Wilson DiseaseNCT04965571
Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients
An observational study of Wilson Disease and Generalized Epilepsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wilson Disease, Generalized Epilepsy
- What is being tested?
- genetic test
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2010to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Each patient was diagnosed with WD by clinical evaluation and genetic screening and had ever experienced generalized epilepsy
Who cannot join
- Not WD \& without generalized epilepsy
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
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.
- Conditions
- Wilson Disease, Generalized Epilepsy
- Being tested
- genetic test
- Keywords
- Chinese, clinical features, generalized epilepsy, outcome, Wilson's disease
- Medical subject headings
- Hepatolenticular Degeneration, Epilepsy, Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic testGenetic
Sanger sequencing and multiplex ligation-dependent probe amplification (MLPA)
| Study group | Role | What they receive |
|---|---|---|
| WD-seizures | Chinese WD patients with generalized epilepsy Receives: Genetic: genetic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment stop seizures attacks
After standard treatment, the patients would stop attacks and get improved.
Measured: 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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Sep 2010
- Primary completion1 Sep 2017
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilson DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965571
- Sponsor's protocol ID
- WD-seizures
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients
- ClinicalTrials.gov ID
- NCT04965571
- Acronym / sponsor ID
- WD-seizures
- Conditions
- Wilson Disease, Generalized Epilepsy
- Keywords
- Chinese, clinical features, generalized epilepsy, outcome, Wilson's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WD-seizures | – | Genetic: genetic testChinese WD patients with generalized epilepsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Each patient was diagnosed with WD by clinical evaluation and genetic screening and had ever experienced generalized epilepsy
Key exclusion criteria (1 listed)
- Not WD \& without generalized epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic testSanger sequencing and multiplex ligation-dependent probe amplification (MLPA) | Genetic | WD-seizures |
Primary outcome
Number of participants with treatment stop seizures attacks
Time frame: 12 month
After standard treatment, the patients would stop attacks and get improved.
1 secondary outcome
Number of participants with treatment have improved brain MRI
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilson Disease and Generalized Epilepsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment stop seizures attacks (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.