A prospective cohort study of epileptic seizures in patients with focal cortical dysplasia type II

Not Applicable

• Conditions: Epilepsy with focal cortical dysplasia type II

• Registration Number: JPRN-UMIN000033606
• Lead Sponsor: Research group on rare epilepsy

Brief Summary

The focal seizure frequency reduced by 0.5%.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study Completion: 2020-09-30
• Results First Posted: 2021-12-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Those scheduled to participate in a single-group, open-label study of sirolimus against FCDII type. (2) Those having orally ingested sirolimus or everolimus within 52 weeks before the start of the baseline observation period. (3) In case neither the patient nor the substitute cannot accurately record the number and timing of epileptic seizures. (4) Those with suspected progressive brain lesion in head computed tomography (CT) or magnetic resonance imaging (MRI). (5) Those who underwent surgical treatment for epilepsy (focal resection surgery, multiple subpial transection, functional hemispherotomy, corpus callosotomy, VNS implantation, or electrodes implantation) within 28 weeks before the baseline observation period. (6) Those with a history of suicide attempts. (7) Those with a history or complication of substance abuse (including alcohol abuse). (8) Those who underwent surgical operation (surgery requiring invasion into the body cavity or surgery requiring suture of three or more needles, including biopsy) within 12 weeks before baseline observation period. (9) Those judged inappropriate as a subject of this study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction rate from the baseline of the frequency of partial seizures (including secondarily generalized seizures) per 28 days after 6 months

Secondary Outcome Measures

Name	Time	Method
-Change from the baseline of the frequency of general seizures per 28 days after 6 months -Change from the baseline of the frequency of epileptic spasms per 28 days after 6 months -Change from the baseline of the frequency of status epilepticus per 28 days after 6 months -Distribution of demographics -Status of surgical and/or medical treatment