Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
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ClinicalTrials.gov Identifier: NCT02821715 |
Recruitment Status :
Completed
First Posted : July 1, 2016
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
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Condition or disease | Intervention/treatment | Phase |
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Narcolepsy | Drug: Active comparator: Modafinil + placebo Drug: THN102 300/3 Drug: THN102 300/27 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients |
Study Start Date : | September 2016 |
Actual Primary Completion Date : | December 2018 |
Actual Study Completion Date : | February 2019 |

Arm | Intervention/treatment |
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Active Comparator: Modafinil + placebo
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
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Drug: Active comparator: Modafinil + placebo
Other Names:
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Experimental: 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
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Drug: THN102 300/3
Other Names:
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Experimental: 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
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Drug: THN102 300/27
Other Names:
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- Epworth Sleepiness Scale (ESS) [ Time Frame: 14 days after the beginning of treatment period ]Range 0 to 24, low score indicates good outcome
- 14-item Fatigue Scale [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821715
Belgium | |
RespiSom | |
Erpent, Belgium | |
France | |
CHU Pellegrin | |
Bordeaux, France, 33076 | |
CHU Dijon Bourgogne | |
Dijon, France | |
Hôpital Raymond Poincaré | |
Garches, France, 92380 | |
CHU Grenoble Alpes | |
Grenoble, France | |
CHRU Lilles | |
Lille, France, 59037 | |
University Hospital | |
Montpellier, France, 34090 | |
Groupe Hospitalier Pitié Salpêtrière | |
Paris, France, 75013 |
Principal Investigator: | Yves Dauvilliers, MD, PhD | CHRU Montpellier, France |
Documents provided by Theranexus:
Responsible Party: | Theranexus |
ClinicalTrials.gov Identifier: | NCT02821715 |
Other Study ID Numbers: |
THN102-201 2015-005035-41 ( EudraCT Number ) |
First Posted: | July 1, 2016 Key Record Dates |
Results First Posted: | September 4, 2020 |
Last Update Posted: | September 4, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Narcolepsy Sleepiness Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Flecainide Modafinil |
Central Nervous System Stimulants Physiological Effects of Drugs Wakefulness-Promoting Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators |