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CompletedNCT04965571Updated Jul 16, 2021

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

An observational study in Wilson Disease and Generalized Epilepsy, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2021-07-16.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
13
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Hepatolenticular Degeneration with a site in China — 10 open to participants now, 11 under way, 1 of them phase 3. Hepatolenticular Degeneration · China.

Started
2010
the only one that year
Observational
6 of 15
4 open now
Registered
5th of 15
by date
Lead sponsor
3 of 15
Second Affiliated Hospital, School of Medicine, Zhejiang University

Among the 15 studies in Hepatolenticular Degeneration with a site in China, this one is the only one that started in 2010, is one of 6 observational ones, and was the 5th registered.

Hepatolenticular Degeneration

80 studies on the registry are indexed under Hepatolenticular Degeneration; 31 are open to participants now.

Browse Hepatolenticular Degeneration studies →

Open to participants now

10 of the 15 studies in Hepatolenticular Degeneration with a site in China are open now. Recruiting first, the newest first:

5 more — sign in →

All 10 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 21 Hepatolenticular Degeneration studies recruiting now, 16 (76%) set no upper age limit and 4 (19%) stop at 75 or younger; 14 take children under 18; 3 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed 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.

03

Conditions studied

  • Wilson Disease
  • Generalized Epilepsy

Keywords

  • Chinese
  • clinical features
  • generalized epilepsy
  • outcome
  • Wilson's disease
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Each patient was diagnosed with WD by clinical evaluation and genetic screening and had ever experienced generalized epilepsy

Exclusion criteria

Exclusion Criteria:

  • Not WD \& without generalized epilepsy
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
13 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • WD-seizures

    Chinese WD patients with generalized epilepsy

    Genetic: genetic test

Interventions

  • Geneticgenetic test

    Sanger sequencing and multiplex ligation-dependent probe amplification (MLPA)

06

What researchers measure

Primary outcomes

  1. Number of participants with treatment stop seizures attacks

    After standard treatment, the patients would stop attacks and get improved.

    Time frame: 12 month

Secondary outcomes

  1. Number of participants with treatment have improved brain MRI

    After standard treatment, the abnormalities of brain MRI would get better in patients.

    Time frame: 12 month

07

Study locations

1 site
  • Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2010 to primary completion in Sep 2017, 84 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2021
First posted
Jul 16, 2021
StartActual
Sep 1, 2010
Primary completionActual
Sep 1, 2017
CompletionActual
Mar 1, 2019
Last update
Jul 16, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04965571
Responsible party
Sponsor
First posted
Jul 16, 2021
Start date
Sep 1, 2010
Primary completion
Sep 1, 2017
Completion
Mar 1, 2019
Last update
Jul 16, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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