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Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02821715
Recruitment Status : Completed
First Posted : July 1, 2016
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Theranexus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Narcolepsy
Interventions Drug: Active comparator: Modafinil + placebo
Drug: THN102 300/3
Drug: THN102 300/27
Enrollment 51
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.
Arm/Group Title Sequence 1 : ABC Sequence 2 : BCA Sequence 3: CAB Sequence 4: ACB Sequence 5: CBA Sequence 6: BAC
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Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day

Treatment period A, B and C duration = 2 weeks No wash out between each period

Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day

Treatment period A, B and C duration = 2 weeks No wash out between each period

Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day

Treatment period A, B and C duration = 2 weeks No wash out between each period

Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day

Treatment period A, B and C duration = 2 weeks No wash out between each period

Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day

Treatment period A, B and C duration = 2 weeks No wash out between each period

Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day

Treatment period A, B and C duration = 2 weeks No wash out between each period

Period Title: Overall Study
Started 8 8 8 9 6 9
Completed 7 8 8 9 6 9
Not Completed 1 0 0 0 0 0
Reason Not Completed
Protocol Violation             1             0             0             0             0             0
Arm/Group Title All Participants
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Participants received either:

A Modafinil 300mg/d/Flecainide placebo, B Modafinil 300mg/d/Flecainide 3mg/d C Modafinil 300mg/d/Flecainide 27mg/d

Overall Number of Baseline Participants 51
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Ethnicity data not collected at baseline
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
35.7  (9.96)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
24
  47.1%
Male
27
  52.9%
[1]
Measure Analysis Population Description: 51 patients were randomised (1 randomized patient never took study medication), Safety set: 50 patients Modified Intent to Treat Set: 48 patients
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Belgium Number Analyzed 51 participants
4
France Number Analyzed 51 participants
47
Epworth Sleepiness Scale (ESS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 48 participants
17.1  (2.8)
[1]
Measure Description: Score from 0 to 24, high score = severe sleepiness
[2]
Measure Analysis Population Description: Efficacy population (modified Intent to Treat Population) 48
1.Primary Outcome
Title Epworth Sleepiness Scale (ESS)
Hide Description Range 0 to 24, low score indicates good outcome
Time Frame 14 days after the beginning of treatment period
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modified Intent To Treat population
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
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3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 48 48 48
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
14.68  (0.689) 15.34  (0.695) 15.34  (0.694)
2.Secondary Outcome
Title 14-item Fatigue Scale
Hide Description 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
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modified Intent To Treat (mITT)
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
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3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 47 47 46
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
6.37  (0.545) 6.94  (0.549) 7.25  (0.549)
3.Secondary Outcome
Title Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)
Hide Description

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
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Hide Analysis Population Description
mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
Hide Arm/Group Description:

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

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 47 46 46
Mean (Standard Error)
Unit of Measure: score on a scale
0.86  (0.358) 1.16  (0.189) 1.24  (0.258)
4.Secondary Outcome
Title Patient Global Impression of Change (PGI-C)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
Hide Arm/Group Description:

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

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 46 46 46
Measure Type: Count of Participants
Unit of Measure: Participants
Very much improved
2
   4.3%
1
   2.2%
0
   0.0%
Much improved
10
  21.7%
7
  15.2%
9
  19.6%
Minimally improved
16
  34.8%
15
  32.6%
10
  21.7%
No change
10
  21.7%
12
  26.1%
17
  37.0%
Minimally worse
8
  17.4%
7
  15.2%
8
  17.4%
Much worse
0
   0.0%
3
   6.5%
1
   2.2%
Very much worse
0
   0.0%
1
   2.2%
1
   2.2%
5.Secondary Outcome
Title Clinical Global Impression of Change (CGI-C) Global Impression
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
Hide Arm/Group Description:

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

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 47 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
Very much improved
3
   6.4%
1
   2.1%
0
   0.0%
Much improved
7
  14.9%
10
  21.3%
8
  17.0%
Minimally improved
18
  38.3%
9
  19.1%
13
  27.7%
no change
14
  29.8%
21
  44.7%
21
  44.7%
Minimally worse
4
   8.5%
3
   6.4%
5
  10.6%
Much worse
1
   2.1%
2
   4.3%
0
   0.0%
Very much worse
0
   0.0%
1
   2.1%
0
   0.0%
6.Secondary Outcome
Title Beck Depression Inventory (BDI)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
Hide Arm/Group Description:

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

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 47 47 46
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.3  (5.17) 7.0  (5.60) 7.0  (6.16)
7.Secondary Outcome
Title Patient Global Impression for Severity (PGI-S) Global Score
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
Hide Arm/Group Description:

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

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 47 46 46
Measure Type: Count of Participants
Unit of Measure: Participants
normal Not ill at all
10
  21.3%
9
  19.6%
8
  17.4%
borderline ill
8
  17.0%
10
  21.7%
10
  21.7%
mildly ill
9
  19.1%
7
  15.2%
9
  19.6%
moderately ill
12
  25.5%
13
  28.3%
11
  23.9%
markedly ill
8
  17.0%
6
  13.0%
5
  10.9%
severely ill
0
   0.0%
1
   2.2%
3
   6.5%
8.Secondary Outcome
Title Clinical Global Impression of Change (CGI-C) Sleepiness
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
Hide Arm/Group Description:

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

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 47 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
Very much improved
6
  12.8%
2
   4.3%
0
   0.0%
Much improved
5
  10.6%
11
  23.4%
9
  19.1%
Minimally improved
16
  34.0%
10
  21.3%
11
  23.4%
No change
14
  29.8%
17
  36.2%
20
  42.6%
Minimally worse
3
   6.4%
4
   8.5%
6
  12.8%
Much worse
3
   6.4%
3
   6.4%
1
   2.1%
Very much worse
0
   0.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Clinical Global Impression of Change (CGI-C) Cataplexy
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
Hide Arm/Group Description:

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

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 40 41 41
Measure Type: Count of Participants
Unit of Measure: Participants
Very much improved
2
   5.0%
2
   4.9%
0
   0.0%
Much improved
1
   2.5%
0
   0.0%
1
   2.4%
Minimally improved
6
  15.0%
7
  17.1%
7
  17.1%
No change
29
  72.5%
32
  78.0%
33
  80.5%
Minimally worse
2
   5.0%
0
   0.0%
0
   0.0%
Much worse
0
   0.0%
0
   0.0%
0
   0.0%
very much worse
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Clinical Global Impression for Severity (CGI-S) Global Score
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
Hide Arm/Group Description:

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

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 48 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
normal, not ill at all
2
   4.2%
0
   0.0%
1
   2.1%
borderline ill
5
  10.4%
4
   8.5%
7
  14.9%
mildly ill
11
  22.9%
8
  17.0%
11
  23.4%
moderately ill
13
  27.1%
18
  38.3%
14
  29.8%
markedly ill
14
  29.2%
8
  17.0%
5
  10.6%
severely ill
3
   6.3%
9
  19.1%
8
  17.0%
among the most extremely ill
0
   0.0%
0
   0.0%
1
   2.1%
11.Secondary Outcome
Title Clinical Global Impression for Severity (CGI-S) Sleepiness
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent To Treat : mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
Hide Arm/Group Description:

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

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 48 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
Normal, not ill at all
2
   4.2%
0
   0.0%
1
   2.1%
Borderline ill
6
  12.5%
3
   6.4%
6
  12.8%
Mildly ill
9
  18.8%
8
  17.0%
10
  21.3%
Moderately ill
10
  20.8%
17
  36.2%
12
  25.5%
Markedly ill
16
  33.3%
10
  21.3%
8
  17.0%
Severely ill
5
  10.4%
9
  19.1%
9
  19.1%
Among the most extremely ill patients
0
   0.0%
0
   0.0%
1
   2.1%
12.Secondary Outcome
Title Clinical Global Impression for Severity (CGI-S) Cataplexy
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent To Treat : mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
Hide Arm/Group Description:

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

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 41 41 41
Measure Type: Count of Participants
Unit of Measure: Participants
Normal, not ill at all
7
  17.1%
7
  17.1%
5
  12.2%
Borderline ill
7
  17.1%
8
  19.5%
14
  34.1%
Mildly ill
10
  24.4%
10
  24.4%
10
  24.4%
Moderately ill
10
  24.4%
8
  19.5%
6
  14.6%
Markedly ill
4
   9.8%
5
  12.2%
0
   0.0%
Severely ill
2
   4.9%
3
   7.3%
6
  14.6%
Among the most extremely ill patients
1
   2.4%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)
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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
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mITT
Arm/Group Title Modafinil + Placebo THN102 300/3 THN102 300/27
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3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks

Active comparator: Modafinil + placebo

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

THN102 300/3

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

THN102 300/27

Overall Number of Participants Analyzed 47 46 46
Mean (Standard Error)
Unit of Measure: units on a scale
70.10  (2.600) 66.13  (2.601) 66.72  (2.600)
Time Frame Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse Event Reporting Description Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
 
Arm/Group Title THN102 300/0 THN102 300/3 THN102 300/27
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Treatment A : THN102 300/0 Modafinil 300 mg/d Flecainide placebo

Duration : 2 weeks

Treatment B : THN102 300/3 Modafinil 300 mg/d Flecainide 3 mg/d Duration : 2 weeks Treatment C : THN102 300/27 Modafinil 300 mg/d Flecainide 27 mg/d Duration : 2 weeks
All-Cause Mortality
THN102 300/0 THN102 300/3 THN102 300/27
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%)   0/48 (0.00%) 
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THN102 300/0 THN102 300/3 THN102 300/27
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%)   0/48 (0.00%) 
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Frequency Threshold for Reporting Other Adverse Events 0%
THN102 300/0 THN102 300/3 THN102 300/27
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/48 (18.75%)   15/47 (31.91%)   13/47 (27.66%) 
Cardiac disorders       
Palpitation  1  1/48 (2.08%)  0/47 (0.00%)  0/47 (0.00%) 
Ear and labyrinth disorders       
vertigo  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Eye disorders       
chalazion  1  0/48 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
Gastrointestinal disorders       
Abdominal pain upper  1  1/48 (2.08%)  0/47 (0.00%)  0/47 (0.00%) 
constipation  1  0/48 (0.00%)  1/47 (2.13%)  1/47 (2.13%) 
dry mouth  1  0/48 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
toothache  1  1/48 (2.08%)  0/47 (0.00%)  0/47 (0.00%) 
General disorders       
asthenia  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
fatigue  1  0/48 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
hunger  1  0/48 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
sluggishness  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Immune system disorders       
food allergy  1  0/48 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
Infections and infestations       
gastroenteritis  1  0/48 (0.00%)  2/47 (4.26%)  0/47 (0.00%) 
influenza  1  0/48 (0.00%)  2/47 (4.26%)  0/47 (0.00%) 
laryngitis  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
nasopharyngitis  1  0/48 (0.00%)  2/47 (4.26%)  2/47 (4.26%) 
tracheitis  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
urinary tact infection  1  1/48 (2.08%)  0/47 (0.00%)  0/47 (0.00%) 
Injury, poisoning and procedural complications       
limb injury  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Investigations       
hepatic enzyme increase  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Metabolism and nutrition disorders       
pain in extremity  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Musculoskeletal and connective tissue disorders       
arthralgia  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Nervous system disorders       
balance disorder  1  1/48 (2.08%)  0/47 (0.00%)  0/47 (0.00%) 
dizziness  1  1/48 (2.08%)  0/47 (0.00%)  2/47 (4.26%) 
dysgeusia  1  0/48 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
headache  1  2/48 (4.17%)  2/47 (4.26%)  1/47 (2.13%) 
Psychiatric disorders       
irritability  1  0/48 (0.00%)  1/47 (2.13%)  1/47 (2.13%) 
nightmare  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
violence related symptom  1  1/48 (2.08%)  0/47 (0.00%)  0/47 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
oropharyngeal pain  1  1/48 (2.08%)  0/47 (0.00%)  0/47 (0.00%) 
rhinitis allergic  1  0/48 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Skin and subcutaneous tissue disorders       
hyperhidrosis  1  1/48 (2.08%)  1/47 (2.13%)  0/47 (0.00%) 
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Chief medical officer
Organization: Theranexus
Phone: +33680026779
EMail: werner.rein@theranexus.fr
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Responsible Party: Theranexus
ClinicalTrials.gov Identifier: NCT02821715    
Other Study ID Numbers: THN102-201
2015-005035-41 ( EudraCT Number )
First Submitted: June 23, 2016
First Posted: July 1, 2016
Results First Submitted: May 26, 2020
Results First Posted: September 4, 2020
Last Update Posted: September 4, 2020