At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 51 enrolled
Drug / intervention
Active comparator: Modafinil + placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
In Brief
A Phase 2 clinical trial evaluating Active comparator: Modafinil + placebo, THN102 300/3, and 1 other intervention for Narcolepsy. Completed, enrolled 51 participants across 8 sites in 2 countries.
Detailed Summary
This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy
CountriesBelgium, France
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartSep 2016
Primary CompletionDec 2018
Study CompletionFeb 2019
TodayJul 2026
First PostedJul 1, 2016
Enrollment StartSep 1, 2016
Primary CompletionDec 1, 2018
Study CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.0 years ago
Interventions
Active comparator: Modafinil + placebodrug
THN102 300/3drug
THN102 300/27drug