â¯months of age with IS that failed treatment with both adrenocorticotropic hormone (ACTH) and vigabatrin (VGB) were eligible for enrollment. Children receiving clobazam were excluded. After baseline overnight video-electroencephalography (vEEG) to confirm diagnosis and ascertain hypsarrhythmia, patients were treated with synthetic CBD oral solution (20â¯mg/kg/day). Overnight video-EEG was repeated after 14â¯days, and both baseline and repeat video-EEGs were completely de-identified and reviewed in a pairwise fashion by an independent, blinded pediatric electroencephalographer. The primary efficacy endpoint was freedom from spasms and hypsarrhythmia on day 14.RESULTS:
Nine patients were enrolled, comprising an older (median ageâ¯=â¯23â¯months) cohort with long-standing IS (median durationâ¯=â¯13â¯months) and numerous prior treatment failures (medianâ¯=â¯6). One patient responded to therapy and eight patients exhibited neither clinical nor electrographic response.CONCLUSIONS:
The immediate but temporary response in a single patient suggests that CBD oral solution is not particularly effective in highly refractory cases, but may, nevertheless, be effective in younger patients with shorter durations of IS. Further study, examining both short- and long-term outcomes, is warranted to further evaluate the efficacy and safety of CBD oral solution in the treatment of IS.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Espasmos Infantis
/
Canabidiol
/
Avaliação de Resultados em Cuidados de Saúde
/
Epilepsia Resistente a Medicamentos
/
Anticonvulsivantes
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Incidence_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Child, preschool
/
Female
/
Humans
/
Infant
/
Male
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article