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NCT05341713
Epileptic Seizure in Epilepsy Patients After SARS-CoV-2 Vaccination
trial testing inactive SARS-Cov-2 vaccine in Epileptic Seizures Related to Drugs in 240 participants. Completed in 1 April 2022.
1 April 2022
Quick facts
| Lead sponsor | Xijing Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 240 |
| Start date | 1 January 2022 |
| Primary completion | 1 April 2022 |
| Estimated completion | 1 April 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- inactive SARS-Cov-2 vaccine — full drug profile →
Conditions studied
- Epileptic Seizures Related to Drugs — all drugs for Epileptic Seizures Related to Drugs →
- SARS-CoV-2 Acute Respiratory Disease — all drugs for SARS-CoV-2 Acute Respiratory Disease →
- Vaccine Adverse Reaction — all drugs for Vaccine Adverse Reaction →
Sponsor
Xijing Hospital
Who can join
3 and older, any sex, with Epileptic Seizures Related to Drugs or SARS-CoV-2 Acute Respiratory Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05341713
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05341713 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital
- Last refreshed: 22 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05341713.
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