Epileptic Seizures Related to DrugsNCT05341713
Epileptic Seizure in Epilepsy Patients After SARS-CoV-2 Vaccination
An observational study of Epileptic Seizures Related to Drugs and SARS-CoV-2 Acute Respiratory Disease, run by Xijing Hospital at 1 site in China.
Trial summary
Background and Objectives: Seizure attack is one of adverse effects of vaccination in epileptic patients, the risk of which after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inoculation was elucidated in the present study. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Epileptic Seizures Related to Drugs, SARS-CoV-2 Acute Respiratory Disease, Vaccine Adverse Reaction
- What is being tested?
- inactive SARS-Cov-2 vaccine
- Type of treatment
- Vaccines
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Apr 2022
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We retrospectively enrolled epilepsy patients visiting outpatient clinics of the above two centers from July 2021 to December 2021, who took inactivated vaccines from Sinovac Life Sciences and Sinopharm Group (China). The study included both adults and children aged above 3 years. All the patients were diagnosed with epilepsy according to the International League Against Epilepsy (ILAE) Commission 90 days before till 21 days after the first dose of vaccine. Demographics, clinical manifestations and vaccination records were collected.
Who may be able to join
- Male or female participants
- Have a diagnosis of epilepsy by the end of the study
- Have received at least one dose of inactive SARS-Cov-2 vaccine (Sinovac Life Sciences and Sinopharm Group)
Who cannot join
- Non-epilepsy patients vaccinated with inactive SARS-Cov-2 vaccine
- Epilepsy patients administrated with non-inactive vaccine
- Unvaccinated epilepsy patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epileptic Seizure in Epilepsy Patients After First-dose Inactivated SARS-CoV-2 Vaccination: a Self-controlled Case Series Study
Background and Objectives: Seizure attack is one of adverse effects of vaccination in epileptic patients, the risk of which after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inoculation was elucidated in the present study.
Methods: A self-controlled case series study was designed to examine the association between vaccination and epileptic seizure. A total of 240 epilepsy patients were included who were vaccinated with inactive SARS-CoV-2 vaccines (Sinovac Life Sciences and Lanzhou Institute of Biological Products) and admitted to outpatient clinics from July 2021 to December 2021. Poisson analysis was performed to estimate the relative incidence rate of epileptic seizure in risk periods (day 1-7, 8-21 and 1-21 after first-dose vaccination) compared to basal level in control period.
- Conditions
- Epileptic Seizures Related to Drugs, SARS-CoV-2 Acute Respiratory Disease, Vaccine Adverse Reaction
- Being tested
- inactive SARS-Cov-2 vaccine
- Keywords
- epilepsy patient, risk of seizure, SARS-Cov-2 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inactive SARS-Cov-2 vaccineBiological
We included epilepsy patients who were vaccinated with inactive SARS-CoV-2 vaccines
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of epileptic seizures within 21 days after first-dose vaccination with inactive SARS-CoV-2 vaccine in epilepsy patients
Overall relative incidence of epileptic seizures in risk periods compared to control period.
Measured: from 90 days before until 21 days after the first dose of vaccine
Risk of epileptic seizures in epilepsy patients of different subgroups
The associations of sex, age or medication status with the relative incidence in risk periods
Measured: from 90 days before until 21 days after the first dose of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jan 2022
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Epileptic Seizures Related to DrugsStudies 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yonghong, Xijing Hospital
- Investigators
- Gengyao Hu, doctor, Principal investigator, Air Force Military Medical University, ChinaZe Chen, master, Principal investigator, Air Force Military Medical University, ChinaKejian Wu, doctor, Principal investigator, Air Force Military Medical University, ChinaYuanhang Pan, master, Principal investigator, Air Force Military Medical University, ChinaXia Li, master, Principal investigator, Xian Children's HospitalJunxiang Bao, doctor, Study director, Air Force Military Medical University, ChinaYonghong Liu, doctor, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341713
- Sponsor's protocol ID
- KY20222046-C-1
- Status last verified
- Apr 2022
- First submitted
- 16 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Frontera JA, Sabadia S, Lalchan R, Fang T, Flusty B, Millar-Vernetti P, Snyder T, Berger S, Yang D, Granger A, Morgan N, Patel P, Gutman J, Melmed K, Agarwal S, Bokhari M, Andino A, Valdes E, Omari M, Kvernland A, Lillemoe K, Chou SH, McNett M, Helbok R, Mainali S, Fink EL, Robertson C, Schober M, Suarez JI, Ziai W, Menon D, Friedman D, Friedman D, Holmes M, Huang J, Thawani S, Howard J, Abou-Fayssal N, Krieger P, Lewis A, Lord AS, Zhou T, Kahn DE, Czeisler BM, Torres J, Yaghi S, Ishida K, Scher E, de Havenon A, Placantonakis D, Liu M, Wisniewski T, Troxel AB, Balcer L, Galetta S. A Prospective Study of Neurologic Disorders in Hospitalized Patients With COVID-19 in New York City. Neurology. 2021 Jan 26;96(4):e575-e586. doi: 10.1212/WNL.0000000000010979. Epub 2020 Oct 5.
PubMed 33020166Cabezudo-Garcia P, Ciano-Petersen NL, Mena-Vazquez N, Pons-Pons G, Castro-Sanchez MV, Serrano-Castro PJ. Incidence and case fatality rate of COVID-19 in patients with active epilepsy. Neurology. 2020 Sep 8;95(10):e1417-e1425. doi: 10.1212/WNL.0000000000010033. Epub 2020 Jun 17.
PubMed 32554773Frontera JA, Tamborska AA, Doheim MF, Garcia-Azorin D, Gezegen H, Guekht A, Yusof Khan AHK, Santacatterina M, Sejvar J, Thakur KT, Westenberg E, Winkler AS, Beghi E; contributors from the Global COVID-19 Neuro Research Coalition. Neurological Events Reported after COVID-19 Vaccines: An Analysis of VAERS. Ann Neurol. 2022 Mar 2;91(6):756-71. doi: 10.1002/ana.26339. Online ahead of print.
PubMed 35233819Massoud F, Ahmad SF, Hassan AM, Alexander KJ, Al-Hashel J, Arabi M. Safety and tolerability of the novel 2019 coronavirus disease (COVID-19) vaccines among people with epilepsy (PwE): A cross-sectional study. Seizure. 2021 Nov;92:2-9. doi: 10.1016/j.seizure.2021.08.001. Epub 2021 Aug 6.
PubMed 34391030Arnheim-Dahlstrom L, Hallgren J, Weibull CE, Sparen P. Risk of presentation to hospital with epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study. BMJ. 2012 Dec 18;345:e7594. doi: 10.1136/bmj.e7594.
PubMed 23274350
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epileptic Seizure in Epilepsy Patients After First-dose Inactivated SARS-CoV-2 Vaccination: a Self-controlled Case Series Study
- ClinicalTrials.gov ID
- NCT05341713
- Acronym / sponsor ID
- KY20222046-C-1
- Conditions
- Epileptic Seizures Related to Drugs, SARS-CoV-2 Acute Respiratory Disease, Vaccine Adverse Reaction
- Keywords
- epilepsy patient, risk of seizure, SARS-Cov-2 vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 22 Apr 2022 (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.
Background and Objectives: Seizure attack is one of adverse effects of vaccination in epileptic patients, the risk of which after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inoculation was elucidated in the present study.
Methods: A self-controlled case series study was designed to examine the association between vaccination and epileptic seizure. A total of 240 epilepsy patients were included who were vaccinated with inactive SARS-CoV-2 vaccines (Sinovac Life Sciences and Lanzhou Institute of Biological Products) and admitted to outpatient clinics from July 2021 to December 2021. Poisson analysis was performed to estimate the relative incidence rate of epileptic seizure in risk periods (day 1-7, 8-21 and 1-21 after first-dose vaccination) compared to basal level in control period.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We retrospectively enrolled epilepsy patients visiting outpatient clinics of the above two centers from July 2021 to December 2021, who took inactivated vaccines from Sinovac Life Sciences and Sinopharm Group (China). The study included both adults and children aged above 3 years. All the patients were diagnosed with epilepsy according to the International League Against Epilepsy (ILAE) Commission 90 days before till 21 days after the first dose of vaccine. Demographics, clinical manifestations and vaccination records were collected.
Key inclusion criteria (3 listed)
- Male or female participants
- Have a diagnosis of epilepsy by the end of the study
- Have received at least one dose of inactive SARS-Cov-2 vaccine (Sinovac Life Sciences and Sinopharm Group)
Key exclusion criteria (3 listed)
- Non-epilepsy patients vaccinated with inactive SARS-Cov-2 vaccine
- Epilepsy patients administrated with non-inactive vaccine
- Unvaccinated epilepsy patients
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 |
|---|---|---|
| inactive SARS-Cov-2 vaccineWe included epilepsy patients who were vaccinated with inactive SARS-CoV-2 vaccines | Biological | – |
Primary outcome
Risk of epileptic seizures within 21 days after first-dose vaccination with inactive SARS-CoV-2 vaccine in epilepsy patients
Time frame: from 90 days before until 21 days after the first dose of vaccine
Overall relative incidence of epileptic seizures in risk periods compared to control period.
Risk of epileptic seizures in epilepsy patients of different subgroups
Time frame: from 90 days before until 21 days after the first dose of vaccine
The associations of sex, age or medication status with the relative incidence in risk periods
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 22 Apr 2022.
- Background: PubMed 33020166Frontera JA, Sabadia S, Lalchan R, Fang T, Flusty B, Millar-Vernetti P, Snyder T, Berger S, Yang D, Granger A, Morgan N, Patel P, Gutman J, Melmed K, Agarwal S, Bokhari M, Andino A, Valdes E, Omari M, Kvernland A, Lillemoe K, Chou SH, McNett M, Helbok R, Mainali S, Fink EL, Robertson C, Schober M, Suarez JI, Ziai W, Menon D, Friedman D, Friedman D, Holmes M, Huang J, Thawani S, Howard J, Abou-Fayssal N, Krieger P, Lewis A, Lord AS, Zhou T, Kahn DE, Czeisler BM, Torres J, Yaghi S, Ishida K, Scher E, de Havenon A, Placantonakis D, Liu M, Wisniewski T, Troxel AB, Balcer L, Galetta S. A Prospective Study of Neurologic Disorders in Hospitalized Patients With COVID-19 in New York City. Neurology. 2021 Jan 26;96(4):e575-e586. doi: 10.1212/WNL.0000000000010979. Epub 2020 Oct 5.
- Background: PubMed 32554773Cabezudo-Garcia P, Ciano-Petersen NL, Mena-Vazquez N, Pons-Pons G, Castro-Sanchez MV, Serrano-Castro PJ. Incidence and case fatality rate of COVID-19 in patients with active epilepsy. Neurology. 2020 Sep 8;95(10):e1417-e1425. doi: 10.1212/WNL.0000000000010033. Epub 2020 Jun 17.
- Background: PubMed 35233819Frontera JA, Tamborska AA, Doheim MF, Garcia-Azorin D, Gezegen H, Guekht A, Yusof Khan AHK, Santacatterina M, Sejvar J, Thakur KT, Westenberg E, Winkler AS, Beghi E; contributors from the Global COVID-19 Neuro Research Coalition. Neurological Events Reported after COVID-19 Vaccines: An Analysis of VAERS. Ann Neurol. 2022 Mar 2;91(6):756-71. doi: 10.1002/ana.26339. Online ahead of print.
- Background: PubMed 34391030Massoud F, Ahmad SF, Hassan AM, Alexander KJ, Al-Hashel J, Arabi M. Safety and tolerability of the novel 2019 coronavirus disease (COVID-19) vaccines among people with epilepsy (PwE): A cross-sectional study. Seizure. 2021 Nov;92:2-9. doi: 10.1016/j.seizure.2021.08.001. Epub 2021 Aug 6.
- Background: PubMed 23274350Arnheim-Dahlstrom L, Hallgren J, Weibull CE, Sparen P. Risk of presentation to hospital with epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study. BMJ. 2012 Dec 18;345:e7594. doi: 10.1136/bmj.e7594.
- 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.
Gengyao Hu, doctor principal investigator
Air Force Military Medical University, China
Ze Chen, master principal investigator
Air Force Military Medical University, China
Kejian Wu, doctor principal investigator
Air Force Military Medical University, China
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 Epileptic Seizures Related to Drugs and SARS-CoV-2 Acute Respiratory Disease, run by Xijing Hospital 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 3 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: finished, as of the sponsor's last update on 22 Apr 2022. 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?
Risk of epileptic seizures within 21 days after first-dose vaccination with inactive SARS-CoV-2 vaccine in epilepsy patients (time frame: from 90 days before until 21 days after the first dose of vaccine). 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?
On the ClinicalTrials.gov record for NCT05341713, which also lists 5 linked publications.
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 22 Apr 2022.