- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07614126
Study of L-dopa Treatment in Patients With a Neurodevelopmental Disorder (CTNNB1 Gene) (CTNNB1)
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.
Panoramica dello studio
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Agathe Roubertie, Pr.
- Numero di telefono: +33 4.67.33.01.82
- Email: a-roubertie@chu-montpellier.fr
Backup dei contatti dello studio
- Nome: Bérénice Lecardonnel
- Numero di telefono: +33 4.67.33.73.71
- Email: b.lecardonnel@chu-montpellier.fr
Luoghi di studio
-
-
Hérault
-
Montpellier, Hérault, Francia, 34295
- Reclutamento
- CHU de Montpellier
-
Contatto:
- Agathe Roubertie, Pr.
- Numero di telefono: +33 4.67.33.01.82
- Email: a-roubertie@chu-montpellier.fr
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assessment of motor skills
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assessment of motor skills
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- de Ligt J, Willemsen MH, van Bon BW, Kleefstra T, Yntema HG, Kroes T, Vulto-van Silfhout AT, Koolen DA, de Vries P, Gilissen C, del Rosario M, Hoischen A, Scheffer H, de Vries BB, Brunner HG, Veltman JA, Vissers LE. Diagnostic exome sequencing in persons with severe intellectual disability. N Engl J Med. 2012 Nov 15;367(20):1921-9. doi: 10.1056/NEJMoa1206524. Epub 2012 Oct 3.
- Mirosevic S, Khandelwal S, Susjan P, Zakelj N, Gosar D, Forstneric V, Lainscek D, Jerala R, Osredkar D. Correlation between Phenotype and Genotype in CTNNB1 Syndrome: A Systematic Review of the Literature. Int J Mol Sci. 2022 Oct 19;23(20):12564. doi: 10.3390/ijms232012564.
- Yu X, Malenka RC. Beta-catenin is critical for dendritic morphogenesis. Nat Neurosci. 2003 Nov;6(11):1169-77. doi: 10.1038/nn1132. Epub 2003 Oct 5.
- Wang H, Zhao Y, Yang L, Han S, Qi M. Identification of a novel splice mutation in CTNNB1 gene in a Chinese family with both severe intellectual disability and serious visual defects. Neurol Sci. 2019 Aug;40(8):1701-1704. doi: 10.1007/s10072-019-03823-5. Epub 2019 Mar 30.
- Tucci V, Kleefstra T, Hardy A, Heise I, Maggi S, Willemsen MH, Hilton H, Esapa C, Simon M, Buenavista MT, McGuffin LJ, Vizor L, Dodero L, Tsaftaris S, Romero R, Nillesen WN, Vissers LE, Kempers MJ, Vulto-van Silfhout AT, Iqbal Z, Orlando M, Maccione A, Lassi G, Farisello P, Contestabile A, Tinarelli F, Nieus T, Raimondi A, Greco B, Cantatore D, Gasparini L, Berdondini L, Bifone A, Gozzi A, Wells S, Nolan PM. Dominant beta-catenin mutations cause intellectual disability with recognizable syndromic features. J Clin Invest. 2014 Apr;124(4):1468-82. doi: 10.1172/JCI70372. Epub 2014 Mar 10.
- Tang M, Miyamoto Y, Huang EJ. Multiple roles of beta-catenin in controlling the neurogenic niche for midbrain dopamine neurons. Development. 2009 Jun;136(12):2027-38. doi: 10.1242/dev.034330. Epub 2009 May 13.
- Tan WH, Bird LM, Sadhwani A, Barbieri-Welge RL, Skinner SA, Horowitz LT, Bacino CA, Noll LM, Fu C, Hundley RJ, Wink LK, Erickson CA, Barnes GN, Slavotinek A, Jeremy R, Rotenberg A, Kothare SV, Olson HE, Poduri A, Nespeca MP, Chu HC, Willen JM, Haas KF, Weeber EJ, Rufo PA. A randomized controlled trial of levodopa in patients with Angelman syndrome. Am J Med Genet A. 2018 May;176(5):1099-1107. doi: 10.1002/ajmg.a.38457. Epub 2017 Sep 25.
- Roubertie A, Roze E, Bahi-Buisson N, Payet C, Echenne B, Doummar D. [Treatment of childhood dystonia]. Arch Pediatr. 2010 May;17(5):540-53. doi: 10.1016/j.arcped.2010.02.016. Epub 2010 Apr 1. French.
- Pipo-Deveza J, Fehlings D, Chitayat D, Yoon G, Sroka H, Tein I. Rationale for dopa-responsive CTNNB1/ss-catenin deficient dystonia. Mov Disord. 2018 Apr;33(4):656-657. doi: 10.1002/mds.27320. Epub 2018 Feb 13. No abstract available.
- Nouri N, Patel MJ, Joksimovic M, Poulin JF, Anderegg A, Taketo MM, Ma YC, Awatramani R. Excessive Wnt/beta-catenin signaling promotes midbrain floor plate neurogenesis, but results in vacillating dopamine progenitors. Mol Cell Neurosci. 2015 Sep;68:131-42. doi: 10.1016/j.mcn.2015.07.002. Epub 2015 Jul 9.
- Murase S, Mosser E, Schuman EM. Depolarization drives beta-Catenin into neuronal spines promoting changes in synaptic structure and function. Neuron. 2002 Jul 3;35(1):91-105. doi: 10.1016/s0896-6273(02)00764-x.
- Liu J, Xiao Q, Xiao J, Niu C, Li Y, Zhang X, Zhou Z, Shu G, Yin G. Wnt/beta-catenin signalling: function, biological mechanisms, and therapeutic opportunities. Signal Transduct Target Ther. 2022 Jan 3;7(1):3. doi: 10.1038/s41392-021-00762-6.
- Leguire LE, Komaromy KL, Nairus TM, Rogers GL. Long-term follow-up of L-dopa treatment in children with amblyopia. J Pediatr Ophthalmol Strabismus. 2002 Nov-Dec;39(6):326-30; quiz 345-6. doi: 10.3928/0191-3913-20021101-05.
- Kuechler A, Willemsen MH, Albrecht B, Bacino CA, Bartholomew DW, van Bokhoven H, van den Boogaard MJ, Bramswig N, Buttner C, Cremer K, Czeschik JC, Engels H, van Gassen K, Graf E, van Haelst M, He W, Hogue JS, Kempers M, Koolen D, Monroe G, de Munnik S, Pastore M, Reis A, Reuter MS, Tegay DH, Veltman J, Visser G, van Hasselt P, Smeets EE, Vissers L, Wieland T, Wissink W, Yntema H, Zink AM, Strom TM, Ludecke HJ, Kleefstra T, Wieczorek D. De novo mutations in beta-catenin (CTNNB1) appear to be a frequent cause of intellectual disability: expanding the mutational and clinical spectrum. Hum Genet. 2015 Jan;134(1):97-109. doi: 10.1007/s00439-014-1498-1. Epub 2014 Oct 19.
- Koy A, Lin JP, Sanger TD, Marks WA, Mink JW, Timmermann L. Advances in management of movement disorders in children. Lancet Neurol. 2016 Jun;15(7):719-735. doi: 10.1016/S1474-4422(16)00132-0. Epub 2016 May 9.
- Kayumi S, Perez-Jurado LA, Palomares M, Rangu S, Sheppard SE, Chung WK, Kruer MC, Kharbanda M, Amor DJ, McGillivray G, Cohen JS, Garcia-Minaur S, van Eyk CL, Harper K, Jolly LA, Webber DL, Barnett CP, Santos-Simarro F, Pacio-Miguez M, Pozo AD, Bakhtiari S, Deardorff M, Dubbs HA, Izumi K, Grand K, Gray C, Mark PR, Bhoj EJ, Li D, Ortiz-Gonzalez XR, Keena B, Zackai EH, Goldberg EM, Perez de Nanclares G, Pereda A, Llano-Rivas I, Arroyo I, Fernandez-Cuesta MA, Thauvin-Robinet C, Faivre L, Garde A, Mazel B, Bruel AL, Tress ML, Brilstra E, Fine AS, Crompton KE, Stegmann APA, Sinnema M, Stevens SCJ, Nicolai J, Lesca G, Lion-Francois L, Haye D, Chatron N, Piton A, Nizon M, Cogne B, Srivastava S, Bassetti J, Muss C, Gripp KW, Procopio RA, Millan F, Morrow MM, Assaf M, Moreno-De-Luca A, Joss S, Hamilton MJ, Bertoli M, Foulds N, McKee S, MacLennan AH, Gecz J, Corbett MA. Genomic and phenotypic characterization of 404 individuals with neurodevelopmental disorders caused by CTNNB1 variants. Genet Med. 2022 Nov;24(11):2351-2366. doi: 10.1016/j.gim.2022.08.006. Epub 2022 Sep 9.
- Ho S, Tsang MH, Fung JL, Huang H, Chow CB, Cheng SS, Luk HM, Chung BH, Lo IF. CTNNB1-related neurodevelopmental disorder in a Chinese population: A case series. Am J Med Genet A. 2022 Jan;188(1):130-137. doi: 10.1002/ajmg.a.62504. Epub 2021 Sep 24.
- Garone G, Innocenti A, Grasso M, Mandarino A, Capuano A, Della Bella G, Frascarelli F, Diodato D, Onesimo R, Zampino G, Novelli A, Digilio MC, Bartuli A, Dentici ML, Parisi P, Galosi S, Tonduti D, Bertini E, Sinibaldi L, Specchio N. Movement disorder phenotype in CTNNB1-syndrome: A complex but recognizable phenomenology. Parkinsonism Relat Disord. 2024 Sep;126:107057. doi: 10.1016/j.parkreldis.2024.107057. Epub 2024 Jul 9.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RECMPL23_0426
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su L-DOPA
-
King's College LondonMedical Research CouncilCompletatoPlacebo | Aloperidolo | L-DOPARegno Unito
-
Beijing Normal UniversityYale UniversityCompletatoGruppo dell'ossitocina | Gruppo L-DOPA | Gruppo placeboCina
-
Xinhua Hospital, Shanghai Jiao Tong University...The Affiliated Hospital of Qingdao University; Shanghai University of Traditional... e altri collaboratoriSconosciutoDiscinesia indotta da L-DOPACina
Prove cliniche su L-Dopa
-
University of AlbertaAlberta Health servicesCompletatoMorbo di Parkinson | Tumori neuroendocrini | Neuroblastoma | Iperinsulinismo congenito | Glioma cerebraleCanada
-
Beta Emitting Accurate Monitored SystemsAssistance Publique - Hôpitaux de ParisReclutamentoGlioblastoma | Tumori cerebrali | Imaging cerebraleFrancia
-
National Taiwan University HospitalReclutamentoMorbo di Parkinson | Epatite B | Epatite CTaiwan
-
National Institute of Diabetes and Digestive and...Reclutamento
-
Institut Cancerologie de l'OuestCompletatoRisonanza magnetica | Metastasi cerebraliFrancia
-
National Institute of Diabetes and Digestive and...CompletatoIperparatiroidismo | Neoplasia endocrina multipla | Ipercalcemia | UOMINI1 | Neoplasia paratiroideaStati Uniti
-
Tel-Aviv Sourasky Medical CenterSconosciuto
-
Impel PharmaceuticalsCompletatoMorbo di ParkinsonAustralia
-
Children's Hospital of PhiladelphiaUniversity of PennsylvaniaCompletatoIpoglicemia iperinsulinemica persistente dell'infanzia (PHHI) | Iperinsulinismo congenito (CHI)Stati Uniti
-
Children's Hospital of PhiladelphiaUniversity of PennsylvaniaCompletatoIperinsulinismo | Iperinsulinismo congenito | Ipoglicemia iperinsulinemica persistente dell'infanzia | CHI | PHHIStati Uniti