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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

Tracking Information
First Submitted Date  ICMJE June 23, 2016
First Posted Date  ICMJE July 1, 2016
Results First Submitted Date  ICMJE May 26, 2020
Results First Posted Date  ICMJE September 4, 2020
Last Update Posted Date September 4, 2020
Study Start Date  ICMJE September 2016
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
Epworth Sleepiness Scale (ESS) [ Time Frame: 14 days after the beginning of treatment period ]
Range 0 to 24, low score indicates good outcome
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
Epworth Sleepiness Scale (ESS) [ Time Frame: 14 days after the beginning of treatment period ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
  • Daily sleepiness assessment [ Time Frame: Daily pattern (during the 14 days of treatment period) ]
  • 14-item Fatigue Scale [ Time Frame: 14 days after the beginning of treatment period ]
  • EQ-5D [ Time Frame: 14 days after the beginning of treatment period ]
  • PGI-C [ Time Frame: 14 days after the beginning of treatment period ]
  • CGI-C [ Time Frame: 14 days after the beginning of treatment period ]
  • Beck Depression Inventory (BDI) [ Time Frame: 14 days after the beginning of treatment period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
Official Title  ICMJE Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Narcolepsy
Intervention  ICMJE
  • Drug: Active comparator: Modafinil + placebo
    Other Names:
    • Modafinil 300 mg
    • Flecainide Placebo
  • Drug: THN102 300/3
    Other Names:
    • Modafinil 300 mg
    • Flecainide 3 mg
  • Drug: THN102 300/27
    Other Names:
    • Modafinil 300 mg
    • Flecainide 27 mg
Study Arms  ICMJE
  • Active Comparator: Modafinil + placebo
    3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
    Intervention: Drug: Active comparator: Modafinil + 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
    Intervention: Drug: THN102 300/3
  • 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
    Intervention: Drug: THN102 300/27
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2019)
51
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2016)
48
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02821715
Other Study ID Numbers  ICMJE THN102-201
2015-005035-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Theranexus
Study Sponsor  ICMJE Theranexus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yves Dauvilliers, MD, PhD CHRU Montpellier, France
PRS Account Theranexus
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP