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Efficacy and safety of interleukin-6 receptor antagonist in the chronic phase of febrile infection-associated epilepsy syndrome (FIRES) in children: a prospective cohort study

Efficacy and safety of interleukin-6 receptor antagonist in the chronic phase of febrile infection-associated epilepsy syndrome (FIRES) in children: a prospective cohort study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085185
Enrollment
Unknown
Registered
2024-06-03
Start date
2024-06-10
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

febrile infection-related epilepsy syndrome

Interventions

Grouping based on whether to use Tocilizumab:None

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: (1) Age of onset =18 years old; (2) Consistent with a diagnosis of FIRES and already in chronic phase: all of the following conditions (a~c) were met, supported by condition (d) : a, as per the consensus on FIRES at the 6th Symposium on Status Epileptic and Acute Seizures. Previous health, growth and development with normal age children; b. Onset of seizures within 24 hours to 2 weeks after acute fever, with rapid deterioration and RSE; c. There is no clear evidence of infection, metabolic, immune and other related neurological diseases; d. Intractable epilepsy occurs immediately after the acute phase. The chronic phase was defined as 3 months / 90 days after the onset of seizures. (3) Tocilizumab was used for chronic treatment; (4) There was no limitation on whether tocilizumab was used in the acute stage, and no treatment with tocilizumab or anabucin was used in the chronic stage, and it was at least 1 month from the second tocilizumab or anabucin at the end of the acute stage; (5) The disease course of FIRES was less than 2 years. (6) The presence of relatively frequent seizures: the average frequency of seizures within 3 months before tozzizumab treatment was =3 times/month, and the continuous seizureless interval within 3 months before enrollment was =1 month; (7) No new immunotherapy was added within 1 month before enrollment, including glucocorticoid, propyl globule, rituximab, morpheolate, etc.; If other immunotherapy is combined with the above mentioned immunotherapy at the time of enrollment, it should be clear that the immunotherapy is in the process of gradual reduction at the time of enrollment or the dose of the immunotherapy drug has not been increased within 1 month before enrollment; (8) Patients voluntarily enrolled in the study.

Exclusion criteria

Exclusion criteria: (1) Abnormal liver function (ALT=3 times the upper limit of normal); (2) Neutropenia (neutrophil count <1.0×109/L); (3) Thrombocytopenia (platelet count <100×109/L); (4) There are active infections: there are active infections of the respiratory system, urinary system, digestive system, including active tuberculosis, hepatitis virus infection, other viruses or bacteria and other pathogenic infections.

Design outcomes

Primary

MeasureTime frame
Effective rate of reducing seizures after treatment with Tocilizumab;

Secondary

MeasureTime frame
adverse reaction;Effective rate of reducing seizures after treatment with Tocilizumab;Improvement rate of functional disability after treatment;The improvement rate of quality of life after treatment;Rate of improvement in development after treatment;Electroencephalogram period after treatment;

Countries

China

Contacts

Public ContactWu Ye

Peking University First Hospital, Department of Pediatric Neurology, Children's Medical Center

dryewu@263.net+86 135 2075 6697

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026