Phase 2
N=48
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
Narcolepsy
Bottom Line
View on ClinicalTrials.gov: NCT02821715 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Epworth Sleepiness Scale (ESS) — 14.68; 15.34; 15.34 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Active comparator: Modafinil + placebo (Drug); THN102 300/3 (Drug); THN102 300/27 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Theranexus
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epworth Sleepiness Scale (ESS) |
14.68; 15.34; 15.34 | — |
| SECONDARY 14-item Fatigue Scale |
6.37; 6.94; 7.25 | — |
| SECONDARY Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) |
0.86; 1.16; 1.24 | — |
| SECONDARY Patient Global Impression of Change (PGI-C) |
2; 1; 0; 10; 7; 9 | — |
| SECONDARY Clinical Global Impression of Change (CGI-C) Global Impression |
3; 1; 0; 7; 10; 8 | — |
| SECONDARY Beck Depression Inventory (BDI) |
6.3; 7.0; 7.0 | — |
| SECONDARY Patient Global Impression for Severity (PGI-S) Global Score |
10; 9; 8; 8; 10; 10 | — |
| SECONDARY Clinical Global Impression of Change (CGI-C) Sleepiness |
6; 2; 0; 5; 11; 9 | — |
| SECONDARY Clinical Global Impression of Change (CGI-C) Cataplexy |
2; 2; 0; 1; 0; 1 | — |
| SECONDARY Clinical Global Impression for Severity (CGI-S) Global Score |
2; 0; 1; 5; 4; 7 | — |
| SECONDARY Clinical Global Impression for Severity (CGI-S) Sleepiness |
2; 0; 1; 6; 3; 6 | — |
| SECONDARY Clinical Global Impression for Severity (CGI-S) Cataplexy |
7; 7; 5; 7; 8; 14 | — |
| SECONDARY EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part) |
70.10; 66.13; 66.72 | — |
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).
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT02821715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.