EpilepsyNCT04516590
The Diagnostic Value of Autoimmune Antibody Detection in Newly Onset and Chronic Epilepsy
An observational study of Epilepsy, run by Xijing Hospital.
Trial summary
multi-central and prospectively study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy, and provide reference for clinical practice Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Sep 2021
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with newly onset or chronic epilepsy
Who may be able to join
- Patients diagnosed with epilepsy according to the diagnostic criteria of International League Against Epilepsy (ILAE) 2017
- Age from 16 to 70 years old
- The etiology of patients with epilepsy is unknown
- The patient or guardian signs an informed consent and can cooperate with the inspection and follow-up for six months
Who cannot join
- Patients with hereditary, infectious, and metabolic epilepsy
- The investigation and follow-up cannot be completed due to vision, hearing, language expression, disturbance of consciousness, and impaired understanding, and the guardian cannot replace the completed
- Patients with other progressive or systemic diseases
About this study
multi-central and prospectively study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy, and provide reference for clinical practice
Read the detailed description
multi-centrally recruit patients with newly onset or chronic epilepsy and hoping to find whether there exist an autoimmune cause. whether the patients receive immune therapy or not will depend on the type and titter of the autoimmune antibody as well as the severity of the symptom. At 3 and 6 months later, all patients will be followed-up, and the positive autoimmune antibody will be redetected. the clinical manifest, clinical data, medication and treatment outcome will be recorded and analyzed, to study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy
- Conditions
- Epilepsy
- Keywords
- epilepsy, autoimmune antibody, diagnose
- Medical subject headings
- Epilepsy, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
There was no intervention in this observational study
| Study group | Role | What they receive |
|---|---|---|
| autoimmune antigen negative | treated with anti-epilepsy drugs | |
| autoimmune antigen positive | whether the patients receive immune therapy or not will depend on the type and titter of the autoimmune antibody as well as the severity of the symptom |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the seizure frequency
Seizure frequency are described as no seizures, less than one per month, monthly, weekly, and daily. the change of seizure frequency include 'increased', 'decreased', and 'no change' compared to the frequency before they were enrolled
Measured: at six months after the patients being enrolled
change of the autoimmune antigen
autoimmune antigen in the serum of patients was described as positive and negative. the change of the autoimmune antigen include 'turn negative' and 'still positive' compared to the first detection.
Measured: at six months after the patients being enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital of Ningxia Medical University, LanZhou University, First Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, First Affiliated Hospital of Zhejiang University, Wulumuqi General Hospital of Lanzhou Military Command, Xuanwu Hospital, Beijing, Xiangya Hospital of Central South University, West China Hospital, Affiliated Hospital of Qinghai University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516590
- Sponsor's protocol ID
- XijingH Deng Yanchun-1
- Status last verified
- Aug 2020
- First submitted
- 30 Jun 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Autoimmune Antibody Detection in Newly Onset and Chronic Epilepsy
- ClinicalTrials.gov ID
- NCT04516590
- Acronym / sponsor ID
- XijingH Deng Yanchun-1
- Conditions
- Epilepsy
- Keywords
- epilepsy, autoimmune antibody, diagnose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- General Hospital of Ningxia Medical University, LanZhou University, First Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, First Affiliated Hospital of Zhejiang University, Wulumuqi General Hospital of Lanzhou Military Command, Xuanwu Hospital, Beijing, Xiangya Hospital of Central South University, West China Hospital, Affiliated Hospital of Qinghai University
- Study start
- Aug 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 Aug 2020 (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.
multi-central and prospectively study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy, and provide reference for clinical practice
Detailed description
multi-centrally recruit patients with newly onset or chronic epilepsy and hoping to find whether there exist an autoimmune cause. whether the patients receive immune therapy or not will depend on the type and titter of the autoimmune antibody as well as the severity of the symptom. At 3 and 6 months later, all patients will be followed-up, and the positive autoimmune antibody will be redetected. the clinical manifest, clinical data, medication and treatment outcome will be recorded and analyzed, to study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autoimmune antigen negative | – | –treated with anti-epilepsy drugs |
| autoimmune antigen positive | – | –whether the patients receive immune therapy or not will depend on the type and titter of the autoimmune antibody as well as the severity of the symptom |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with newly onset or chronic epilepsy
Key inclusion criteria (4 listed)
- Patients diagnosed with epilepsy according to the diagnostic criteria of International League Against Epilepsy (ILAE) 2017
- Age from 16 to 70 years old
- The etiology of patients with epilepsy is unknown
- The patient or guardian signs an informed consent and can cooperate with the inspection and follow-up for six months
Key exclusion criteria (3 listed)
- Patients with hereditary, infectious, and metabolic epilepsy
- The investigation and follow-up cannot be completed due to vision, hearing, language expression, disturbance of consciousness, and impaired understanding, and the guardian cannot replace the completed
- Patients with other progressive or systemic diseases
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 |
|---|---|---|
| There was no intervention in this observational study | Other | autoimmune antigen negative, autoimmune antigen positive |
Primary outcome
change of the seizure frequency
Time frame: at six months after the patients being enrolled
Seizure frequency are described as no seizures, less than one per month, monthly, weekly, and daily. the change of seizure frequency include 'increased', 'decreased', and 'no change' compared to the frequency before they were enrolled
change of the autoimmune antigen
Time frame: at six months after the patients being enrolled
autoimmune antigen in the serum of patients was described as positive and negative. the change of the autoimmune antigen include 'turn negative' and 'still positive' compared to the first detection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Xijing Hospital.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
change of the seizure frequency (time frame: at six months after the patients being enrolled). The study lists 2 primary outcomes in all. 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 18 Aug 2020.