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A Follow-Up Shiftability Study of Arbaclofen with an Open-Label Extension for the study of Biomarkers for Treatment for Social Function in Children and Adolescents with Autism Spectrum Disorders

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508407-20-00
Acronym
AIMS-2-CT2
Enrollment
105
Registered
2024-09-23
Start date
2025-11-20
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autism spectrum disorder

Brief summary

Change in power in the low frequency bands (theta/alpha) (between visits 1 and 2).

Detailed description

Latency of N170 change (between visits 1 and 2)

Interventions

DRUGARBACLOFEN 10mg
DRUGARBACLOFEN 5mg
DRUGARBACLOFEN 15mg
DRUGARBACLOFEN 20mg

Sponsors

Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Change in power in the low frequency bands (theta/alpha) (between visits 1 and 2).

Secondary

MeasureTime frame
Latency of N170 change (between visits 1 and 2)

Countries

France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026