Everolimus in sub ependymal giant cell astrocytoma

Efficacy of Everolimus in pediatric patients with tuberous sclerosis and sub ependymal giant cell astrocytoma

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240112060688N1

Enrollment

Registered

2024-12-23

Start date

2024-12-21

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

tuberous sclerosis. Tuberous sclerosis

Interventions

Intervention group: eligible children (aged under ?? years old) with a definite diagnosis of tuberous sclerosis complex will be included by convenience sampling method based on the inclusion exclusion

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patients who definitely diagnosed by tuberous sclerosis complex and medically stable children 1 to 18 years old

Exclusion criteria

Exclusion criteria: To require any surgery for subependymal giant cell astrocytomas, critical hydrocephalus or imminent cerebral herniation

Design outcomes

Primary

Measure	Time frame
Decreased size of sub ependymal giant cell astrocytoma. Timepoint: at the beginning and every 3 months till one year. Method of measurement: MRI findings.;Absolute change from baseline to ?? weeks in seizure frequency per ?? hours. Timepoint: at the beginning and every 3 months till one year. Method of measurement: Electroencephalography.;Skin lesion response rate in patients with at least one skin lesion at baseline;. Timepoint: at the beginning and every 3 months till one year. Method of measurement: physical examination.;Angiomyolipoma response rate. Timepoint: at the beginning and every 3 months till one year. Method of measurement: ultrasound sonography.	—

Measure

Time frame

Decreased size of sub ependymal giant cell astrocytoma. Timepoint: at the beginning and every 3 months till one year. Method of measurement: MRI findings.;Absolute change from baseline to ?? weeks in seizure frequency per ?? hours. Timepoint: at the beginning and every 3 months till one year. Method of measurement: Electroencephalography.;Skin lesion response rate in patients with at least one skin lesion at baseline;. Timepoint: at the beginning and every 3 months till one year. Method of measurement: physical examination.;Angiomyolipoma response rate. Timepoint: at the beginning and every 3 months till one year. Method of measurement: ultrasound sonography.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Mottaghipisheh

Shiraz University of Medical Sciences

hmottaghipisheh@gmail.com+98 71 3632 3534

Outcome results

None listed

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