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NCT04965571 Clinical Trial

Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients

Wilson Disease Clinical Trial

Official title:
Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04965571
Other study ID # WD-seizures
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2010
Est. completion date March 1, 2019

Study information
Verified date July 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Generalized epilepsy is rarely reported in patients with Wilson disease (WD) and lacks experience in clinical practice. We aim to provide better experience for the diagnosis and treatment for WD patients with epilepsy in the future.

Description:

A retrospective study was performed in 13 Chinese WD patients with generalized epilepsy. Each patient was diagnosed with WD by clinical evaluation and genetic screening. Patients were given small doses of antiepileptic drugs (AEDs), followed by copper-chelation therapy when the seizures stabilized. Clinical manifestations, brain imaging changes, and treatment and outcome after a long-term follow-up were analyzed.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date March 1, 2019
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Each patient was diagnosed with WD by clinical evaluation and genetic screening and had ever experienced generalized epilepsy Exclusion Criteria: - Not WD & without generalized epilepsy

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• genetic test
Sanger sequencing and multiplex ligation-dependent probe amplification (MLPA)

Locations
Country Name City State
China Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with treatment stop seizures attacks After standard treatment, the patients would stop attacks and get improved. 12 month
Secondary Number of participants with treatment have improved brain MRI After standard treatment, the abnormalities of brain MRI would get better in patients. 12 month
See also
  Status Clinical Trial Phase
Completed NCT04573309 - Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840 Phase 2
Completed NCT03539952 - Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease Phase 3
Active, not recruiting NCT04884815 - Study of UX701 Gene Transfer for the Treatment of Wilson Disease Phase 1/Phase 2
Not yet recruiting NCT03659331 - A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease N/A
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Terminated NCT05047523 - Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease Phase 3
Completed NCT04526210 - Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants Phase 1
Completed NCT00004338 - Study of Zinc for Wilson Disease Phase 4
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Completed NCT02273596 - Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients Phase 2
Completed NCT02763215 - The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment
Recruiting NCT05444127 - Oral Health and Wilson's Disease: SOMAWI
Completed NCT04408300 - Study of Retinal Vascular Parameters in Patients With Wilson's Disease N/A
Recruiting NCT05783687 - Real World Evidence Study in Subjects With Wilson's Disease
Terminated NCT04909346 - Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease
Completed NCT03867526 - Establishment of Human Cellular Disease Models for Wilson Disease
Enrolling by invitation NCT03589820 - Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure N/A
Completed NCT04526197 - Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants. Phase 1
Completed NCT04910581 - rTMS in Wilson Disease Dysarthria N/A
Active, not recruiting NCT02426905 - Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine Phase 4