Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05225051
Other study ID # 2021-A00407-34
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date May 1, 2023

Study information

Verified date March 2022
Source Central Hospital, Nancy, France
Contact Mathilde Renaud, MD, PhD
Phone 03 83 15 36 22
Email m.renaud2@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Descriptive analysis of N- homocysteinylated Huntingtin in 3 groups of human fibroblasts: 1. presymptomatic HD individuals with UHDRS motor ≤ 5 (Mutated Huntingtin), 2. symptomatic HD individuals with motor UHDRS > 5 (Mutated Huntingtin) 3. human control cell lines, unmutated Huntingtin


Description:

Prospective inclusions of 32 subjects with 24 symptomatic HD patients and 8 presymptomatic HD patients.Rationale: This is a pilot study in humans. Over a period of 2 years, the potential recruitment should make it possible to include 32 patients This number will make it possible to calculate the overall variability of the dosage and to have statistics of position and dispersion in the 2 subgroups identified. Controls: Eight standardized cell lines from human fibroblasts


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date May 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with the symptomatic or presymptomatic Huntington's disease gene (CAG >= 36) - Molecularly confirmed Huntington's disease - Patient 18 years of age and older - Person affiliated to or benefiting from a social security assurance Exclusion Criteria: - Person deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 - Pregnant woman, parturient or nursing mother - Women of childbearing potential who do not have effective contraception - Intellectual deterioration preventing the understanding of research

Study Design


Related Conditions & MeSH terms


Intervention

Other:
skin biopsy
skin biopsy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

References & Publications (2)

Bossenmeyer-Pourié C, Smith AD, Lehmann S, Deramecourt V, Sablonnière B, Camadro JM, Pourié G, Kerek R, Helle D, Umoret R, Guéant-Rodriguez RM, Rigau V, Gabelle A, Sequeira JM, Quadros EV, Daval JL, Guéant JL. N-homocysteinylation of tau and MAP1 is incre — View Citation

Geoffroy A, Kerek R, Pourié G, Helle D, Guéant JL, Daval JL, Bossenmeyer-Pourié C. Late Maternal Folate Supplementation Rescues from Methyl Donor Deficiency-Associated Brain Defects by Restoring Let-7 and miR-34 Pathways. Mol Neurobiol. 2017 Sep;54(7):501 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Huntingtin homocysteinylated level measures the interaction between Homocysteine and Huntingtin in fibroblasts Through study completion, an average of 2 years
Secondary Blood levels of B9, B12 Blood levels of B9, B12 Through study completion, an average of 2 years
Secondary Blood levels of homocysteinemia Blood levels of homocysteinemia Through study completion, an average of 2 years
See also
  Status Clinical Trial Phase
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Not yet recruiting NCT04429230 - Non-invasive Brain Stimulation in Huntington's Disease N/A
Recruiting NCT05032196 - Study of WVE-003 in Patients With Huntington's Disease Phase 1/Phase 2
Recruiting NCT03599076 - Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease Huntington's Disease
Terminated NCT04617860 - Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease Phase 1/Phase 2
Completed NCT05748288 - Development of the Virtual Unified Huntington's Disease Rating Scale
Not yet recruiting NCT05360082 - Comparison Between [11C]UCB-J and [18F]SynVest-1 PET in HD.
Not yet recruiting NCT04370470 - Development of Assessments for Later Stage HD
Recruiting NCT01834053 - Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea. Phase 1/Phase 2
Completed NCT01458470 - A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease Phase 2
Completed NCT01357681 - Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study) Phase 2
Completed NCT00980694 - Bioavailability of Ubiquinol in Huntington Disease Phase 1
Completed NCT00146211 - TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease Phase 3
Recruiting NCT01412125 - Study of Biomarkers That Predict the Evolution of Huntington's Disease N/A
Completed NCT00075140 - Family Health After Predictive Huntington Disease (HD) Testing Phase 3
Recruiting NCT04818060 - Preparing for Prevention of Huntington's Disease (PREVENT-HD)
Active, not recruiting NCT04698551 - NIPD on cffDNA for Triplet Repeat Diseases
Not yet recruiting NCT04301726 - Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated With HD Phase 1
Completed NCT03421327 - Genetic Risk: Whether, When, and How to Tell Adolescents
Recruiting NCT03296176 - Metabolomic Study in Huntington's Disease (METABO-HD) N/A