Trial Outcomes & Findings for Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1) (NCT NCT02618408)

Last Updated: 2024-01-02

Results Overview

The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the Baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 6, inclusive) and baseline period (Day ≤1), respectively. The IA behavior frequency per 7 days is defined as (SUM/DAY) x 7, where SUM is the total of the IA behaviors reported in the subject IA diary, and DAY is the number of days with a non-missing IA score in the subject IA diary during the specified study period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

333 participants

Primary outcome timeframe

Daily measure from Visit 2 (Week-2) to Visit 6 (Week 5) for a total of 7 weeks

Results posted on

2024-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Subjects were treated with a Placebo Placebo	Low Dose SPN-810 (18 mg) Subjects were treated with a low dose SPN-810 (18 mg)	High Dose SPN-810 (36 mg) Subjects were treated with a high dose SPN-810 (36 mg)
Overall Study STARTED	130	65	138
Overall Study Intent-to-Treat	125	65	135
Overall Study Safety	126	65	137
Overall Study COMPLETED	114	58	101
Overall Study NOT COMPLETED	16	7	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Subjects were treated with a Placebo Placebo	Low Dose SPN-810 (18 mg) Subjects were treated with a low dose SPN-810 (18 mg)	High Dose SPN-810 (36 mg) Subjects were treated with a high dose SPN-810 (36 mg)
Overall Study Withdrawal by Subject	1	0	4
Overall Study Withdrawal By Parent/Guardian	5	3	9
Overall Study Lost to Follow-up	4	2	6
Overall Study Adverse Event	4	0	10
Overall Study Physician Decision	1	1	2
Overall Study Protocol Violation	1	1	2
Overall Study Other, Multiple Categories	0	0	4

Baseline Characteristics

Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose SPN-810 (18 mg) n=65 Participants Subjects treated with low dose of SPN-810	High Dose SPN-810 (36 mg) n=135 Participants Subjects treated with high dose of SPN-810	Total n=325 Participants Total of all reporting groups	Placebo n=125 Participants Subjects treated with a Placebo
Age, Continuous	9.1 years STANDARD_DEVIATION 1.65 • n=7 Participants	9.1 years STANDARD_DEVIATION 1.84 • n=5 Participants	9.0 years STANDARD_DEVIATION 1.84 • n=4 Participants	8.9 years STANDARD_DEVIATION 1.95 • n=5 Participants
Sex: Female, Male Female	14 Participants n=7 Participants	34 Participants n=5 Participants	81 Participants n=4 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=7 Participants	101 Participants n=5 Participants	244 Participants n=4 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=7 Participants	19 Participants n=5 Participants	46 Participants n=4 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=7 Participants	116 Participants n=5 Participants	277 Participants n=4 Participants	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	26 Participants n=7 Participants	39 Participants n=5 Participants	86 Participants n=4 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized White	35 Participants n=7 Participants	85 Participants n=5 Participants	214 Participants n=4 Participants	94 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants	8 Participants n=5 Participants
Retrospective-Modified Overt Aggression Scale (R-MOAS)	73.82 units on a scale STANDARD_DEVIATION 37.552 • n=7 Participants	66.64 units on a scale STANDARD_DEVIATION 30.966 • n=5 Participants	69.25 units on a scale STANDARD_DEVIATION 33.257 • n=4 Participants	69.70 units on a scale STANDARD_DEVIATION 33.277 • n=5 Participants
Vitiello Aggression Scale	-3.57 units on a scale STANDARD_DEVIATION 1.145 • n=7 Participants	-3.42 units on a scale STANDARD_DEVIATION 1.018 • n=5 Participants	-3.54 units on a scale STANDARD_DEVIATION 1.055 • n=4 Participants	-3.65 units on a scale STANDARD_DEVIATION 1.042 • n=5 Participants

PRIMARY outcome

Timeframe: Daily measure from Visit 2 (Week-2) to Visit 6 (Week 5) for a total of 7 weeks

Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least 1 dose of the study drug and have a baseline and at least 1 valid post-randomization assessment of the frequency of IA behaviors based on IA diary entry.

Outcome measures

Outcome measures
Measure	Placebo n=125 Participants Subjects treated with a Placebo	Low Dose SPN-810 (18 mg) n=65 Participants Subjects treated with a low dose of SPN-810	High Dose SPN-810 (36 mg) n=135 Participants Subjects treated with a high dose of SPN-810
Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary	-48.16 percent change of IA behaviors Interval -100.0 to 98.3	-47.88 percent change of IA behaviors Interval -97.4 to 57.3	-58.56 percent change of IA behaviors Interval -100.0 to 140.5

SECONDARY outcome

Timeframe: Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks

The Clinical Global Impression - Improvement Scale (CGI-I) is an assessment of how much the patient's illness has improved or worsened relative to a baseline state at the beginning of treatment. CGI-I was evaluated by the Investigator at each visit on a 7-point scale with 1=very much improved, 2= much improved, 3= minimally improved, 4= no change, 5= minimally worse, 6= much worse, 7= very much worse

Outcome measures

Outcome measures
Measure	Placebo n=125 Participants Subjects treated with a Placebo	Low Dose SPN-810 (18 mg) n=65 Participants Subjects treated with a low dose of SPN-810	High Dose SPN-810 (36 mg) n=135 Participants Subjects treated with a high dose of SPN-810
Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated Visit 4	3.28 score on a scale Standard Deviation 0.829	3.14 score on a scale Standard Deviation 0.933	3.03 score on a scale Standard Deviation 0.867
Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated Visit 5	2.92 score on a scale Standard Deviation 0.935	2.81 score on a scale Standard Deviation 1.006	2.68 score on a scale Standard Deviation 0.970
Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated Visit 6	2.72 score on a scale Standard Deviation 0.979	2.58 score on a scale Standard Deviation 1.101	2.43 score on a scale Standard Deviation 0.983

SECONDARY outcome

Timeframe: Baseline/Visit 3 (Day 1), Visit 4 (Week 1), Visit 5 (Week 2), and Visit 6 (Week 5). The total duration of the study was 5 weeks.

The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors CGI-S was evaluated by the Investigator at each visit on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill Data represent the change between Baseline (Visit 3/Day 1) and three time points: Visit 4 (Week 1); Visit 5 (Week 2) and Visit 6 (Week 5).

Outcome measures

Outcome measures
Measure	Placebo n=125 Participants Subjects treated with a Placebo	Low Dose SPN-810 (18 mg) n=65 Participants Subjects treated with a low dose of SPN-810	High Dose SPN-810 (36 mg) n=135 Participants Subjects treated with a high dose of SPN-810
Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) Visit 4	-0.55 score on a scale Standard Deviation 0.772	-0.71 score on a scale Standard Deviation 0.964	-0.65 score on a scale Standard Deviation 0.928
Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) Visit 5	-0.88 score on a scale Standard Deviation 0.953	-1.08 score on a scale Standard Deviation 1.238	-1.08 score on a scale Standard Deviation 1.081
Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) Visit 6	-1.13 score on a scale Standard Deviation 1.106	-1.29 score on a scale Standard Deviation 1.325	-1.37 score on a scale Standard Deviation 1.080

SECONDARY outcome

Timeframe: Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.

CHQ-PF28) is a short generic measure of health status and health-related quality of life. The 28 items have 4, 5, or 6 response options, divided over 8 multi-item scales (physical functioning, general behavior, mental health, self-esteem, general health perceptions, parental impact: emotional, parental impact: time, and family activities) and 5 single item concepts (role functioning: emotional/behavior, role functioning: physical, bodily pain, family cohesion, and change in health). In addition, the individual scale scores will be aggregated to derive 2 summary component scores: the physical functioning and psychosocial health summary scores. The range on subscales and the overall scale is 0-100 (0 = worst possible health state; 100 = best possible health state). Data represent the change from Baseline (Visit 3) one time point, Visit 6 (Week 5).

Outcome measures

Outcome measures
Measure	Placebo n=125 Participants Subjects treated with a Placebo	Low Dose SPN-810 (18 mg) n=65 Participants Subjects treated with a low dose of SPN-810	High Dose SPN-810 (36 mg) n=135 Participants Subjects treated with a high dose of SPN-810
Effect of SPN-810 on Impulsive Aggression Measured by Child Health Questionnaire Parent Form 28-item (CHQ-PF28) Physical Functioning Summary Score At Visit 6	8.52 score on a scale Standard Deviation 10.786	10.11 score on a scale Standard Deviation 11.351	9.53 score on a scale Standard Deviation 11.199
Effect of SPN-810 on Impulsive Aggression Measured by Child Health Questionnaire Parent Form 28-item (CHQ-PF28) Psychosocial Health Summary Score At Visit 6	-0.99 score on a scale Standard Deviation 7.466	-2.66 score on a scale Standard Deviation 7.200	-2.09 score on a scale Standard Deviation 7.587

SECONDARY outcome

Timeframe: Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.

The PSI-4-SF is a 36-item self-report measure of parenting stress. Three subscales Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC) consist of 12 items each. Parent chooses one of the 5 responses against each item. The 5 responses are: Strongly Agree (SA), Agree (A), Not Sure (NS), Disagree (D), and Strongly Disagree (SD) to indicate the degree to which they agree with each statement. The PD subscale raw score ranges from 12-60, P-CDI and DC each subscale raw score ranges from 16-56. The total stress raw score is the sum of the three subscales (PD+P-CDI+ DC) with a minimum score of 44 and a maximum score of 172. The total stress score is then converted into the percentile score. Parents with a 91st percentile or higher are experiencing clinically significant levels of stress. Data represent the change between Baseline (Visit 3) and one time point, Visit 6 (Week 5).

Outcome measures

Outcome measures
Measure	Placebo n=125 Participants Subjects treated with a Placebo	Low Dose SPN-810 (18 mg) n=65 Participants Subjects treated with a low dose of SPN-810	High Dose SPN-810 (36 mg) n=135 Participants Subjects treated with a high dose of SPN-810
Effect of SPN-810 on Impulsive Aggression Measured by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF) Parental Distress Domain at Visit 6	-1.96 score on a scale Standard Deviation 7.049	-1.95 score on a scale Standard Deviation 6.163	-2.00 score on a scale Standard Deviation 7.319
Effect of SPN-810 on Impulsive Aggression Measured by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF) Difficult Child Domain at Visit 6	-4.21 score on a scale Standard Deviation 7.193	-2.14 score on a scale Standard Deviation 5.766	-3.72 score on a scale Standard Deviation 5.598
Effect of SPN-810 on Impulsive Aggression Measured by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF) Total Score at Visit 6	-8.95 score on a scale Standard Deviation 15.539	-5.52 score on a scale Standard Deviation 15.030	-8.40 score on a scale Standard Deviation 16.015
Effect of SPN-810 on Impulsive Aggression Measured by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF) Parent-Child Dysfunctional Interaction Domain at Visit 6	-2.94 score on a scale Standard Deviation 6.413	-1.43 score on a scale Standard Deviation 6.623	-2.69 score on a scale Standard Deviation 6.617

SECONDARY outcome

Timeframe: Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks]

The CGI scale was developed to provide a brief, stand-alone assessment of the clinician's view of a subject's global functioning prior to and after administration of a study medication. The scale was also rated by the caregiver to assess the improvement of IA behaviors. CGI-I was evaluated by the Caregiver at each visit on a 7-point scale with 1=very much improved, 2= much improved, 3= minimally improved, 4= no change, 5= minimally worse, 6= much worse, 7= very much worse

Outcome measures

Outcome measures
Measure	Placebo n=125 Participants Subjects treated with a Placebo	Low Dose SPN-810 (18 mg) n=65 Participants Subjects treated with a low dose of SPN-810	High Dose SPN-810 (36 mg) n=135 Participants Subjects treated with a high dose of SPN-810
Effect of SPN-810 on Impulsive Aggression Measured by the Caregiver Clinical Global Impression - Improvement Scale (CGI-I) Visit 4	3.11 score on a scale Standard Deviation 0.986	3.12 score on a scale Standard Deviation 1.008	2.91 score on a scale Standard Deviation 0.917
Effect of SPN-810 on Impulsive Aggression Measured by the Caregiver Clinical Global Impression - Improvement Scale (CGI-I) Visit 5	2.93 score on a scale Standard Deviation 0.967	2.76 score on a scale Standard Deviation 1.043	2.61 score on a scale Standard Deviation 1.087
Effect of SPN-810 on Impulsive Aggression Measured by the Caregiver Clinical Global Impression - Improvement Scale (CGI-I) Visit 6	2.66 score on a scale Standard Deviation 1.205	2.64 score on a scale Standard Deviation 1.210	2.29 score on a scale Standard Deviation 1.117

SECONDARY outcome

Timeframe: Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.

The Swanson, Nolan, Pelham Rating Scale-Revised (SNAP-IV) includes 18 ADHD and 8 oppositional defiant disorder (ODD) symptoms. The symptoms are scored on a 4-point scale. The ratings from the SNAP-IV scale are grouped into the following 4 subscales: ADHD Inattention (items #1-9), ADHD Hyperactivity/Impulsivity (items#10-18), ODD (items# 19-26), and ADHD-combined (first two scales combined, items #1-18). Each subscale score is the average rating of the items scores for the subscale. Therefore, for the inattention, the hyperactivity/impulsivity and the combined subscales the scores range from 0-27, while for the ODD scores range from 0-24; the higher is the score, worsen is the outcome. The following average cut-off are considered clinically significant based on the 95th percentile: 1.78 (Inattention items), 1.44 (hyperactivity/impulsivity items), 1.88 (ODD items) and 1.67 (combined type). Data represent the change between Baseline (Visit 3) and the end of the study, Visit 6 (Week 5).

Outcome measures

Outcome measures
Measure	Placebo n=125 Participants Subjects treated with a Placebo	Low Dose SPN-810 (18 mg) n=65 Participants Subjects treated with a low dose of SPN-810	High Dose SPN-810 (36 mg) n=135 Participants Subjects treated with a high dose of SPN-810
Effect of SPN-810 on Impulsive Aggression Measured by the Swanson, Nolan, Pelham Rating Scale- Revised (SNAP-IV) Rating Scale Inattention subscale	-0.45 score on a scale Standard Deviation 0.606	-0.50 score on a scale Standard Deviation 0.742	-0.53 score on a scale Standard Deviation 0.661
Effect of SPN-810 on Impulsive Aggression Measured by the Swanson, Nolan, Pelham Rating Scale- Revised (SNAP-IV) Rating Scale Hyperactivity/Impulsivity subscale	-0.43 score on a scale Standard Deviation 0.661	-0.50 score on a scale Standard Deviation 0.721	-0.59 score on a scale Standard Deviation 0.756
Effect of SPN-810 on Impulsive Aggression Measured by the Swanson, Nolan, Pelham Rating Scale- Revised (SNAP-IV) Rating Scale Oppositional Defiant Disorder subscale	-0.50 score on a scale Standard Deviation 0.698	-0.54 score on a scale Standard Deviation 0.833	-0.58 score on a scale Standard Deviation 0.838
Effect of SPN-810 on Impulsive Aggression Measured by the Swanson, Nolan, Pelham Rating Scale- Revised (SNAP-IV) Rating Scale Combined subscale	-0.44 score on a scale Standard Deviation 0.576	-0.50 score on a scale Standard Deviation 0.677	-0.56 score on a scale Standard Deviation 0.657

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Low Dose SPN-810 (18 mg)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

High Dose SPN-810 (36 mg)

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=126 participants at risk Subjects were treated with a Placebo	Low Dose SPN-810 (18 mg) n=65 participants at risk Subjects were treated with a low dose of SPN-810	High Dose SPN-810 (36 mg) n=137 participants at risk Subjects were treated with a high dose of SPN-810
Eye disorders Vision blurred	0.00% 0/126 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	0.00% 0/65 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	0.73% 1/137 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.
Infections and infestations Appendicitis Perforated	0.00% 0/126 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	0.00% 0/65 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	0.73% 1/137 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.

Other adverse events

Other adverse events
Measure	Placebo n=126 participants at risk Subjects were treated with a Placebo	Low Dose SPN-810 (18 mg) n=65 participants at risk Subjects were treated with a low dose of SPN-810	High Dose SPN-810 (36 mg) n=137 participants at risk Subjects were treated with a high dose of SPN-810
General disorders Fatigue	0.79% 1/126 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	3.1% 2/65 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	7.3% 10/137 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.
General disorders Headache	1.6% 2/126 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	3.1% 2/65 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	5.1% 7/137 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.
Metabolism and nutrition disorders Increased appetite	4.8% 6/126 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	0.00% 0/65 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	6.6% 9/137 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.
Investigations Blood prolactin Increased	0.79% 1/126 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	6.2% 4/65 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	1.5% 2/137 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.
Infections and infestations Upper respiratory tract infection	6.3% 8/126 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	3.1% 2/65 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.	1.5% 2/137 • Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.

Additional Information

Gianpiera Ceresoli-Borroni, PhD, Director of Clinical Research

Supernus

Phone: 301-838-2521

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER