se of melatonin and sleep deprvation in Children for EEG recordings.

Phase 1

• Conditions: suspected epilepsy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2016-000606-11-SE
• Lead Sponsor: Region Ostergotland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-19
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Children 2 to 17 years of age sent to EEG examination during sleep
because of suspected epilepsy.
Written consent of participation in the study given by parents and
children from 8 years of age.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Difficulties understanding swedish by children and/or parents.
2. Severe mental redardation of the child.
3. Known or suspected allergy to melatonin.
4. Liver or kidney falure;
5.Ongoing medication with kinolones, fluvoxamin, 5-och 8-metoxipsoralen, cimetidin, or oestrogenes.
6. Pregnancy or breast-feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified