Trial Outcomes & Findings for NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT01654250)

Last Updated: 2016-02-03

Results Overview

The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

90 participants

Primary outcome timeframe

0.75 up to 13 hours post-dose

Results posted on

2016-02-03

Participant Flow

Total 90 participants were enrolled in this study, out of which 86 participants were randomized.

The study consisted of an open-label (OL) dose-optimization phase (1 to 6 weeks), and a placebo-controlled, double blind (DB) for 1 week with no dose adjustments.

Participant milestones

Participant milestones
Measure	Placebo (OL Phase; DB Phase) Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
Overall Study STARTED	44	42
Overall Study COMPLETED	43	42
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (OL Phase; DB Phase) Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (OL Phase; DB Phase) n=43 Participants Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) n=42 Participants NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	Total n=85 Participants Total of all reporting groups
Age, Continuous	9.3 years STANDARD_DEVIATION 1.62 • n=5 Participants	9.9 years STANDARD_DEVIATION 1.71 • n=7 Participants	9.6 years STANDARD_DEVIATION 1.69 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	30 Participants n=7 Participants	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0.75 up to 13 hours post-dose

Population: ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.

Outcome measures

Outcome measures
Measure	Placebo (OL Phase; DB Phase) n=43 Participants Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) n=42 Participants NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points	19.1 units on a scale Standard Error 1.39	12.1 units on a scale Standard Error 1.41

SECONDARY outcome

Timeframe: 0.75, 2, 4, 8, 10, 12, 13 hours post-dose

Onset and duration of clinical effect was determined using SKAMP combined rating scale at each post-dose time point. Onset of effect was defined as first assessment time showing statistical significance (i.e. p was less than or equal to \[=\<\] 0.05) between NWP09 and placebo and duration of effect was defined as the as last consecutive time-point at which difference was statistically significant between NWP09 and placebo. SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score was comprised of 13 items \[subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)\]. SKAMP combined score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.

Outcome measures

Outcome measures
Measure	Placebo (OL Phase; DB Phase) n=43 Participants Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) n=42 Participants NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
Onset and Duration of Clinical Effect Hour 0.75	18.3 Units on a scale Standard Deviation 11.21	10.7 Units on a scale Standard Deviation 9.79
Onset and Duration of Clinical Effect Hour 2	20.3 Units on a scale Standard Deviation 13.11	8.0 Units on a scale Standard Deviation 6.88
Onset and Duration of Clinical Effect Hour 4	19.8 Units on a scale Standard Deviation 12.99	8.1 Units on a scale Standard Deviation 6.74
Onset and Duration of Clinical Effect Hour 8	19.3 Units on a scale Standard Deviation 11.34	12.1 Units on a scale Standard Deviation 10.38
Onset and Duration of Clinical Effect Hour 10	17.7 Units on a scale Standard Deviation 11.58	14.8 Units on a scale Standard Deviation 10.26
Onset and Duration of Clinical Effect Hour 12	19.4 Units on a scale Standard Deviation 11.23	17.0 Units on a scale Standard Deviation 12.79
Onset and Duration of Clinical Effect Hour 13	18.4 Units on a scale Standard Deviation 10.73	17.5 Units on a scale Standard Deviation 13.38

SECONDARY outcome

Timeframe: 0.75, 2, 4, 8, 10, 12, 13 hours post-dose

SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. The SKAMP subscales were obtained by summing the individual items as follows: Attention (items 1-4) and Deportment (items 5-8), where each item was rated on a 7-point scale (0=normal to 6=maximal impairment). SKAMP attention subscale was reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment. SKAMP deportment subscale was reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.

Outcome measures

Outcome measures
Measure	Placebo (OL Phase; DB Phase) n=43 Participants Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) n=42 Participants NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 0.75: Attention Subscale	2.9 Units on a scale Standard Deviation 2.72	1.6 Units on a scale Standard Deviation 2.35
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 0.75: Deportment Subscale	4.6 Units on a scale Standard Deviation 4.91	2.1 Units on a scale Standard Deviation 3.74
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 2: Attention Subscale	3.4 Units on a scale Standard Deviation 3.27	1.1 Units on a scale Standard Deviation 1.85
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 2: Deportment Subscale	5.4 Units on a scale Standard Deviation 5.31	1.6 Units on a scale Standard Deviation 2.43
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 4: Attention Subscale	3.2 Units on a scale Standard Deviation 2.92	1.0 Units on a scale Standard Deviation 1.48
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 4: Deportment Subscale	5.4 Units on a scale Standard Deviation 5.22	1.7 Units on a scale Standard Deviation 3.29
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 8: Attention Subscale	3.5 Units on a scale Standard Deviation 2.92	2.0 Units on a scale Standard Deviation 2.82
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 8: Deportment Subscale	4.3 Units on a scale Standard Deviation 4.73	2.6 Units on a scale Standard Deviation 4.33
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 10: Attention Subscale	3.4 Units on a scale Standard Deviation 2.70	2.6 Units on a scale Standard Deviation 3.49
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 10: Deportment Subscale	3.9 Units on a scale Standard Deviation 4.86	2.6 Units on a scale Standard Deviation 3.18
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 12: Attention Subscale	3.4 Units on a scale Standard Deviation 2.91	3.2 Units on a scale Standard Deviation 3.26
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 12: Deportment Subscale	4.2 Units on a scale Standard Deviation 4.46	3.5 Units on a scale Standard Deviation 5.48
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 13: Attention Subscale	3.8 Units on a scale Standard Deviation 3.15	3.2 Units on a scale Standard Deviation 3.35
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 13: Deportment Subscale	3.7 Units on a scale Standard Deviation 4.30	3.9 Units on a scale Standard Deviation 5.48

SECONDARY outcome

Timeframe: 0.75, 2, 4, 8, 10, 12 and 13 post-dose

The PERMP score measured the manifestations of attention deficit hyperactivity disorder. The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10- minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure participant's performance. The total score range from 0-160 with higher scores indicating better performance.

Outcome measures

Outcome measures
Measure	Placebo (OL Phase; DB Phase) n=43 Participants Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) n=42 Participants NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 0.75: Problems attempted	105.4 Units on a scale Standard Deviation 51.08	128.8 Units on a scale Standard Deviation 53.32
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 0.75: Problems corrected	102.8 Units on a scale Standard Deviation 51.62	123.9 Units on a scale Standard Deviation 55.11
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 2: Problems attempted	106.6 Units on a scale Standard Deviation 55.22	140.9 Units on a scale Standard Deviation 57.85
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 2: Problems corrected	103.7 Units on a scale Standard Deviation 55.75	136.6 Units on a scale Standard Deviation 60.34
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 4: Problems attempted	107.2 Units on a scale Standard Deviation 55.89	140.0 Units on a scale Standard Deviation 62.88
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 4: Problems corrected	104.2 Units on a scale Standard Deviation 56.72	135.6 Units on a scale Standard Deviation 64.53
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 8: Problems attempted	101.7 Units on a scale Standard Deviation 53.32	129.1 Units on a scale Standard Deviation 62.64
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 8: Problems corrected	98.5 Units on a scale Standard Deviation 53.71	124.0 Units on a scale Standard Deviation 63.92
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 10: Problems attempted	103.2 Units on a scale Standard Deviation 53.54	113.9 Units on a scale Standard Deviation 62.33
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 10: Problems corrected	100.8 Units on a scale Standard Deviation 53.99	107.9 Units on a scale Standard Deviation 63.08
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 12: Problems attempted	97.9 Units on a scale Standard Deviation 48.86	111.1 Units on a scale Standard Deviation 55.70
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 12: Problems corrected	95.1 Units on a scale Standard Deviation 49.25	103.3 Units on a scale Standard Deviation 57.76
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 13: Problems attempted	98.6 Units on a scale Standard Deviation 46.01	115.4 Units on a scale Standard Deviation 57.30
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose Hour 13: Problems corrected	95.0 Units on a scale Standard Deviation 45.76	101.8 Units on a scale Standard Deviation 58.94

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 8, 15, 22, 29, 36, 43

CGI-S scale was used to measure features associated with ADHD. The assessment was performed by the investigator of the study research team. The CGI-S classified the participant's current disease status as: 1 = normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill participants. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.

Outcome measures

Outcome measures
Measure	Placebo (OL Phase; DB Phase) n=85 Participants Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
Clinical Global Impression of Severity (CGI-S) Baseline	4.6 Units on a scale Standard Deviation 0.66	—
Clinical Global Impression of Severity (CGI-S) Day 8	3.9 Units on a scale Standard Deviation 1.29	—
Clinical Global Impression of Severity (CGI-S) Day 15	3.3 Units on a scale Standard Deviation 1.16	—
Clinical Global Impression of Severity (CGI-S) Day 22	2.6 Units on a scale Standard Deviation 1.05	—
Clinical Global Impression of Severity (CGI-S) Day 29	2.2 Units on a scale Standard Deviation 1.02	—
Clinical Global Impression of Severity (CGI-S) Day 36	2.0 Units on a scale Standard Deviation 0.82	—
Clinical Global Impression of Severity (CGI-S) Day 43	2.0 Units on a scale Standard Deviation 0.89	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 8, 15, 22, 29, 36, 43

The CGI-I measured the participant's disease improvement relative to baseline as followed: 1= very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.

Outcome measures

Outcome measures
Measure	Placebo (OL Phase; DB Phase) n=85 Participants Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
Clinical Global Impression-Improvement (CGI-I) Day 15	2.3 Units on a scale Standard Deviation 0.94	—
Clinical Global Impression-Improvement (CGI-I) Day 8	3.0 Units on a scale Standard Deviation 1.07	—
Clinical Global Impression-Improvement (CGI-I) Day 22	1.7 Units on a scale Standard Deviation 0.69	—
Clinical Global Impression-Improvement (CGI-I) Day 29	1.4 Units on a scale Standard Deviation 0.56	—
Clinical Global Impression-Improvement (CGI-I) Day 36	1.3 Units on a scale Standard Deviation 0.49	—
Clinical Global Impression-Improvement (CGI-I) Day 43	1.3 Units on a scale Standard Deviation 0.46	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 8, 15, 22, 29, 36, 43

CPRS was used to measure features associated with ADHD and was used to compare scores during the dose optimization period i.e. 1-6 weeks. The assessment was performed by parent or guardian. CPRS consisted of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). Raw scores were converted to t-scores and t-scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. The participant received normalized t-scores on the following scales: oppositional, cognitive problems/inattention, hyperactivity, anxious-shy, perfectionism, social problems, psychosomatic, ADHD index, restless-impulse, emotional liability, conner's global index, inattentive, hyperactive-impulsive and diagnostic and statistical manual of mental disorders IV (DSM-IV). This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.

Outcome measures

Outcome measures
Measure	Placebo (OL Phase; DB Phase) n=85 Participants Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
Conners Parent Rating Scale (CPRS) Scores Oppositional : Baseline	67.3 Units on a scale Standard Deviation 15.08	—
Conners Parent Rating Scale (CPRS) Scores Cognitive Problems/ Inattention: Baseline	71.1 Units on a scale Standard Deviation 13.30	—
Conners Parent Rating Scale (CPRS) Scores Hyperactivity: Baseline	79.3 Units on a scale Standard Deviation 16.18	—
Conners Parent Rating Scale (CPRS) Scores Anxious-shy: Baseline	57.3 Units on a scale Standard Deviation 15.06	—
Conners Parent Rating Scale (CPRS) Scores Perfectionism: Baseline	54.9 Units on a scale Standard Deviation 12.75	—
Conners Parent Rating Scale (CPRS) Scores Social problems: Baseline	57.1 Units on a scale Standard Deviation 14.31	—
Conners Parent Rating Scale (CPRS) Scores Psychosomatic: Baseline	57.1 Units on a scale Standard Deviation 17.63	—
Conners Parent Rating Scale (CPRS) Scores ADHD index: Baseline	73.8 Units on a scale Standard Deviation 11.00	—
Conners Parent Rating Scale (CPRS) Scores Restless-Impulse: Baseline	74.6 Units on a scale Standard Deviation 12.48	—
Conners Parent Rating Scale (CPRS) Scores Emotional Liability: Baseline	64.8 Units on a scale Standard Deviation 15.82	—
Conners Parent Rating Scale (CPRS) Scores Conner's Global index: Baseline	73.6 Units on a scale Standard Deviation 13.25	—
Conners Parent Rating Scale (CPRS) Scores Inattentive: Baseline	73.8 Units on a scale Standard Deviation 12.57	—
Conners Parent Rating Scale (CPRS) Scores Hyperactive-Impulsive: Baseline	78.0 Units on a scale Standard Deviation 14.43	—
Conners Parent Rating Scale (CPRS) Scores DSM-IV: Baseline	77.8 Units on a scale Standard Deviation 12.04	—
Conners Parent Rating Scale (CPRS) Scores Oppositional: Day 8	64.0 Units on a scale Standard Deviation 15.89	—
Conners Parent Rating Scale (CPRS) Scores Cognitive Problems/ Inattention: Day 8	66.5 Units on a scale Standard Deviation 13.33	—
Conners Parent Rating Scale (CPRS) Scores Hyperactivity: Day 8	73.5 Units on a scale Standard Deviation 17.81	—
Conners Parent Rating Scale (CPRS) Scores Anxious-shy: Day 8	54.9 Units on a scale Standard Deviation 13.99	—
Conners Parent Rating Scale (CPRS) Scores Perfectionism: Day 8	52.7 Units on a scale Standard Deviation 11.80	—
Conners Parent Rating Scale (CPRS) Scores Social problems: Day 8	55.5 Units on a scale Standard Deviation 13.06	—
Conners Parent Rating Scale (CPRS) Scores Psychosomatic: Day 8	55.2 Units on a scale Standard Deviation 17.22	—
Conners Parent Rating Scale (CPRS) Scores ADHD index: Day 8	68.8 Units on a scale Standard Deviation 13.30	—
Conners Parent Rating Scale (CPRS) Scores Restless-Impulse: Day 8	69.7 Units on a scale Standard Deviation 14.51	—
Conners Parent Rating Scale (CPRS) Scores Emotional Liability: Day 8	62.1 Units on a scale Standard Deviation 15.25	—
Conners Parent Rating Scale (CPRS) Scores Conner's Global index: Day 8	68.9 Units on a scale Standard Deviation 15.06	—
Conners Parent Rating Scale (CPRS) Scores Inattentive: Day 8	68.3 Units on a scale Standard Deviation 13.46	—
Conners Parent Rating Scale (CPRS) Scores Hyperactive-Impulsive: Day 8	73.1 Units on a scale Standard Deviation 16.24	—
Conners Parent Rating Scale (CPRS) Scores DSM-IV: Day 8	72.1 Units on a scale Standard Deviation 14.62	—
Conners Parent Rating Scale (CPRS) Scores Oppositional: Day 15	59.5 Units on a scale Standard Deviation 14.75	—
Conners Parent Rating Scale (CPRS) Scores Cognitive Problems/ Inattention: Day 15	61.8 Units on a scale Standard Deviation 12.88	—
Conners Parent Rating Scale (CPRS) Scores Hyperactivity: Day 15	68.0 Units on a scale Standard Deviation 17.58	—
Conners Parent Rating Scale (CPRS) Scores Anxious-shy: Day 15	52.5 Units on a scale Standard Deviation 13.55	—
Conners Parent Rating Scale (CPRS) Scores Perfectionism: Day 15	51.1 Units on a scale Standard Deviation 11.51	—
Conners Parent Rating Scale (CPRS) Scores Social problems: Day 15	54.0 Units on a scale Standard Deviation 12.71	—
Conners Parent Rating Scale (CPRS) Scores Psychosomatic: Day 15	53.2 Units on a scale Standard Deviation 15.93	—
Conners Parent Rating Scale (CPRS) Scores ADHD index: Day 15	63.3 Units on a scale Standard Deviation 12.70	—
Conners Parent Rating Scale (CPRS) Scores Restless-Impulse: Day 15	65.2 Units on a scale Standard Deviation 13.96	—
Conners Parent Rating Scale (CPRS) Scores Emotional Liability: Day 15	57.0 Units on a scale Standard Deviation 13.84	—
Conners Parent Rating Scale (CPRS) Scores Conner's Global index: Day 15	63.6 Units on a scale Standard Deviation 14.08	—
Conners Parent Rating Scale (CPRS) Scores Inattentive: Day 15	63.0 Units on a scale Standard Deviation 13.39	—
Conners Parent Rating Scale (CPRS) Scores Hyperactive-Impulsive: Day 15	67.4 Units on a scale Standard Deviation 15.86	—
Conners Parent Rating Scale (CPRS) Scores DSM-IV: Day 15	66.2 Units on a scale Standard Deviation 14.33	—
Conners Parent Rating Scale (CPRS) Scores Oppositional: Day 22	55.5 Units on a scale Standard Deviation 13.27	—
Conners Parent Rating Scale (CPRS) Scores Cognitive Problems/ Inattention: Day 22	59.1 Units on a scale Standard Deviation 12.30	—
Conners Parent Rating Scale (CPRS) Scores Hyperactivity: Day 22	62.8 Units on a scale Standard Deviation 14.73	—
Conners Parent Rating Scale (CPRS) Scores Anxious-shy: Day 22	50.5 Units on a scale Standard Deviation 12.66	—
Conners Parent Rating Scale (CPRS) Scores Perfectionism: Day 22	49.3 Units on a scale Standard Deviation 10.08	—
Conners Parent Rating Scale (CPRS) Scores Social problems: Day 22	52.6 Units on a scale Standard Deviation 12.65	—
Conners Parent Rating Scale (CPRS) Scores Psychosomatic: Day 22	50.6 Units on a scale Standard Deviation 14.54	—
Conners Parent Rating Scale (CPRS) Scores ADHD index: Day 22	59.7 Units on a scale Standard Deviation 12.18	—
Conners Parent Rating Scale (CPRS) Scores Restless-Impulse: Day 22	59.6 Units on a scale Standard Deviation 12.86	—
Conners Parent Rating Scale (CPRS) Scores Emotional Liability: Day 22	53.3 Units on a scale Standard Deviation 12.60	—
Conners Parent Rating Scale (CPRS) Scores Conner's Global index: Day 22	58.4 Units on a scale Standard Deviation 13.17	—
Conners Parent Rating Scale (CPRS) Scores Inattentive: Day 22	59.5 Units on a scale Standard Deviation 12.44	—
Conners Parent Rating Scale (CPRS) Scores Hyperactive-Impulsive: Day 22	63.5 Units on a scale Standard Deviation 14.48	—
Conners Parent Rating Scale (CPRS) Scores DSM-IV: Day 22	62.3 Units on a scale Standard Deviation 13.30	—
Conners Parent Rating Scale (CPRS) Scores Oppositional: Day 29	52.8 Units on a scale Standard Deviation 11.28	—
Conners Parent Rating Scale (CPRS) Scores Cognitive Problems/ Inattention: Day 29	55.7 Units on a scale Standard Deviation 10.97	—
Conners Parent Rating Scale (CPRS) Scores Hyperactivity: Day 29	58.2 Units on a scale Standard Deviation 12.87	—
Conners Parent Rating Scale (CPRS) Scores Anxious-shy: Day 29	49.8 Units on a scale Standard Deviation 12.08	—
Conners Parent Rating Scale (CPRS) Scores Perfectionism: Day 29	48.3 Units on a scale Standard Deviation 9.63	—
Conners Parent Rating Scale (CPRS) Scores Social problems: Day 29	51.2 Units on a scale Standard Deviation 10.40	—
Conners Parent Rating Scale (CPRS) Scores Psychosomatic: Day 29	49.7 Units on a scale Standard Deviation 12.13	—
Conners Parent Rating Scale (CPRS) Scores ADHD index: Day 29	55.7 Units on a scale Standard Deviation 9.88	—
Conners Parent Rating Scale (CPRS) Scores Restless-Impulse: Day 29	55.9 Units on a scale Standard Deviation 10.77	—
Conners Parent Rating Scale (CPRS) Scores Emotional Liability: Day 29	51.0 Units on a scale Standard Deviation 10.29	—
Conners Parent Rating Scale (CPRS) Scores Conner's Global index: Day 29	54.8 Units on a scale Standard Deviation 10.88	—
Conners Parent Rating Scale (CPRS) Scores Inattentive: Day 29	55.6 Units on a scale Standard Deviation 11.19	—
Conners Parent Rating Scale (CPRS) Scores Hyperactive-Impulsive: Day 29	57.8 Units on a scale Standard Deviation 12.08	—
Conners Parent Rating Scale (CPRS) Scores DSM-IV: Day 29	57.1 Units on a scale Standard Deviation 11.10	—
Conners Parent Rating Scale (CPRS) Scores Oppositional: Day 36	50.5 Units on a scale Standard Deviation 10.42	—
Conners Parent Rating Scale (CPRS) Scores Cognitive Problems/ Inattention: Day 36	54.7 Units on a scale Standard Deviation 11.44	—
Conners Parent Rating Scale (CPRS) Scores Hyperactivity: Day 36	56.0 Units on a scale Standard Deviation 12.36	—
Conners Parent Rating Scale (CPRS) Scores Anxious-shy: Day 36	49.0 Units on a scale Standard Deviation 10.90	—
Conners Parent Rating Scale (CPRS) Scores Perfectionism: Day 36	46.6 Units on a scale Standard Deviation 8.08	—
Conners Parent Rating Scale (CPRS) Scores Social problems: Day 36	50.1 Units on a scale Standard Deviation 10.10	—
Conners Parent Rating Scale (CPRS) Scores Psychosomatic: Day 36	47.9 Units on a scale Standard Deviation 10.37	—
Conners Parent Rating Scale (CPRS) Scores ADHD index: Day 36	53.8 Units on a scale Standard Deviation 10.15	—
Conners Parent Rating Scale (CPRS) Scores Restless-Impulse: Day 36	54.3 Units on a scale Standard Deviation 10.79	—
Conners Parent Rating Scale (CPRS) Scores Emotional Liability: Day 36	49.8 Units on a scale Standard Deviation 9.76	—
Conners Parent Rating Scale (CPRS) Scores Conner's Global index: Day 36	53.3 Units on a scale Standard Deviation 10.90	—
Conners Parent Rating Scale (CPRS) Scores Inattentive: Day 36	54.7 Units on a scale Standard Deviation 11.49	—
Conners Parent Rating Scale (CPRS) Scores Hyperactive-Impulsive: Day 36	55.2 Units on a scale Standard Deviation 11.15	—
Conners Parent Rating Scale (CPRS) Scores DSM-IV: Day 36	55.4 Units on a scale Standard Deviation 10.96	—
Conners Parent Rating Scale (CPRS) Scores Oppositional: Day 43	49.8 Units on a scale Standard Deviation 10.81	—
Conners Parent Rating Scale (CPRS) Scores Cognitive Problems/ Inattention: Day 43	54.0 Units on a scale Standard Deviation 11.48	—
Conners Parent Rating Scale (CPRS) Scores Hyperactivity: Day 43	54.4 Units on a scale Standard Deviation 10.63	—
Conners Parent Rating Scale (CPRS) Scores Anxious-shy: Day 43	47.9 Units on a scale Standard Deviation 10.80	—
Conners Parent Rating Scale (CPRS) Scores Perfectionism: Day 43	45.9 Units on a scale Standard Deviation 7.60	—
Conners Parent Rating Scale (CPRS) Scores Social problems: Day 43	50.5 Units on a scale Standard Deviation 10.77	—
Conners Parent Rating Scale (CPRS) Scores Psychosomatic: Day 43	47.2 Units on a scale Standard Deviation 9.87	—
Conners Parent Rating Scale (CPRS) Scores ADHD index: Day 43	52.9 Units on a scale Standard Deviation 9.84	—
Conners Parent Rating Scale (CPRS) Scores Restless-Impulse: Day 43	53.2 Units on a scale Standard Deviation 10.37	—
Conners Parent Rating Scale (CPRS) Scores Emotional Liability: Day 43	48.9 Units on a scale Standard Deviation 9.21	—
Conners Parent Rating Scale (CPRS) Scores Conner's Global index: Day 43	52.1 Units on a scale Standard Deviation 10.16	—
Conners Parent Rating Scale (CPRS) Scores Inattentive: Day 43	53.8 Units on a scale Standard Deviation 11.14	—
Conners Parent Rating Scale (CPRS) Scores Hyperactive-Impulsive: Day 43	54.3 Units on a scale Standard Deviation 10.30	—
Conners Parent Rating Scale (CPRS) Scores DSM-IV: Day 43	54.3 Units on a scale Standard Deviation 10.74	—

Adverse Events

Placebo (OL Phase; DB Phase)

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

NWP09 (OL Phase; DB Phase)

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Placebo (OL Phase; DB Phase) n=44 participants at risk Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \[mg\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.	NWP09 (OL Phase; DB Phase) n=42 participants at risk NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
Metabolism and nutrition disorders Decreased appetite	38.6% 17/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	35.7% 15/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Increased appetite	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Mood swings	9.1% 4/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	19.0% 8/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	15.9% 7/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 2/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Initial insomnia	6.8% 3/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 2/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Middle insomnia	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Aggression	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anger	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Change in sustained attention	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Emotional poverty	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Onychophagia	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	15.9% 7/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.9% 5/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	9.1% 4/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 3/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 2/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Flatulence	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingival pain	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	15.9% 7/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 7/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 3/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	4.5% 2/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Otitis media	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Streptococcal impetigo	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Tic	4.5% 2/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	13.6% 6/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 3/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	9.1% 4/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 3/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 2/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Lethargy	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Aphonia	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Psychomotor hyperactivity	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Tremor	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Irritability	13.6% 6/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.9% 5/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Feeling jittery	4.5% 2/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.4% 1/42 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.