Clinical trial • Phase II • Endocrinology

Melatonin for Primary insomnia

Phase II trial of Melatonin for Primary insomnia. Circadin (reference) vs Melatonin PILEJE LP 2 mg (test); dose 2 mg; schedule not specified-controlled.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Primary insomnia
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-06-2025
First CTIS Authorization Date
28-08-2025

Trial design

Circadin (reference) vs Melatonin PILEJE LP 2 mg (test); dose 2 mg; schedule not specified-controlled Phase II trial across 1 site in France.

Comparator
Circadin (reference) vs Melatonin PILEJE LP 2 mg (test); dose 2 mg; schedule not specified
Target Sample Size
24

Eligibility

Recruits 24 No vulnerable population selected. Participants are healthy volunteers. No assent or special consent procedures reported in the record..

Vulnerable Population
No vulnerable population selected. Participants are healthy volunteers. No assent or special consent procedures reported in the record.

Recruitment

Planned Sample Size
24
Recruitment Window Months
6

Geography

Total Number Of Sites
1
Total Number Of Participants
24

France

Earliest CTIS Part Ii Submission Date
31-07-2025
Latest Decision Or Authorization Date
28-08-2025
Processing Time Days
28
Number Of Sites
1
Number Of Participants
24

Sites

Site Name
Eurofins Optimed
Department Name
clinical pharmacology unit
Contact Person Name
Lila KREBS-DROUOT

Sponsor

Primary sponsor

Full Name
Pileje
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Investigational products

Investigational Product Name
Melatonin PILEJE LP 2 mg; Circadin (reference)
Active Substance
Melatonin
Modality
Small molecule
Starting Dose
2 mg
Dose Levels
2 mg

Related trials

Other published trials that may interest you.