Trial Outcomes & Findings for Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients (NCT NCT02821715)
NCT ID: NCT02821715
Last Updated: 2020-09-04
Results Overview
Range 0 to 24, low score indicates good outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
14 days after the beginning of treatment period
Results posted on
2020-09-04
Participant Flow
54 patients were screened, 51 patients were randomized and 48 started the double-blind treatment period
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.
Participant milestones
| Measure |
Sequence 1 : ABC
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
|
Sequence 2 : BCA
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
|
Sequence 3: CAB
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
|
Sequence 4: ACB
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
|
Sequence 5: CBA
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
|
Sequence 6: BAC
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
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
9
|
6
|
9
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
9
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1 : ABC
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
|
Sequence 2 : BCA
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
|
Sequence 3: CAB
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
|
Sequence 4: ACB
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
|
Sequence 5: CBA
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
|
Sequence 6: BAC
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
|
|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
51 patients were randomised (1 randomized patient never took study medication), Safety set: 50 patients Modified Intent to Treat Set: 48 patients
Baseline characteristics by cohort
| Measure |
All Participants
n=51 Participants
Participants received either:
A Modafinil 300mg/d/Flecainide placebo, B Modafinil 300mg/d/Flecainide 3mg/d C Modafinil 300mg/d/Flecainide 27mg/d
|
|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 9.96 • n=51 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=51 Participants • 51 patients were randomised (1 randomized patient never took study medication), Safety set: 50 patients Modified Intent to Treat Set: 48 patients
|
|
Sex: Female, Male
Male
|
27 Participants
n=51 Participants • 51 patients were randomised (1 randomized patient never took study medication), Safety set: 50 patients Modified Intent to Treat Set: 48 patients
|
|
Region of Enrollment
Belgium
|
4 participants
n=51 Participants
|
|
Region of Enrollment
France
|
47 participants
n=51 Participants
|
|
Epworth Sleepiness Scale (ESS)
|
17.1 units on a scale
STANDARD_DEVIATION 2.8 • n=48 Participants • Efficacy population (modified Intent to Treat Population) 48
|
PRIMARY outcome
Timeframe: 14 days after the beginning of treatment periodPopulation: modified Intent To Treat population
Range 0 to 24, low score indicates good outcome
Outcome measures
| Measure |
Modafinil + Placebo
n=48 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=48 Participants
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
|
THN102 300/27
n=48 Participants
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
|
|---|---|---|---|
|
Epworth Sleepiness Scale (ESS)
|
14.68 score on a scale
Standard Error 0.689
|
15.34 score on a scale
Standard Error 0.695
|
15.34 score on a scale
Standard Error 0.694
|
SECONDARY outcome
Timeframe: 14 days after the beginning of treatment periodPopulation: modified Intent To Treat (mITT)
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
Outcome measures
| Measure |
Modafinil + Placebo
n=47 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=47 Participants
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
|
THN102 300/27
n=46 Participants
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
|
|---|---|---|---|
|
14-item Fatigue Scale
|
6.37 score on a scale
Standard Error 0.545
|
6.94 score on a scale
Standard Error 0.549
|
7.25 score on a scale
Standard Error 0.549
|
SECONDARY outcome
Timeframe: 14 days after the beginning of the screeningPopulation: mITT
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.
Outcome measures
| Measure |
Modafinil + Placebo
n=47 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=46 Participants
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
|
THN102 300/27
n=46 Participants
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
|
|---|---|---|---|
|
Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)
|
0.86 score on a scale
Standard Error 0.358
|
1.16 score on a scale
Standard Error 0.189
|
1.24 score on a scale
Standard Error 0.258
|
SECONDARY outcome
Timeframe: 14 days after the beginning of treatment periodPopulation: mITT
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)
Outcome measures
| Measure |
Modafinil + Placebo
n=46 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=46 Participants
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
|
THN102 300/27
n=46 Participants
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
|
|---|---|---|---|
|
Patient Global Impression of Change (PGI-C)
Very much worse
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGI-C)
Very much improved
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGI-C)
Much improved
|
10 Participants
|
7 Participants
|
9 Participants
|
|
Patient Global Impression of Change (PGI-C)
Minimally improved
|
16 Participants
|
15 Participants
|
10 Participants
|
|
Patient Global Impression of Change (PGI-C)
No change
|
10 Participants
|
12 Participants
|
17 Participants
|
|
Patient Global Impression of Change (PGI-C)
Minimally worse
|
8 Participants
|
7 Participants
|
8 Participants
|
|
Patient Global Impression of Change (PGI-C)
Much worse
|
0 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 14 days after the end of treatment period IPopulation: mITT
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)
Outcome measures
| Measure |
Modafinil + Placebo
n=47 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=47 Participants
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
|
THN102 300/27
n=47 Participants
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
|
|---|---|---|---|
|
Clinical Global Impression of Change (CGI-C) Global Impression
Very much worse
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Global Impression of Change (CGI-C) Global Impression
Very much improved
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Global Impression of Change (CGI-C) Global Impression
Much improved
|
7 Participants
|
10 Participants
|
8 Participants
|
|
Clinical Global Impression of Change (CGI-C) Global Impression
Minimally improved
|
18 Participants
|
9 Participants
|
13 Participants
|
|
Clinical Global Impression of Change (CGI-C) Global Impression
no change
|
14 Participants
|
21 Participants
|
21 Participants
|
|
Clinical Global Impression of Change (CGI-C) Global Impression
Minimally worse
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Clinical Global Impression of Change (CGI-C) Global Impression
Much worse
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: mITT
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.
Outcome measures
| Measure |
Modafinil + Placebo
n=47 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=47 Participants
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
|
THN102 300/27
n=46 Participants
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
|
|---|---|---|---|
|
Beck Depression Inventory (BDI)
|
6.3 score on a scale
Standard Deviation 5.17
|
7.0 score on a scale
Standard Deviation 5.60
|
7.0 score on a scale
Standard Deviation 6.16
|
SECONDARY outcome
Timeframe: 14 daysPopulation: mITT
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)
Outcome measures
| Measure |
Modafinil + Placebo
n=47 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=46 Participants
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
|
THN102 300/27
n=46 Participants
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
|
|---|---|---|---|
|
Patient Global Impression for Severity (PGI-S) Global Score
normal Not ill at all
|
10 Participants
|
9 Participants
|
8 Participants
|
|
Patient Global Impression for Severity (PGI-S) Global Score
borderline ill
|
8 Participants
|
10 Participants
|
10 Participants
|
|
Patient Global Impression for Severity (PGI-S) Global Score
mildly ill
|
9 Participants
|
7 Participants
|
9 Participants
|
|
Patient Global Impression for Severity (PGI-S) Global Score
moderately ill
|
12 Participants
|
13 Participants
|
11 Participants
|
|
Patient Global Impression for Severity (PGI-S) Global Score
markedly ill
|
8 Participants
|
6 Participants
|
5 Participants
|
|
Patient Global Impression for Severity (PGI-S) Global Score
severely ill
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 14 days after the end of treatment period IPopulation: mITT
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)
Outcome measures
| Measure |
Modafinil + Placebo
n=47 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=47 Participants
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
|
THN102 300/27
n=47 Participants
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
|
|---|---|---|---|
|
Clinical Global Impression of Change (CGI-C) Sleepiness
Very much improved
|
6 Participants
|
2 Participants
|
0 Participants
|
|
Clinical Global Impression of Change (CGI-C) Sleepiness
Much improved
|
5 Participants
|
11 Participants
|
9 Participants
|
|
Clinical Global Impression of Change (CGI-C) Sleepiness
Minimally improved
|
16 Participants
|
10 Participants
|
11 Participants
|
|
Clinical Global Impression of Change (CGI-C) Sleepiness
No change
|
14 Participants
|
17 Participants
|
20 Participants
|
|
Clinical Global Impression of Change (CGI-C) Sleepiness
Minimally worse
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Clinical Global Impression of Change (CGI-C) Sleepiness
Much worse
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Clinical Global Impression of Change (CGI-C) Sleepiness
Very much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 days after the end of treatment period IPopulation: mITT
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)
Outcome measures
| Measure |
Modafinil + Placebo
n=40 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=41 Participants
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
|
THN102 300/27
n=41 Participants
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
|
|---|---|---|---|
|
Clinical Global Impression of Change (CGI-C) Cataplexy
Much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Global Impression of Change (CGI-C) Cataplexy
Very much improved
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Clinical Global Impression of Change (CGI-C) Cataplexy
Much improved
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Global Impression of Change (CGI-C) Cataplexy
Minimally improved
|
6 Participants
|
7 Participants
|
7 Participants
|
|
Clinical Global Impression of Change (CGI-C) Cataplexy
No change
|
29 Participants
|
32 Participants
|
33 Participants
|
|
Clinical Global Impression of Change (CGI-C) Cataplexy
Minimally worse
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Global Impression of Change (CGI-C) Cataplexy
very much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 days after the end of treatment period IPopulation: mITT
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
Outcome measures
| Measure |
Modafinil + Placebo
n=48 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=47 Participants
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
|
THN102 300/27
n=47 Participants
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
|
|---|---|---|---|
|
Clinical Global Impression for Severity (CGI-S) Global Score
normal, not ill at all
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Global Score
borderline ill
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Global Score
mildly ill
|
11 Participants
|
8 Participants
|
11 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Global Score
moderately ill
|
13 Participants
|
18 Participants
|
14 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Global Score
markedly ill
|
14 Participants
|
8 Participants
|
5 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Global Score
severely ill
|
3 Participants
|
9 Participants
|
8 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Global Score
among the most extremely ill
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 14 days after the end of treatment period IPopulation: modified Intent To Treat : mITT
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
Outcome measures
| Measure |
Modafinil + Placebo
n=48 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=47 Participants
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
|
THN102 300/27
n=47 Participants
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
|
|---|---|---|---|
|
Clinical Global Impression for Severity (CGI-S) Sleepiness
Normal, not ill at all
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Sleepiness
Borderline ill
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Sleepiness
Mildly ill
|
9 Participants
|
8 Participants
|
10 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Sleepiness
Moderately ill
|
10 Participants
|
17 Participants
|
12 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Sleepiness
Markedly ill
|
16 Participants
|
10 Participants
|
8 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Sleepiness
Severely ill
|
5 Participants
|
9 Participants
|
9 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Sleepiness
Among the most extremely ill patients
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 14 days after the end of treatment period IPopulation: modified Intent To Treat : mITT
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
Outcome measures
| Measure |
Modafinil + Placebo
n=41 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=41 Participants
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
|
THN102 300/27
n=41 Participants
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
|
|---|---|---|---|
|
Clinical Global Impression for Severity (CGI-S) Cataplexy
Normal, not ill at all
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Cataplexy
Borderline ill
|
7 Participants
|
8 Participants
|
14 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Cataplexy
Mildly ill
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Cataplexy
Moderately ill
|
10 Participants
|
8 Participants
|
6 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Cataplexy
Markedly ill
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Cataplexy
Severely ill
|
2 Participants
|
3 Participants
|
6 Participants
|
|
Clinical Global Impression for Severity (CGI-S) Cataplexy
Among the most extremely ill patients
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: mITT
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
Outcome measures
| Measure |
Modafinil + Placebo
n=47 Participants
3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks
Active comparator: Modafinil + placebo
|
THN102 300/3
n=46 Participants
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
|
THN102 300/27
n=46 Participants
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
|
|---|---|---|---|
|
EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)
|
70.10 units on a scale
Standard Error 2.600
|
66.13 units on a scale
Standard Error 2.601
|
66.72 units on a scale
Standard Error 2.600
|
Adverse Events
THN102 300/0
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
THN102 300/3
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
THN102 300/27
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
THN102 300/0
n=48 participants at risk
Treatment A : THN102 300/0 Modafinil 300 mg/d Flecainide placebo
Duration : 2 weeks
|
THN102 300/3
n=47 participants at risk；n=48 participants at risk
Treatment B : THN102 300/3 Modafinil 300 mg/d Flecainide 3 mg/d Duration : 2 weeks
|
THN102 300/27
n=47 participants at risk；n=48 participants at risk
Treatment C : THN102 300/27 Modafinil 300 mg/d Flecainide 27 mg/d Duration : 2 weeks
|
|---|---|---|---|
|
Infections and infestations
tracheitis
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Infections and infestations
urinary tact infection
|
2.1%
1/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Injury, poisoning and procedural complications
limb injury
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Investigations
hepatic enzyme increase
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Metabolism and nutrition disorders
pain in extremity
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Nervous system disorders
balance disorder
|
2.1%
1/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Nervous system disorders
dizziness
|
2.1%
1/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
4.3%
2/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Nervous system disorders
headache
|
4.2%
2/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
4.3%
2/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Psychiatric disorders
irritability
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Psychiatric disorders
nightmare
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Psychiatric disorders
violence related symptom
|
2.1%
1/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
2.1%
1/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis allergic
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
2.1%
1/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.1%
1/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Cardiac disorders
Palpitation
|
2.1%
1/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Eye disorders
chalazion
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Gastrointestinal disorders
toothache
|
2.1%
1/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
General disorders
asthenia
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
General disorders
fatigue
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
General disorders
hunger
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
General disorders
sluggishness
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Immune system disorders
food allergy
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
4.3%
2/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Infections and infestations
influenza
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
4.3%
2/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Infections and infestations
laryngitis
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
2.1%
1/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
0.00%
0/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/48 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
4.3%
2/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
4.3%
2/47 • Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60