Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

NCT02821715 | Completed Phase 2 Results

• 2 other identifiers: THN102-2012015-005035-41
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 8

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).

Conditions

Narcolepsy

Outcome Measures

Primary Outcomes (1)

• Epworth Sleepiness Scale (ESS)

  Range 0 to 24, low score indicates good outcome

  14 days after the beginning of treatment period

Secondary Outcomes (12)

• 14-item Fatigue Scale

  14 days after the beginning of treatment period

• Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)

  14 days after the beginning of the screening

• Patient Global Impression of Change (PGI-C)

  14 days after the beginning of treatment period

• Clinical Global Impression of Change (CGI-C) Global Impression

  14 days after the end of treatment period I

• Beck Depression Inventory (BDI)

  14 days

Study Arms (3)

Modafinil + placebo

ACTIVE COMPARATOR

3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks

Drug: Active comparator: Modafinil + placebo

THN102 300/3

EXPERIMENTAL

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

THN102 300/27

EXPERIMENTAL

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

Interventions

Active comparator: Modafinil + placebo DRUG

Also known as: Modafinil 300 mg, Flecainide Placebo

Modafinil + placebo

THN102 300/3 DRUG

Also known as: Modafinil 300 mg, Flecainide 3 mg

THN102 300/3

THN102 300/27 DRUG

Also known as: Modafinil 300 mg, Flecainide 27 mg

THN102 300/27

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Theranexus: lead

Study Sites (8)

RespiSom

Erpent, Belgium

Location

CHU Pellegrin

Bordeaux, 33076, France

Location

CHU Dijon Bourgogne

Dijon, France

Location

Hôpital Raymond Poincaré

Garches, 92380, France

Location

CHU Grenoble Alpes

Grenoble, France

Location

CHRU Lilles

Lille, 59037, France

Location

University Hospital

Montpellier, 34090, France

Location

Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Narcolepsy

Interventions

Modafinil; Flecainide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief medical officer
• Organization: Theranexus

werner.rein@theranexus.fr

+33680026779

Study Officials

• Yves Dauvilliers, MD, PhD

  CHRU Montpellier, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 1, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-08

Locations

BE (1); FR (7)