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

21 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

7

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assessment of motor skills
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assessment of motor skills
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

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Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 april 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

26 december 2025

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

21 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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