Trial Outcomes & Findings for Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness (NCT NCT03624920)
NCT ID: NCT03624920
Last Updated: 2020-12-01
Results Overview
Number of participants with spontaneously reported treatment-related adverse events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
2 weeks
Results posted on
2020-12-01
Participant Flow
105 patients were screened and 77 were randomized and allowed to start the medications periods.
Participant milestones
| Measure |
Sequence ABC
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Sequence BCA
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Sequence CAB
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Sequence ACB
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Sequence CBA
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Sequence BAC
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
13
|
13
|
11
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
12
|
12
|
7
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
1
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Baseline characteristics by cohort
| Measure |
Sequence ABC
n=13 Participants
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Sequence BCA
n=13 Participants
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Sequence CAB
n=13 Participants
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Sequence ACB
n=13 Participants
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Sequence CBA
n=9 Participants
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Sequence BAC
n=11 Participants
A : 2 weeks under Placebo
B : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)
C : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
38 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race : White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
71 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Not hispanic or latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
69 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Overall number of participant reported corresponds to the safety set population of the clinical report
Number of participants with spontaneously reported treatment-related adverse events
Outcome measures
| Measure |
Placebo
n=68 Participants
THN102 Placebo (Dosage A)
|
THN102 200/2
n=72 Participants
THN102 200 mg/2 mg (Dosage B)
|
THN102 200/18
n=73 Participants
THN102 200 mg/18 mg (Dosage C)
|
|---|---|---|---|
|
Safety Adverse Events
Subjects with at least one TEAE leading to death
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Adverse Events
Subject with at least one serious TEAE
|
0 participants
|
0 participants
|
1 participants
|
|
Safety Adverse Events
Subjects with at least one related serious TEAE
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Adverse Events
Subjects with at least one TEAE
|
19 participants
|
23 participants
|
29 participants
|
|
Safety Adverse Events
Subjects with at least one related TEAE
|
5 participants
|
11 participants
|
18 participants
|
|
Safety Adverse Events
Subjects with at least one TEAE leading to discont
|
0 participants
|
3 participants
|
3 participants
|
|
Safety Adverse Events
Subjects with at least one related TEAE leading to
|
0 participants
|
2 participants
|
3 participants
|
|
Safety Adverse Events
Subjects with at least one serious TEAE leading to
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: modified intent to treat
Range of the scale : 0 to 24. A low score indicates a good outcome. Results shown are corresponding to a change from baseline of the ESS score.
Outcome measures
| Measure |
Placebo
n=68 Participants
THN102 Placebo (Dosage A)
|
THN102 200/2
n=70 Participants
THN102 200 mg/2 mg (Dosage B)
|
THN102 200/18
n=72 Participants
THN102 200 mg/18 mg (Dosage C)
|
|---|---|---|---|
|
Epworth Sleeping Scale (ESS)
|
-2.4422 score on a scale
Standard Error 0.5117
|
-3.8417 score on a scale
Standard Error 0.5086
|
-3.1850 score on a scale
Standard Error 0.4982
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: PVT full analysis set
PVT measures reaction time in milliseconds. The results below are corresponding to the reaction time change from baseline.
Outcome measures
| Measure |
Placebo
n=68 Participants
THN102 Placebo (Dosage A)
|
THN102 200/2
n=70 Participants
THN102 200 mg/2 mg (Dosage B)
|
THN102 200/18
n=72 Participants
THN102 200 mg/18 mg (Dosage C)
|
|---|---|---|---|
|
Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline
|
-21.2201 millisecond (msec)
Standard Error 10.0565
|
-24.1089 millisecond (msec)
Standard Error 9.9393
|
-19.6450 millisecond (msec)
Standard Error 9.8847
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: mITT
MoCA score reflects the cognitive capacities of a person. Range of the total score of 10 test items: 0 to 30 points. A high score indicates good cognitive functioning. A score of 26 and above is considered normal. The results below are shown as change from baseline of the MoCA score.
Outcome measures
| Measure |
Placebo
n=68 Participants
THN102 Placebo (Dosage A)
|
THN102 200/2
n=70 Participants
THN102 200 mg/2 mg (Dosage B)
|
THN102 200/18
n=72 Participants
THN102 200 mg/18 mg (Dosage C)
|
|---|---|---|---|
|
Montreal Cognitive Assessment Battery (MoCA)
|
0.2240 score on a scale
Standard Error 0.1935
|
0.03267 score on a scale
Standard Error 0.1923
|
0.4251 score on a scale
Standard Error 0.1900
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: mITT
ESS score responder rate, defined as the proportion of subjects with at least 25% ESS improvement from baseline, at the end of each treatment period
Outcome measures
| Measure |
Placebo
n=68 Participants
THN102 Placebo (Dosage A)
|
THN102 200/2
n=69 Participants
THN102 200 mg/2 mg (Dosage B)
|
THN102 200/18
n=71 Participants
THN102 200 mg/18 mg (Dosage C)
|
|---|---|---|---|
|
Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline
|
19 Participants
|
28 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: mITT
Number of patients in remission (=without residual sleepiness), i.e. ESS \< 11 at the end of each treatment period
Outcome measures
| Measure |
Placebo
n=68 Participants
THN102 Placebo (Dosage A)
|
THN102 200/2
n=69 Participants
THN102 200 mg/2 mg (Dosage B)
|
THN102 200/18
n=71 Participants
THN102 200 mg/18 mg (Dosage C)
|
|---|---|---|---|
|
Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline
|
11 Participants
|
19 Participants
|
18 Participants
|
Adverse Events
THN102 Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
THN102 200/2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
THN102 200/18
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
THN102 Placebo
n=68 participants at risk
THN102 Placebo (Dosage A)
|
THN102 200/2
n=72 participants at risk
THN102 200 mg/2 mg (Dosage B)
|
THN102 200/18
n=73 participants at risk
THN102 200 mg/18 mg (Dosage C)
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/68 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
0.00%
0/72 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
1.4%
1/73 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
Other adverse events
| Measure |
THN102 Placebo
n=68 participants at risk
THN102 Placebo (Dosage A)
|
THN102 200/2
n=72 participants at risk
THN102 200 mg/2 mg (Dosage B)
|
THN102 200/18
n=73 participants at risk
THN102 200 mg/18 mg (Dosage C)
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/68 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
2.8%
2/72 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
5.5%
4/73 • Number of events 4 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/68 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
1.4%
1/72 • Number of events 1 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
2.7%
2/73 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/68 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
0.00%
0/72 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
2.7%
2/73 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/68 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
0.00%
0/72 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
2.7%
2/73 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/68 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
2.8%
2/72 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
4.1%
3/73 • Number of events 3 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/68 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
0.00%
0/72 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
4.1%
3/73 • Number of events 3 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/68 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
1.4%
1/72 • Number of events 1 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
4.1%
3/73 • Number of events 3 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/68 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
2.8%
2/72 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
0.00%
0/73 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
|
General disorders
Fatigue
|
2.9%
2/68 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
0.00%
0/72 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
2.7%
2/73 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
|
General disorders
Chest pain
|
1.5%
1/68 • Number of events 1 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
2.8%
2/72 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
1.4%
1/73 • Number of events 2 • AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60