Narcolepsy
Conditions
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.
Interventions
DRUGActive comparator: Modafinil + placebo
DRUGTHN102 300/3
DRUGTHN102 300/27
Sponsors
Theranexus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale (ESS) | 14 days after the beginning of treatment period | Range 0 to 24, low score indicates good outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) | 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) | 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 | 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) | 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 | 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) |
| 14-item Fatigue Scale | 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 |
| Clinical Global Impression of Change (CGI-C) Cataplexy | 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 | 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 | 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 | 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) | 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 |
| Clinical Global Impression of Change (CGI-C) Sleepiness | 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) |
Countries
Belgium, France
Participant flow
Recruitment details
54 patients were screened, 51 patients were randomized and 48 started the double-blind treatment period
Pre-assignment details
Study starts with open-label run in period with modafinil 300 mg/d. 51 patients met study inclusion/exclusion criteria and entered the run-in period, 48 subjects still fulfilled inclusion criteria after run-in and entered the double-blind period.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants received either:
A Modafinil 300mg/d/Flecainide placebo, B Modafinil 300mg/d/Flecainide 3mg/d C Modafinil 300mg/d/Flecainide 27mg/d | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 35.7 years STANDARD_DEVIATION 9.96 | — |
| Epworth Sleepiness Scale (ESS) | 17.1 units on a scale STANDARD_DEVIATION 2.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 4 participants | — |
| Region of Enrollment France | 47 participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 27 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 9 / 48 | 15 / 47 | 13 / 47 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 | 0 / 48 |
Outcome results
Primary
Epworth Sleepiness Scale (ESS)
Range 0 to 24, low score indicates good outcome
Time frame: 14 days after the beginning of treatment period
Population: modified Intent To Treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Modafinil + Placebo | Epworth Sleepiness Scale (ESS) | 14.68 score on a scale | Standard Error 0.689 |
| THN102 300/3 | Epworth Sleepiness Scale (ESS) | 15.34 score on a scale | Standard Error 0.695 |
| THN102 300/27 | Epworth Sleepiness Scale (ESS) | 15.34 score on a scale | Standard Error 0.694 |
Secondary
14-item Fatigue Scale
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
Time frame: 14 days after the beginning of treatment period
Population: modified Intent To Treat (mITT)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Modafinil + Placebo | 14-item Fatigue Scale | 6.37 score on a scale | Standard Error 0.545 |
| THN102 300/3 | 14-item Fatigue Scale | 6.94 score on a scale | Standard Error 0.549 |
| THN102 300/27 | 14-item Fatigue Scale | 7.25 score on a scale | Standard Error 0.549 |
Secondary
Beck Depression Inventory (BDI)
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.
Time frame: 14 days
Population: mITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modafinil + Placebo | Beck Depression Inventory (BDI) | 6.3 score on a scale | Standard Deviation 5.17 |
| THN102 300/3 | Beck Depression Inventory (BDI) | 7.0 score on a scale | Standard Deviation 5.6 |
| THN102 300/27 | Beck Depression Inventory (BDI) | 7.0 score on a scale | Standard Deviation 6.16 |
Secondary
Clinical Global Impression for Severity (CGI-S) Cataplexy
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
Time frame: 14 days after the end of treatment period I
Population: modified Intent To Treat : mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Cataplexy | Borderline ill | 7 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Cataplexy | Normal, not ill at all | 7 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Cataplexy | Markedly ill | 4 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Cataplexy | Mildly ill | 10 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Cataplexy | Among the most extremely ill patients | 1 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Cataplexy | Moderately ill | 10 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Cataplexy | Severely ill | 2 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Moderately ill | 8 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Severely ill | 3 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Among the most extremely ill patients | 0 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Normal, not ill at all | 7 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Borderline ill | 8 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Mildly ill | 10 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Markedly ill | 5 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Borderline ill | 14 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Among the most extremely ill patients | 0 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Markedly ill | 0 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Normal, not ill at all | 5 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Severely ill | 6 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Moderately ill | 6 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Cataplexy | Mildly ill | 10 Participants |
Secondary
Clinical Global Impression for Severity (CGI-S) Global Score
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
Time frame: 14 days after the end of treatment period I
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Global Score | among the most extremely ill | 0 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Global Score | markedly ill | 14 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Global Score | moderately ill | 13 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Global Score | borderline ill | 5 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Global Score | normal, not ill at all | 2 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Global Score | severely ill | 3 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Global Score | mildly ill | 11 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Global Score | moderately ill | 18 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Global Score | normal, not ill at all | 0 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Global Score | borderline ill | 4 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Global Score | mildly ill | 8 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Global Score | markedly ill | 8 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Global Score | severely ill | 9 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Global Score | among the most extremely ill | 0 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Global Score | markedly ill | 5 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Global Score | borderline ill | 7 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Global Score | among the most extremely ill | 1 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Global Score | severely ill | 8 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Global Score | moderately ill | 14 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Global Score | mildly ill | 11 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Global Score | normal, not ill at all | 1 Participants |
Secondary
Clinical Global Impression for Severity (CGI-S) Sleepiness
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
Time frame: 14 days after the end of treatment period I
Population: modified Intent To Treat : mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Sleepiness | Among the most extremely ill patients | 0 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Sleepiness | Severely ill | 5 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Sleepiness | Mildly ill | 9 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Sleepiness | Markedly ill | 16 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Sleepiness | Normal, not ill at all | 2 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Sleepiness | Moderately ill | 10 Participants |
| Modafinil + Placebo | Clinical Global Impression for Severity (CGI-S) Sleepiness | Borderline ill | 6 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Moderately ill | 17 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Normal, not ill at all | 0 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Severely ill | 9 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Among the most extremely ill patients | 0 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Borderline ill | 3 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Mildly ill | 8 Participants |
| THN102 300/3 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Markedly ill | 10 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Among the most extremely ill patients | 1 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Normal, not ill at all | 1 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Borderline ill | 6 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Mildly ill | 10 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Markedly ill | 8 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Severely ill | 9 Participants |
| THN102 300/27 | Clinical Global Impression for Severity (CGI-S) Sleepiness | Moderately ill | 12 Participants |
Secondary
Clinical Global Impression of Change (CGI-C) Cataplexy
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)
Time frame: 14 days after the end of treatment period I
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Cataplexy | Minimally worse | 2 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Cataplexy | Very much improved | 2 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Cataplexy | very much worse | 0 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Cataplexy | Much worse | 0 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Cataplexy | Minimally improved | 6 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Cataplexy | Much improved | 1 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Cataplexy | No change | 29 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Cataplexy | Much worse | 0 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Cataplexy | No change | 32 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Cataplexy | very much worse | 0 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Cataplexy | Very much improved | 2 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Cataplexy | Minimally worse | 0 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Cataplexy | Much improved | 0 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Cataplexy | Minimally improved | 7 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Cataplexy | very much worse | 0 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Cataplexy | Minimally worse | 0 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Cataplexy | Very much improved | 0 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Cataplexy | Much improved | 1 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Cataplexy | Minimally improved | 7 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Cataplexy | No change | 33 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Cataplexy | Much worse | 0 Participants |
Secondary
Clinical Global Impression of Change (CGI-C) Global Impression
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)
Time frame: 14 days after the end of treatment period I
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Global Impression | Much improved | 7 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Global Impression | Minimally worse | 4 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Global Impression | no change | 14 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Global Impression | Very much improved | 3 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Global Impression | Very much worse | 0 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Global Impression | Much worse | 1 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Global Impression | Minimally improved | 18 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Global Impression | no change | 21 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Global Impression | Very much improved | 1 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Global Impression | Much improved | 10 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Global Impression | Minimally improved | 9 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Global Impression | Minimally worse | 3 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Global Impression | Much worse | 2 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Global Impression | Very much worse | 1 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Global Impression | Minimally worse | 5 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Global Impression | Much improved | 8 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Global Impression | Very much worse | 0 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Global Impression | Much worse | 0 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Global Impression | no change | 21 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Global Impression | Minimally improved | 13 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Global Impression | Very much improved | 0 Participants |
Secondary
Clinical Global Impression of Change (CGI-C) Sleepiness
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)
Time frame: 14 days after the end of treatment period I
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Sleepiness | Very much worse | 0 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Sleepiness | Very much improved | 6 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Sleepiness | Much improved | 5 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Sleepiness | Minimally improved | 16 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Sleepiness | No change | 14 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Sleepiness | Minimally worse | 3 Participants |
| Modafinil + Placebo | Clinical Global Impression of Change (CGI-C) Sleepiness | Much worse | 3 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Sleepiness | Much worse | 3 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Sleepiness | Minimally improved | 10 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Sleepiness | No change | 17 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Sleepiness | Very much worse | 0 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Sleepiness | Minimally worse | 4 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Sleepiness | Very much improved | 2 Participants |
| THN102 300/3 | Clinical Global Impression of Change (CGI-C) Sleepiness | Much improved | 11 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Sleepiness | Very much worse | 0 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Sleepiness | Minimally worse | 6 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Sleepiness | Minimally improved | 11 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Sleepiness | Much worse | 1 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Sleepiness | Much improved | 9 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Sleepiness | No change | 20 Participants |
| THN102 300/27 | Clinical Global Impression of Change (CGI-C) Sleepiness | Very much improved | 0 Participants |
Secondary
EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)
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
Time frame: 14 days
Population: mITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modafinil + Placebo | EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part) | 70.10 units on a scale | Standard Error 2.6 |
| THN102 300/3 | EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part) | 66.13 units on a scale | Standard Error 2.601 |
| THN102 300/27 | EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part) | 66.72 units on a scale | Standard Error 2.6 |
Secondary
Patient Global Impression for Severity (PGI-S) Global Score
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)
Time frame: 14 days
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modafinil + Placebo | Patient Global Impression for Severity (PGI-S) Global Score | severely ill | 0 Participants |
| Modafinil + Placebo | Patient Global Impression for Severity (PGI-S) Global Score | normal Not ill at all | 10 Participants |
| Modafinil + Placebo | Patient Global Impression for Severity (PGI-S) Global Score | mildly ill | 9 Participants |
| Modafinil + Placebo | Patient Global Impression for Severity (PGI-S) Global Score | markedly ill | 8 Participants |
| Modafinil + Placebo | Patient Global Impression for Severity (PGI-S) Global Score | borderline ill | 8 Participants |
| Modafinil + Placebo | Patient Global Impression for Severity (PGI-S) Global Score | moderately ill | 12 Participants |
| THN102 300/3 | Patient Global Impression for Severity (PGI-S) Global Score | borderline ill | 10 Participants |
| THN102 300/3 | Patient Global Impression for Severity (PGI-S) Global Score | markedly ill | 6 Participants |
| THN102 300/3 | Patient Global Impression for Severity (PGI-S) Global Score | severely ill | 1 Participants |
| THN102 300/3 | Patient Global Impression for Severity (PGI-S) Global Score | moderately ill | 13 Participants |
| THN102 300/3 | Patient Global Impression for Severity (PGI-S) Global Score | mildly ill | 7 Participants |
| THN102 300/3 | Patient Global Impression for Severity (PGI-S) Global Score | normal Not ill at all | 9 Participants |
| THN102 300/27 | Patient Global Impression for Severity (PGI-S) Global Score | severely ill | 3 Participants |
| THN102 300/27 | Patient Global Impression for Severity (PGI-S) Global Score | normal Not ill at all | 8 Participants |
| THN102 300/27 | Patient Global Impression for Severity (PGI-S) Global Score | borderline ill | 10 Participants |
| THN102 300/27 | Patient Global Impression for Severity (PGI-S) Global Score | mildly ill | 9 Participants |
| THN102 300/27 | Patient Global Impression for Severity (PGI-S) Global Score | moderately ill | 11 Participants |
| THN102 300/27 | Patient Global Impression for Severity (PGI-S) Global Score | markedly ill | 5 Participants |
Secondary
Patient Global Impression of Change (PGI-C)
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)
Time frame: 14 days after the beginning of treatment period
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modafinil + Placebo | Patient Global Impression of Change (PGI-C) | Much improved | 10 Participants |
| Modafinil + Placebo | Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Modafinil + Placebo | Patient Global Impression of Change (PGI-C) | Minimally worse | 8 Participants |
| Modafinil + Placebo | Patient Global Impression of Change (PGI-C) | Minimally improved | 16 Participants |
| Modafinil + Placebo | Patient Global Impression of Change (PGI-C) | Very much improved | 2 Participants |
| Modafinil + Placebo | Patient Global Impression of Change (PGI-C) | No change | 10 Participants |
| Modafinil + Placebo | Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| THN102 300/3 | Patient Global Impression of Change (PGI-C) | Minimally improved | 15 Participants |
| THN102 300/3 | Patient Global Impression of Change (PGI-C) | No change | 12 Participants |
| THN102 300/3 | Patient Global Impression of Change (PGI-C) | Very much improved | 1 Participants |
| THN102 300/3 | Patient Global Impression of Change (PGI-C) | Much improved | 7 Participants |
| THN102 300/3 | Patient Global Impression of Change (PGI-C) | Minimally worse | 7 Participants |
| THN102 300/3 | Patient Global Impression of Change (PGI-C) | Much worse | 3 Participants |
| THN102 300/3 | Patient Global Impression of Change (PGI-C) | Very much worse | 1 Participants |
| THN102 300/27 | Patient Global Impression of Change (PGI-C) | Minimally worse | 8 Participants |
| THN102 300/27 | Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| THN102 300/27 | Patient Global Impression of Change (PGI-C) | Very much worse | 1 Participants |
| THN102 300/27 | Patient Global Impression of Change (PGI-C) | Much worse | 1 Participants |
| THN102 300/27 | Patient Global Impression of Change (PGI-C) | No change | 17 Participants |
| THN102 300/27 | Patient Global Impression of Change (PGI-C) | Much improved | 9 Participants |
| THN102 300/27 | Patient Global Impression of Change (PGI-C) | Minimally improved | 10 Participants |
Secondary
Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)
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.
Time frame: 14 days after the beginning of the screening
Population: mITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modafinil + Placebo | Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) | 0.86 score on a scale | Standard Error 0.358 |
| THN102 300/3 | Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) | 1.16 score on a scale | Standard Error 0.189 |
| THN102 300/27 | Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) | 1.24 score on a scale | Standard Error 0.258 |