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

Not Applicable

Recruiting

• Conditions: Drug resistance genetic epilepsy syndromes.; Generalized idiopathic epilepsy and epileptic syndromes; G40.3

• Registration Number: IRCT20110628006907N19
• Lead Sponsor: Institute for Orphan Drug Discovery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

If the patient can not swallow the tablet.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.