The Effect of Everolimus in the Treatment of Tuberous Sclerosis Complex

The Effect of Everolimus on Renal, Brain, Skin Lesions and Seizure of Tuberous Sclerosis Complex

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20131012014988N2

Enrollment

Registered

2017-12-05

Start date

2017-07-04

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Tuberous sclerosis. Other congenital malformations

Interventions

In the case (intervention) group, based on the scientific references, 3 mg/m2/day "Everolimus" (C53H83NO14), in 5 mg tablet form (Novartis Co, Swiss), will administer for 6 months..

Treatment - Drugs

In the case (intervention) group, based on the scientific references, 3 mg/m2/day "Everolimus" (C53H83NO14), in 5 mg tablet form (Novartis Co, Swiss), will administer for 6 months.

Eligibility

Sex/Gender

All

Age

No minimum to 15 Years

Inclusion criteria

Inclusion criteria: 20 children, age under 15 years, with TSC proven by an expert physician through clinical and paraclinical criteria will include in this study Parental consent of the patients

Exclusion criteria

Exclusion criteria: Having any underlying disease Drug prohibition

Design outcomes

Secondary

Measure	Time frame
Constipation. Timepoint: During the six months of the administration period. Method of measurement: Clinical Examination, Questionnaire.;Nausea. Timepoint: During the six months of the administration period. Method of measurement: Clinical Examination, Questionnaire.;Diarrhea. Timepoint: During the six months of the administration period. Method of measurement: Clinical Examination, Questionnaire.;Vomiting. Timepoint: During the six months of the administration period. Method of measurement: Clinical Examination, Questionnaire.;Body weight. Timepoint: During the six months of the administration period. Method of measurement: Scale, Questionnaire.	—

Measure

Time frame

Constipation. Timepoint: During the six months of the administration period. Method of measurement: Clinical Examination, Questionnaire.;Nausea. Timepoint: During the six months of the administration period. Method of measurement: Clinical Examination, Questionnaire.;Diarrhea. Timepoint: During the six months of the administration period. Method of measurement: Clinical Examination, Questionnaire.;Vomiting. Timepoint: During the six months of the administration period. Method of measurement: Clinical Examination, Questionnaire.;Body weight. Timepoint: During the six months of the administration period. Method of measurement: Scale, Questionnaire.

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Primary

Measure	Time frame
Renal lesions severity. Timepoint: before treatment-six months after the treatment. Method of measurement: MRI, Medical ultrasound (sonography), questionnaire.;Brain lesions severity. Timepoint: before treatment-six months after the treatment. Method of measurement: MRI, Medical ultrasound (sonography), questionnaire.;Skin lesions severity. Timepoint: before treatment-six months after the treatment. Method of measurement: Medical examination, questionnaire.;Seizure. Timepoint: before treatment-six months after the treatment. Method of measurement: Questionnaire.	—

Measure

Time frame

Renal lesions severity. Timepoint: before treatment-six months after the treatment. Method of measurement: MRI, Medical ultrasound (sonography), questionnaire.;Brain lesions severity. Timepoint: before treatment-six months after the treatment. Method of measurement: MRI, Medical ultrasound (sonography), questionnaire.;Skin lesions severity. Timepoint: before treatment-six months after the treatment. Method of measurement: Medical examination, questionnaire.;Seizure. Timepoint: before treatment-six months after the treatment. Method of measurement: Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Barzegar

Pediatric Health Research Center, Tabriz University of Medical Sciences

phrc_mb@tbzmed.ac.ir+98 41 3526 2265

Outcome results

None listed

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