Clinical trial • Phase IV • Neurology|Rare Disease

Solriamfetol for Idiopathic hypersomnia

Phase IV trial of Solriamfetol for Idiopathic hypersomnia. Randomised, placebo (dose and schedule not specified)-controlled. 60 participants.

Overview

Trial Therapeutic Area
Neurology|Rare Disease
Trial Disease
Idiopathic hypersomnia
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
05-04-2024
First CTIS Authorization Date
11-07-2024

Trial design

Randomised, placebo (dose and schedule not specified)-controlled Phase IV trial across 1 site in France.

Randomised
Yes
Comparator
Placebo (dose and schedule not specified)
Target Sample Size
60

Eligibility

Recruits 60 No vulnerable populations selected..

Vulnerable Population
No vulnerable populations selected.

Recruitment

Planned Sample Size
60
Recruitment Window Months
29

Geography

Total Number Of Sites
1
Total Number Of Participants
60

France

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
07-08-2025
Processing Time Days
416
Number Of Sites
1
Number Of Participants
60

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Neurologie
Principal Investigator Name
Yves DAUVILLIERS
Principal Investigator Email
y-dauvilliers@chu-montpellier.fr
Contact Person Name
Yves DAUVILLIERS

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Montpellier
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Solriamfetol
Active Substance
Solriamfetol
Modality
Small molecule

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