Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

Theranexus51 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Narcolepsy

Interventions

Active comparator: Modafinil + placeboDRUG

THN102 300/3DRUG

THN102 300/27DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Main inclusion Criteria: * Patients with a diagnosis of narcolepsy type 1 (i.e. with cataplexy) or type 2 (without cataplexy) according to the International Classification of Sleep Disorders (ICSD-3) criteria. * Body mass index \>18 kg/m2 and \<35 kg/m2. * Patients treated with modafinil at stable dosage for at least 2 months and still complaining of excessive daily somnolence (EDS) despite the treatment * Epworth Sleepiness Scale (ESS) score should be ≥ 14/24 during the baseline period. Main exclusion Criteria: * Patients with an untreated sleep apnea syndrome (respiratory disorder index \> 30/h) or who have any other cause of daytime sleepiness as assessed on patient history. * Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as Parkinson's disease, Alzheimer's disease, Huntington's Chorea, multiple sclerosis, moderate or severe psychosis or dementia, bipolar illness, epilepsy, severe clinical anxiety or depression, Beck Depression Inventory ≥ 21 or with suicidal risk (if item \> 0), or other problem that in the investigator's opinion would preclude the patient's participation and completion of this trial or comprise reliable representation of subjective symptoms. * Contraindication to flecainide

Locations (8)

RespiSom

Erpent, Belgium

CHU Pellegrin

Bordeaux, France

CHU Dijon Bourgogne

Dijon, France

Hôpital Raymond Poincaré

Garches, France

Outcomes

Primary Outcomes

Epworth Sleepiness Scale (ESS)

Range 0 to 24, low score indicates good outcome

Time frame: 14 days after the beginning of treatment period

Secondary Outcomes

14-item Fatigue Scale

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

Time frame: 14 days after the beginning of treatment period

Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)

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.

Time frame: 14 days after the beginning of the screening

Patient Global Impression of Change (PGI-C)

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)

Time frame: 14 days after the beginning of treatment period

Clinical Global Impression of Change (CGI-C) Global Impression

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)

Data from ClinicalTrials.gov

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CHU Grenoble Alpes

Grenoble, France

CHRU Lilles

Lille, France

University Hospital

Montpellier, France

Groupe Hospitalier Pitié Salpêtrière

Paris, France

Time frame: 14 days after the end of treatment period I

Beck Depression Inventory (BDI)

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.

Time frame: 14 days

Patient Global Impression for Severity (PGI-S) Global Score

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)

Time frame: 14 days

Clinical Global Impression of Change (CGI-C) Sleepiness

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)

Time frame: 14 days after the end of treatment period I

Clinical Global Impression of Change (CGI-C) Cataplexy

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)

Time frame: 14 days after the end of treatment period I

Clinical Global Impression for Severity (CGI-S) Global Score

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

Time frame: 14 days after the end of treatment period I

Clinical Global Impression for Severity (CGI-S) Sleepiness

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

Time frame: 14 days after the end of treatment period I

Clinical Global Impression for Severity (CGI-S) Cataplexy

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

Time frame: 14 days after the end of treatment period I

EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)

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

Time frame: 14 days