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Completed

NCT Number: NCT02821715

Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

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).

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Key information

Conditions

Narcolepsy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

RespiSom, Erpent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active comparator: Modafinil + placebo

Drug

Other names: Modafinil 300 mg, Flecainide Placebo

THN102 300/3

Drug

Other names: Modafinil 300 mg, Flecainide 3 mg

THN102 300/27

Drug

Other names: Modafinil 300 mg, Flecainide 27 mg

Primary outcomes

  1. Epworth Sleepiness Scale (ESS)

    Time frame: 14 days after the beginning of treatment period

    Range 0 to 24, low score indicates good outcome

Secondary outcomes

  1. 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

  2. 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.

  3. 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)

  4. 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)

  5. 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.

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Theranexus

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 1, 2016
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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