MedTrace Logo

Arbaclofen in Children and Adolescents With ASD

NCT03682978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2023-02-08

No results posted yet for this study

Summary

AIMS-2-CT-01 is a randomized, double-blind, placebo controlled, study to explore the efficacy, safety and tolerability of Arbaclofen administered to children and adolescents (ages 5-17) for the treatment of social adaptive function in participants with ASD. The effects of Arbaclofen on social function in children and adolescents with ASD will be evaluated in a randomized, placebo controlled, parallel-group study of 16 weeks duration. Subjects who meet protocol criteria will be randomly allocated to receive either Arbaclofen or placebo in a 1:1 ratio in the Treatment Period. There will be 7 recruiting sites and randomization will be stratified by site. A sample of 130 patients will be recruited. Blinding will be maintained by utilizing identical tablets containing either Arbaclofen or placebo.

Conditions

Interventions

DRUG

Arbaclofen

Arbaclofen tablet.

DRUG

Placebo

Placebo tablet.

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Celso Arango, MD, PhD

    lead OTHER

Principal Investigators

  • Celso Arango, Prof. · Hospital General Universitario Gregorio Marañón

  • Mara Parellada, Prof. · Hospital General Universitario Gregorio Marañón

  • Richard Delorme, Prof. · Hopital Universitaire Robert-Debre

  • Jeremy Parr, Prof. · University of Newcastle Upon-Tyne

  • Mallika Punukollu, Dr. · University of Glasgow

  • Andre Strydom, Prof. · King's College London

  • Rosa Calvo, Dr. · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2023-01-27
Completion
2023-01-27

Countries

  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682978 on ClinicalTrials.gov