Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

Phase 2

Completed

• Conditions: Narcolepsy
• Interventions: Drug: THN102 300/3; Drug: THN102 300/27

• Registration Number: NCT02821715
• Lead Sponsor: Theranexus

Brief 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).

Detailed Description

The 3 double blind periods (2-week) follow a stabilisation period for modafinil at 300 mg/day (open, 2-week) and are followed by a one-week washout period with the same modafinil dose.

Study Timeline

• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-01
• Study Start: 2016-09
• Primary Completion: 2018-12
• Study Completion: 2019-02
• Results First Submitted: 2020-05-26
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Results First Posted: 2020-09-04
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
THN102 300/3	THN102 300/3	3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks
THN102 300/27	THN102 300/27	3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

Primary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)	14 days after the beginning of treatment period	Range 0 to 24, low score indicates good outcome

Secondary Outcome Measures

Name	Time	Method
14-item Fatigue Scale	14 days after the beginning of treatment period	Fatigue scale is a rating scale completed by the participants at each visit starting from baseline to last visit; 14 questions to be ticked off by "yes" or "No" by the patient. 0 : No fatigue 14 : worst fatigue condition
Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)	14 days after the beginning of the screening	EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits).; The EQ-5D assesses the status on the day of visit and not over the past week. It has two parts: The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present.; The second part is a 100 mm VAS (EQ-VAS). An increase in VAS indicates an improvement in health state.
Patient Global Impression of Change (PGI-C)	14 days after the beginning of treatment period	PGI-C is a scale completed by the participants starting from screening to last Last visit (all the visits).; Participants have to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.; 1 is the best score (very much improved) 7 is the worse score (very much worse)
Clinical Global Impression of Change (CGI-C) Global Impression	14 days after the end of treatment period I	CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for global impression the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy.; For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.; 1 is the best score (very much improved) 7 is the worse score (very much worse)
Beck Depression Inventory (BDI)	14 days	Beck Depression Inventory (BDI) evaluation for depressive symptoms (including suicidal thoughts). The scale is completed by the participants from baseline, to last visit (all except screening visit). The questionnaire contains 21 items. Each must be scored from 0 to 3, minimum score = 0, maximum score = 63. A high score indicates increased severity of depression.
Patient Global Impression for Severity (PGI-S) Global Score	14 days	PGI-S us a scale filled by the participant from screening to last visit (all the visits) Participants have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among the most extremely ill patient; 1 is the best score (very much improved) 7 is the worse score (very much worse)
Clinical Global Impression of Change (CGI-C) Sleepiness	14 days after the end of treatment period I	CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for sleepiness; the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy.; For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.; 1 is the best score (very much improved) 7 is the worse score (very much worse)
Clinical Global Impression of Change (CGI-C) Cataplexy	14 days after the end of treatment period I	CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for Cataplexy; the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy.; For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.; 1 is the best score (very much improved) 7 is the worse score (very much worse)
Clinical Global Impression for Severity (CGI-S) Global Score	14 days after the end of treatment period I	CGI-S is a scale completed by the investigator at each visit : Item global impression; CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 normal-not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among hte most extremely ill patient; 1 is the best score (very much improved) 7 is the worse score (very much worse); CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy
Clinical Global Impression for Severity (CGI-S) Sleepiness	14 days after the end of treatment period I	CGI-S is a scale completed by the investigator at each visit for Sleepiness; CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 Borderline ill/ 3 Mildly ill/ 4 Moderately ill/ 5 Markedly ill/ 6 severely ill/ 7 Among the most extremely ill patient; 1 is the best score (very much improved) 7 is the worse score (very much worse); CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy
Clinical Global Impression for Severity (CGI-S) Cataplexy	14 days after the end of treatment period I	CGI-S is a scale completed by the investigator at each visit for Cataplexy; CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 Borderline ill/ 3 Mildly ill/ 4 Moderately ill/ 5 Markedly ill/ 6 severely ill/ 7 Among the most extremely ill patient; 1 is the best score (very much improved) 7 is the worse score (very much worse); CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy
EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)	14 days	EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits).; The EQ-5D is a questionnaire assessing the quality of life of the patient. It has two parts: The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present.; The second part is a 100 mm Visual analogic scale (EQ-VAS). An higher score in VAS indicates a better health state.; The questionnaire is assessed at baseline and all subsequent visits

Trial Locations

Locations (8)

CHU Pellegrin; 🇫🇷 Bordeaux, France

RespiSom; 🇧🇪 Erpent, Belgium

CHU Dijon Bourgogne; 🇫🇷 Dijon, France

Hôpital Raymond Poincaré; 🇫🇷 Garches, France

CHU Grenoble Alpes; 🇫🇷 Grenoble, France

CHRU Lilles; 🇫🇷 Lille, France

University Hospital; 🇫🇷 Montpellier, France

Groupe Hospitalier Pitié Salpêtrière; 🇫🇷 Paris, France