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RECRUITING
NCT07655115
PHASE3

Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th

Sponsor: Hospital General Universitario Gregorio Marañon

View on ClinicalTrials.gov

Summary

study with arbaclofen (4 weeks of titration and then 6 weeks of active/stable treatment). The effects of arbaclofen on target EEG and ERG metrics will be associated with the clinical response in measures of social and general function, adaptive behaviour, social anxiety, sensory behaviours, global functioning, and quality of life in Children and Adolescents with Autism Spectrum Disorders

Official title: A Follow-Up Shiftability Study of Arbaclofen With an Open-Label Extension for the Study of Biomarkers in Children and Adolescents With Autism Spectrum Disorders.

Key Details

Gender

All

Age Range

0 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2025-11-20

Completion Date

2026-12-31

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

DRUG

Arbaclofen

initial single dose arbaclofen

OTHER

Placebo

initial single dose placebo

Locations (5)

Assistance Publique Hopitaux De Paris

Paris, France

Hospital Clinic De Barcelona

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario De Salamanca

Salamanca, Spain

Complejo Asistencial De Zamora Hospital Provincial De Zamora

Zamora, Spain