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Efficacy of Rameleteon in pediatrics and adolescent patients aged more than 5 years with drug resistancegenetic epilepsy syndromes

Efficacy of Rameleteon in pediatrics and adolescent patients aged more than 5 years with drug resistancegenetic epilepsy syndromes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110628006907N19
Enrollment
20
Registered
2023-12-01
Start date
2024-01-05
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Drug resistance genetic epilepsy syndromes. Generalized idiopathic epilepsy and epileptic syndromes

Interventions

Intervention group: Twenty patients with drug resistance genetic epilepsy syndromes with Ramelteon treatment by the dose of 1 and 8 mg/day orally divided into four parts for three months.

Sponsors

Institute for Orphan Drug Discovery
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to No maximum

Inclusion criteria

Inclusion criteria: Minimum seizure frequency should be 20 seizures per month Minimum age should be 5 years old

Exclusion criteria

Exclusion criteria: If the patient can not swallow the tablet.

Design outcomes

Primary

MeasureTime frame
Seizure frequency. Timepoint: Measurement of seizure frequency one month before the study (before the intervention) and 1, 2 and 3 months after the start of Remeltion. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Decreased quality of life caused by treatment. Timepoint: Measuring the quality of life one month before the study (before the start of the intervention) and 1, 2 and 3 months after the start of Rameltion. Method of measurement: Questionnaire.;Emergence of new types of seizures in patients. Timepoint: Measuring the quality of life one month before the study (before the start of the intervention) and 1, 2 and 3 months after the start of Rameltion. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSareh Hosseinpour

Tehran University of Medical Sciences

hosseinpour.sare@gmail.com+98 21 6693 0024

Outcome results

None listed

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