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

21. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

7

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Hérault
      • Montpellier, Hérault, Frankrike, 34295

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of motor skills
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of motor skills
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

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Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

8. april 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

26. desember 2025

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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