Does treatment with arbaclofen help improve social function in autism?
Research type
Research Study
Full title
A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents with Autism Spectrum Disorders.
IRAS ID
240188
Contact name
Celso Arango
Contact email
Sponsor organisation
SERMAS - Servicio Madrileno de Salud
Eudract number
2018-000942-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 31 days
Research summary
The aim of the study is to explore the efficacy, safety and tolerability of arbaclofen for the treatment of problems in social function in children and adolescents (ages 5-17) who have autism spectrum disorders (ASD).
The medication will be tested in a randomized, placebo-controlled trial lasting 16 weeks. Participants who are eligible will be allocated by chance (randomised) to receive either arbaclofen or placebo in a 1:1 ratio. We aim to include 130 individuals with ASD. The study will be double blind - i.e. neither investigators nor participants will know whether they are allocated to the medication or placebo arm. Blinding will be maintained by using identical tablets (same size, taste, look) containing either arbaclofen or placebo.
This study will be combined with a trial to be conducted in Canada with comparable protocol with a total sample of 220 subjects (90 recruited in Canada and 130 in Europe).REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0335
Date of REC Opinion
28 May 2019
REC opinion
Further Information Favourable Opinion