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Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

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ClinicalTrials.gov Identifier: NCT02821715
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Theranexus

Brief Summary:
This Phase 2 study is a 3-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: THN102 300/3 Drug: THN102 300/27 Drug: Modafinil 300 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Modafinil
3 tablets modafinil 100 mg + 3 capsules placebo
Drug: Modafinil 300
Experimental: THN102 300/3
3 tablets modafinil 100 mg + 3 capsules flecainide 1 mg (THN102 as 300 + 3 mg)
Drug: THN102 300/3
Experimental: THN102 300/27
3 tablets modafinil 100 mg + 3 capsules flecainide 9 mg (THN102 as 300 + 27 mg)
Drug: THN102 300/27



Primary Outcome Measures :
  1. Epworth Sleepiness Scale (ESS) [ Time Frame: 14 days after the beginning of treatment period ]

Secondary Outcome Measures :
  1. Daily sleepiness assessment [ Time Frame: Daily pattern (during the 14 days of treatment period) ]
  2. 14-item Fatigue Scale [ Time Frame: 14 days after the beginning of treatment period ]
  3. EQ-5D [ Time Frame: 14 days after the beginning of treatment period ]
  4. Patient Global Impression of Change (PGI-C) [ Time Frame: 14 days after the beginning of treatment period ]
  5. Clinical Global Impression of Change (CGI-C) [ Time Frame: 14 days after the beginning of treatment period ]
  6. Beck Depression Inventory (BDI) [ Time Frame: 14 days after the beginning of treatment period ]


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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

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


Contacts
Contact: Mathieu Charvériat mathieu.charveriat@theranexus.com
Contact: Werner Rein werner.rein@theranexus.fr

Locations
France
CHU Pellegrin Recruiting
Bordeaux, France, 33076
Contact: Pierre Philip         
Hôpital Raymond Poincaré Recruiting
Garches, France, 92380
Contact: Maria-Antonia Quera-Salva         
CHRU Lilles Recruiting
Lille, France, 59037
Contact: Christelle Charley-Monaca         
Contact       christelle.monaca@chru-lille.fr   
University Hospital Recruiting
Montpellier, France, 34090
Contact: Yves Dauvilliers       y-dauvilliers@chu-montpellier.fr   
Groupe Hospitalier Pitié Salpêtrière Recruiting
Paris, France, 75013
Contact: Isabelle Arnulf       isabelle.arnulf@aphp.fr   
Sponsors and Collaborators
Theranexus
Investigators
Principal Investigator: Yves Dauvilliers, MD, PhD CHRU Montpellier, France

Responsible Party: Theranexus
ClinicalTrials.gov Identifier: NCT02821715     History of Changes
Other Study ID Numbers: THN102-201
2015-005035-41 ( EudraCT Number )
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs