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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
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Theranexus

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.

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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


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




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. Daily sleepiness assessment [ Time Frame: Daily pattern (during the 14 days of treatment period) ]
    modified ESS, low score indicates good outcome

  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


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

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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: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Narcolepsy
Sleepiness
Signs and Symptoms
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