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Study of L-dopa Treatment in Patients With a Neurodevelopmental Disorder (CTNNB1 Gene) (CTNNB1)

21 de maio de 2026 atualizado por: University Hospital, Montpellier

Prospective Pilot Study of L-dopa Treatment in Patients With a Neurodevelopmental Disorder Related to a Pathogenic Variant of the CTNNB1 Gene

Neurodevelopmental disorders (NDD) encompass conditions that impair cognitive and/or emotional development in children, significantly impacting school, social, and family life. They are often linked to genetic causes and, in most cases, lack curative treatment. Among these disorders, monoallelic variations in the CTNNB1 gene cause a rare syndrome known as NEDSDV (Neurodevelopmental disorder with spastic diplegia and visual defects, OMIM: 615075). About twenty patients are reported in France. This syndrome is characterized by global developmental delay, intellectual disability, axial hypotonia, autistic traits, microcephaly, and sometimes ocular anomalies. The clinical profile resembles that of cerebral palsy, and CTNNB1 syndrome is considered a genetic form of this condition, accounting for roughly 4% of cases where a gene has been identified.

Motor impairment is a core feature, with a wide range of movement disorders. Research remains limited, except for a recent publication. Dystonic hypertonia of the lower limbs is frequently described, more pronounced distally than proximally, without pyramidal signs. Spasticity is less common. Gait has been poorly studied: it may be absent or, when acquired, unstable, often tiptoe, and sometimes broad-based, resembling ataxia despite the absence of cerebellar signs. These motor features are difficult to detect before one year of age. To date, no longitudinal studies exist on motor or cognitive progression in CTNNB1 patients; available data are cross-sectional and do not suggest cognitive decline.

From a pathophysiological perspective, the CTNNB1 gene encodes β-catenin, a key protein in cell adhesion and Wnt signaling, involved in cell differentiation and tissue homeostasis. It plays an essential role in embryonic brain development, particularly neuritogenesis and synaptic organization, with a specific impact on dopaminergic structures in the midbrain. Knock-out animal models show severe reduction in dopaminergic neurogenesis. These findings suggest that CTNNB1 anomalies lead to secondary dopaminergic deficits, contributing to clinical signs. The hypothesis is that this deficit could be partially corrected by dopamine supplementation.

Regarding treatment, L-dopa (levodopa), used in dopaminergic disorders, has shown beneficial effects in a CTNNB1 patient. In our neuropediatrics department, two patients treated with L-dopa exhibited notable improvements in alertness, language, and motor skills within two months. These observations support the hypothesis that L-dopa may improve certain motor and non-motor symptoms in these patients.

In summary, CTNNB1 syndrome is a rare form of NDD, clinically similar to cerebral palsy, with complex motor disorders and a probable dopaminergic deficit. Current evidence calls for further research, including longitudinal studies and therapeutic trials targeting the dopaminergic pathway.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

7

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

    • Hérault
      • Montpellier, Hérault, França, 34295

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Aged between 1 and 15 years inclusive,
  • Carrier of a pathogenic variant of CTNNB1,
  • Patient with dystonia,
  • Patient willing to comply with the contraception requirements detailed in the protocol.

Exclusion Criteria:

  • Contraindication to treatment with L-dopa and carbidopa or any of its excipients,
  • Current treatment with L-dopa, dopamine agonist, or dopamine blocker,
  • Patients with peptic ulcer disease,
  • Patients with open-angle glaucoma,
  • Patients with orthostatic hypotension,
  • Failure to obtain informed consent signed by both parents or legal guardians and the child's assent, if possible,
  • Patients not affiliated with or not covered by a social security scheme,
  • Individuals participating in another study with an exclusion period still in progress,
  • Individuals who are pregnant or wish to become pregnant within 12 months of inclusion.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Participant
Treatment with L-dopa combined with a peripheral decarboxylase inhibitor (carbidopa) will be introduced gradually over a period of one year from the start of treatment. Motor, cognitive, quality of life and tolerance assessments will be carried out before treatment and at 6 and 12 months.
Treatment with L-dopa combined with a peripheral decarboxylase inhibitor (carbidopa) will be introduced gradually over a period of one year from the start of treatment. Motor, cognitive, quality of life and tolerance assessments will be carried out before treatment and at 6 and 12 months.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Assessment of motor skills
Prazo: Baseline and 6 month follow-up visit
Change in overall motor score using the GMFM-88 scale before treatment (D1) and at 6 months.
Baseline and 6 month follow-up visit

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Assessment of motor skills
Prazo: 6 month follow-up visit and end-of-study visit at 12 months
Change in motor skills score using the GMFM-88 scale before treatment (D1) and at 12 months, as well as between 6 months and 12 months
6 month follow-up visit and end-of-study visit at 12 months
Assessment of motor skills
Prazo: Baseline, 6 month follow-up visit and end-of-study visit at 12 months
Changes in the five motor subscores of the five dimensions of the GMFM-88 scale before treatment (D1), at 6 months and 12 months, and between 6 months and 12 months
Baseline, 6 month follow-up visit and end-of-study visit at 12 months
Cognitive assessment
Prazo: Baseline and end-of-study visit at 12 months
Change in developmental scores (Bayley III) from baseline to 12 months after treatment
Baseline and end-of-study visit at 12 months
Cognitive assessment
Prazo: Baseline and end-of-study visit at 12 months
Change in cognitive scores (WPPSI or WISC, according to age) from baseline to 12 months after treatment
Baseline and end-of-study visit at 12 months
Cognitve assessment
Prazo: Baseline and end-of-study visit at 12 months
Change in adaptive behavior scores (Vineland) from baseline to 12 months after treatment
Baseline and end-of-study visit at 12 months
Quality of life assessment
Prazo: Baseline, 6 month follow-up visit and end-of-study visit at 12 months
Change from baseline to Month 6 and Month 12 in quality of life scores (CP-CHILD)
Baseline, 6 month follow-up visit and end-of-study visit at 12 months
Quality of life assessment
Prazo: Baseline, 6 month follow-up ans end-of-study visit at 12 months
Change from baseline to Month 6 and Month 12 in Clinical Global Impression of Severity scores (CGI)
Baseline, 6 month follow-up ans end-of-study visit at 12 months
Assessment of tolerance
Prazo: From baseline to the end-of-study visit at 12 months (continuous assessment throughout the study period)
Number and severity of adverse events from baseline to Month 12
From baseline to the end-of-study visit at 12 months (continuous assessment throughout the study period)
Assessment of tolerance
Prazo: From baseline to the end-of-study visit at 12 months (continuous assessment throughout the study period)
Changes in clinical status based on neurological and osteoarticular examinations from baseline to Month 12
From baseline to the end-of-study visit at 12 months (continuous assessment throughout the study period)
Assessment of tolerance
Prazo: From baseline to the end-of-study visit at 12 months (continuous assessment throughout the study period)
Frequency and severity of patient-reported symptoms (diary) from baseline to Month 12
From baseline to the end-of-study visit at 12 months (continuous assessment throughout the study period)

Colaboradores e Investigadores

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Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de abril de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

26 de dezembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de maio de 2026

Primeira postagem (Real)

29 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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