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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
Sponsor:
Information provided by (Responsible Party):
Theranexus

Study Description
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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).

Condition or disease Intervention/treatment Phase
Narcolepsy Drug: Active comparator: Modafinil + placebo Drug: THN102 300/3 Drug: THN102 300/27 Phase 2

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Modafinil + placebo
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
 Drug: Active comparator: Modafinil + placebo
Other Names:
  • Modafinil 300 mg
  • Flecainide Placebo
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
 Drug: THN102 300/3
Other Names:
  • Modafinil 300 mg
  • Flecainide 3 mg
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
 Drug: THN102 300/27
Other Names:
  • Modafinil 300 mg
  • Flecainide 27 mg


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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



Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Theranexus
Investigators
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Principal Investigator: Yves Dauvilliers, MD, PhD CHRU Montpellier, France
  Study Documents (Full-Text)

Documents provided by Theranexus:
Statistical Analysis Plan  [PDF] January 24, 2019
Study Protocol  [PDF] May 11, 2018

More Information
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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
Additional relevant MeSH terms:
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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