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Efficacy of Ramelteon in pharmacoresistant patients with Dravet syndrome aged more than 6 years in the pediatric epileptic centers in seizures control

Efficacy of Ramelteon in pharmacoresistant patients with Dravet syndrome aged more than 6 years in the pediatric epileptic centers in seizures control

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220105053639N1
Enrollment
10
Registered
2022-04-19
Start date
2022-04-30
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Dravet Syndrome. Polymorphic epilepsy in infancy (PMEI)

Interventions

Intervention group: Ten patients with Dravet syndrom with Ramelteon treatment by the dose of 8 mg/day orally divided into two parts for three months.

Sponsors

Theracule AS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to No maximum

Inclusion criteria

Inclusion criteria: Minimum seizure frequency should be 6 seizures per month Minimum age should be 6 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 treatment. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Any outcome other than reducing the frequency of seizures and improving the quality of treatment (side effect) is considered a secondary consequence. 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.

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