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

2026年5月21日 更新者: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.

調査の概要

状態

募集

介入・治療

研究の種類

介入

入学 (推定)

7

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Hérault
      • Montpellier、Hérault、フランス、34295

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Assessment of motor skills
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Assessment of motor skills
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)

協力者と研究者

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月8日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2025年12月26日

QC基準を満たした最初の提出物

2026年5月21日

最初の投稿 (実際)

2026年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月29日

QC基準を満たした最後の更新が送信されました

2026年5月21日

最終確認日

2026年5月1日

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