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
12 de junio de 2026 actualizado por: Hospital General Universitario Gregorio Marañon
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.
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
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
103
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Barcelona, España, 08036
- Reclutamiento
- Hospital Clinic de Barcelona
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Contacto:
- Rosa Calvo, PhD
- Número de teléfono: +34932279974
- Correo electrónico: rcalvo@clinic.cat
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Investigador principal:
- Rosa Calvo, PhD
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Madrid, España, 28007
- Reclutamiento
- Hospital General Universitario Gregorio Marañón
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Contacto:
- Maria José Parellada, PhD
- Número de teléfono: +34 91 4265005
- Correo electrónico: parelladahggm@gmail.com
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Investigador principal:
- María José Parellada, PhD
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Salamanca, España
- Reclutamiento
- Hospital Universitario De Salamanca
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Contacto:
- Ricardo Canal-Bedia, PhD
- Número de teléfono: +34638766776
- Correo electrónico: rcanal@usal.es
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Investigador principal:
- Ricardo Canal-Bedia, PhD
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Zamora, España, 49020
- Reclutamiento
- Complejo Asistencial De Zamora Hospital Provincial De Zamora
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Contacto:
- Manuel Angel Franco, PhD
- Número de teléfono: +34669462622
- Correo electrónico: mfrancom@saludcastillayleon.es
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Investigador principal:
- Manuel Angel Franco, PhD
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Paris, Francia, 75019
- Reclutamiento
- Assistance Publique Hopitaux De Paris
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Contacto:
- Richard Delorme, PhD
- Número de teléfono: +31140034130
- Correo electrónico: richard.delorme@aphp.fr
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Investigador principal:
- Richard Delorme, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Signed Written Informed Consent a.Participants or their legal representative must have signed and dated an IRB/IEC approved written informed consent form
- Diagnosis of an Autism Spectrum Disorder according to the DSM-5 criteria
- Participation in the AIMS-2 CT1 (ages at recruitment 5 to 17).
- Current pharmacological treatment regimen affecting behaviour has been stable for at least 6 weeks prior to screening and is expected to be stable during the duration of the study
- Current psychotherapeutic/psychosocial interventions affecting behaviour stable for 3 months prior to screening and expected to be stable during the duration of the study
- Participants with a history of seizure disorder must currently be receiving stable treatment with anticonvulsant medication and must have been seizure free for 6 months prior to screening or must be seizure free for 3 years prior to screening if not currently on a stable (>3 months) dose of antiepileptics
- Male or female participants 7 to 23 years of age at the time of providing consent, inclusive.
- Reside or regular contact (at least twice a week) with the parent/carer who is interviewed for the study.
- Negative pregnancy test for females of childbearing potential (participant has experienced onset of menses)
- Females of childbearing potential who are sexually active must agree to use a highly effective form of contraception (i.e., existing surgical sterilization, complete or abstinence or a combination of two affective forms of contraception, such as, for example, condoms plus hormonal treatment). Please, refer to Appendix 4 for a complete list of acceptable contraception methods.(protocol)
- Male participants with female partners of childbearing potential are eligible to participate if they agree to the conditions stated in section 8.2.1.(protocol)
Exclusion Criteria:
- Participants with any condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
- Participants who are currently receiving treatment with racemic baclofen, vigabatrin, tiagabine, or riluzole or other GABA-related medications (e.g. gabapentin or pregabalin) other than arbaclofen in the context of AIMS-2 CT1
- Participants who are currently receiving pharmacologic treatment affecting behaviour (see concomitant medication section) need to have a stable dose during the 6 weeks prior to the screening visit and for the duration of the study.
- Participating in programs including non-pharmacologic educational, behavioural, and/or dietary interventions affecting behaviour, participation in these programs must have been continuous during the 3 months prior to screening and participants or their parent/caregiver/LAR may not electively initiate new or modify ongoing interventions for the duration of the study. Typical school vacations are not considered modifications of stable programming
- Participants who have taken another investigational drug within the last 30 days.
- Participants with evidence of any significant haematological, endocrine, cardiovascular (including uncorrected symptomatic congenital heart disease), respiratory, renal, hepatic, or gastrointestinal disease, not including mild common paediatric diseases in these areas that are stable (e.g. mild asthma, constipation, etc.), as judged by the investigator.
- Participants who are not able to take oral medications.
- Participants who have a history of hypersensitivity to racemic baclofen
- Participants with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption should not take this medicine.
- Active peptic ulceration as Baclofen stimulates gastric acid secretion.
- Porphyria.
- Participants who are currently engaged in illicit drug use or alcohol abuse, according to DSM-5 criteria.
- Participants who have previously participated in a clinical trial with arbaclofen (other than our AIMS-2-CT1).
- Women who are breastfeeding
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: placebo
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initial single dose placebo
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Experimental: arbaclofen
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initial single dose arbaclofen
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in power in the low frequency bands (theta/alpha) (between visits 1 and 2).
Periodo de tiempo: baseline to day 7
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To predict long term response to arbaclofen based on a single dose response during the placebo-controlled randomized single dose double blind stage.
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baseline to day 7
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Latency of N170 change (between visits 1 and 2).
Periodo de tiempo: baseline to day 7
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To test the effect of arbaclofen on an EEG biomarker for response to faces during the placebo-controlled randomized single dose double blind stage.
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baseline to day 7
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Change of Autism Impact Measure (AIM total (Kanne et al., 2014b, Silkey et al., 2023) and subscales. • Change in the Social Responsiveness Scale (SRS total and subscales; Constantino & Gruber, 2012a).
Periodo de tiempo: from baseline to end of treatment
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To explore the effect of arbaclofen on other measures of defining features of autism.
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from baseline to end of treatment
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Change in power in the higher frequency bands (gamma/beta); connectivity in the theta and alpha bands; (between visits 1 and 2).
Periodo de tiempo: baseline to day 7
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To explore EEG marker sensitive to excitatory/inhibitory changes.
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baseline to day 7
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de noviembre de 2025
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
17 de marzo de 2025
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AIMS-2-CT2
- 2023-508407-20-00 (Otro identificador: EU Clinical trials registry)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified data will be entered in a GDPR compliant EDC by individual sites, and after thorough checks shared with the sponsor, according to the CTA. Data will possibly be shared after thorough data cleaning and checks of de-identification of individuals, with other parties of the consortium, if participants have agreed to that in the Informed Consent Form.
Examples of these data would be EEG data, that would be uploaded in a secured server, and analysed by a consortium partner.
Marco de tiempo para compartir IPD
365 days after study finalizes
Tipo de información de apoyo para compartir IPD
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .