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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

NCT07655115 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2026-06-17

No results posted yet for this study

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

Conditions

  • Autism Spectrum Disorders

Interventions

DRUG

Arbaclofen

initial single dose arbaclofen

OTHER

Placebo

initial single dose placebo

Sponsors & Collaborators

  • Fundación para la Investigación Biomédica del Hospital Gregorio Maranon

    collaborator OTHER

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
0 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France
  • Spain

Study Locations

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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 NCT07655115 on ClinicalTrials.gov