Trial Outcomes & Findings for Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems (NCT NCT00626236)

Last Updated: 2025-12-09

Results Overview

The Nisonger Child Behavior Rating Form (NCBRF) is an instrument designed to assess the behavior of children with intellectual or developmental disabilities. The NCBRF-TIQ is a 66-item behavior rating form designed to assess the behavior of children and adolescents with typical development. The NCBRF is made up of three sections: I, Where raters can identify unusual circumstances that may have affected the youth's behavior; II, where positive behaviors are rated, and III, a listing of problem behaviors. There are separate Teacher and Parent versions of the form, and the NCBRF takes about 15 minutes to complete. The NCBRF is designed to be used with children and adolescents ages 3 to 16 years. The lowest score is a "0" and the highest score is "198". A higher score of the Conduct Problem Subscale score means a worse outcome. A change or negative score means improvement. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Results posted on

2025-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment 1 5/10mg TDD SPN-810: capsule taken three times a day	Treatment 2 10/20mg TDD SPN-810: capsule taken TID	Treatment 3 15/30mg TDD SPN-810: capsule taken TID	Treatment 4 20/40mg TDD SPN-810: capsule taken TID
Overall Study STARTED	20	19	19	20
Overall Study COMPLETED	14	12	15	14
Overall Study NOT COMPLETED	6	7	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment 1 5/10mg TDD n=20 Participants SPN-810: capsule taken three times a day	Treatment 2 10/20mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 3 15/30mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 4 20/40mg TDD n=20 Participants SPN-810: capsule taken TID	Total n=78 Participants Total of all reporting groups
Age, Continuous	8.5 years STANDARD_DEVIATION 1.88 • n=4 Participants	9.4 years STANDARD_DEVIATION 1.98 • n=50 Participants	8.8 years STANDARD_DEVIATION 2.12 • n=518 Participants	8.8 years STANDARD_DEVIATION 2.00 • n=175 Participants	8.8 years STANDARD_DEVIATION 1.98 • n=700 Participants
Sex: Female, Male Female	1 Participants n=4 Participants	3 Participants n=50 Participants	6 Participants n=518 Participants	1 Participants n=175 Participants	11 Participants n=700 Participants
Sex: Female, Male Male	19 Participants n=4 Participants	16 Participants n=50 Participants	13 Participants n=518 Participants	19 Participants n=175 Participants	67 Participants n=700 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=4 Participants	0 Participants n=50 Participants	5 Participants n=518 Participants	1 Participants n=175 Participants	7 Participants n=700 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=4 Participants	19 Participants n=50 Participants	14 Participants n=518 Participants	19 Participants n=175 Participants	71 Participants n=700 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	0 Participants n=175 Participants	0 Participants n=700 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	0 Participants n=175 Participants	0 Participants n=700 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	0 Participants n=175 Participants	0 Participants n=700 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	0 Participants n=175 Participants	0 Participants n=700 Participants
Race (NIH/OMB) Black or African American	9 Participants n=4 Participants	8 Participants n=50 Participants	9 Participants n=518 Participants	7 Participants n=175 Participants	33 Participants n=700 Participants
Race (NIH/OMB) White	11 Participants n=4 Participants	11 Participants n=50 Participants	8 Participants n=518 Participants	13 Participants n=175 Participants	43 Participants n=700 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=50 Participants	2 Participants n=518 Participants	0 Participants n=175 Participants	2 Participants n=700 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants	0 Participants n=175 Participants	0 Participants n=700 Participants
Region of Enrollment United States	20 Participants n=4 Participants	19 Participants n=50 Participants	19 Participants n=518 Participants	20 Participants n=175 Participants	78 Participants n=700 Participants

PRIMARY outcome

Timeframe: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment

Outcome measures

Outcome measures
Measure	Treatment 1 5/10mg TDD n=20 Participants SPN-810: capsule taken three times a day	Treatment 2 10/20mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 3 15/30mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 4 20/40mg TDD n=20 Participants SPN-810: capsule taken TID
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 11 Change from Baseline	-7.9 score on a scale Standard Deviation 6.77	-9.9 score on a scale Standard Deviation 9.31	-9.2 score on a scale Standard Deviation 10.60	-14.5 score on a scale Standard Deviation 8.65
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 12 Change from Baseline	-7.0 score on a scale Standard Deviation 7.13	-8.7 score on a scale Standard Deviation 9.31	-8.2 score on a scale Standard Deviation 10.51	-14.3 score on a scale Standard Deviation 8.64
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Mean Score at Baseline	20.4 score on a scale Standard Deviation 5.22	25.7 score on a scale Standard Deviation 6.98	26.0 score on a scale Standard Deviation 5.51	26.0 score on a scale Standard Deviation 7.63
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 2 Change from Baseline	-0.6 score on a scale Standard Deviation 5.82	-3.3 score on a scale Standard Deviation 5.94	-2.6 score on a scale Standard Deviation 6.69	-3.3 score on a scale Standard Deviation 5.72
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 3 Change from Baseline	-0.6 score on a scale Standard Deviation 5.82	-7.1 score on a scale Standard Deviation 9.95	-3.4 score on a scale Standard Deviation 6.78	-6.1 score on a scale Standard Deviation 6.69
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 4 Change from Baseline	-0.6 score on a scale Standard Deviation 5.82	-7.1 score on a scale Standard Deviation 9.95	-5.0 score on a scale Standard Deviation 9.57	-8.9 score on a scale Standard Deviation 6.95
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 5 Change from Baseline	-0.6 score on a scale Standard Deviation 5.82	-7.1 score on a scale Standard Deviation 9.95	-5.0 score on a scale Standard Deviation 9.57	-11.7 score on a scale Standard Deviation 7.68
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 6 Change from Baseline	-2.7 score on a scale Standard Deviation 5.38	-7.8 score on a scale Standard Deviation 9.60	-6.4 score on a scale Standard Deviation 9.31	-11.6 score on a scale Standard Deviation 7.51
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 7 Change from Baseline	-4.8 score on a scale Standard Deviation 6.07	-8.1 score on a scale Standard Deviation 9.79	-7.6 score on a scale Standard Deviation 8.71	-12.9 score on a scale Standard Deviation 8.35
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 8 Change from Baseline	-6.0 score on a scale Standard Deviation 7.19	-7.6 score on a scale Standard Deviation 8.37	-9.0 score on a scale Standard Deviation 9.84	-14.5 score on a scale Standard Deviation 9.24
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 9 Change from Baseline	-8.1 score on a scale Standard Deviation 6.33	-7.8 score on a scale Standard Deviation 8.21	-9.7 score on a scale Standard Deviation 9.74	-14.8 score on a scale Standard Deviation 8.49
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score Visit 10 Change from Baseline	-7.9 score on a scale Standard Deviation 6.86	-7.9 score on a scale Standard Deviation 8.36	-11.2 score on a scale Standard Deviation 8.93	-13.6 score on a scale Standard Deviation 9.87

SECONDARY outcome

Timeframe: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment

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 the administration of study medication. The severity of illness (CGI-S) is rated by the investigator 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 from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). A lower overall score in subsequent testing indicates successful therapy.

Outcome measures

Outcome measures
Measure	Treatment 1 5/10mg TDD n=20 Participants SPN-810: capsule taken three times a day	Treatment 2 10/20mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 3 15/30mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 4 20/40mg TDD n=20 Participants SPN-810: capsule taken TID
The Changes From Baseline in the CGI-S Baseline Score	4.35 score on a scale Standard Deviation 0.587	4.74 score on a scale Standard Deviation 0.562	4.63 score on a scale Standard Deviation 0.684	4.70 score on a scale Standard Deviation 0.470
The Changes From Baseline in the CGI-S Visit 2 Change From Baseline	-0.20 score on a scale Standard Deviation 0.523	-0.26 score on a scale Standard Deviation 0.562	-0.11 score on a scale Standard Deviation 0.459	-0.20 score on a scale Standard Deviation 0.523
The Changes From Baseline in the CGI-S Visit 3 Change From Baseline	-0.20 score on a scale Standard Deviation 0.523	-0.47 score on a scale Standard Deviation 0.772	-0.37 score on a scale Standard Deviation 0.496	-0.45 score on a scale Standard Deviation 0.510
The Changes From Baseline in the CGI-S Visit 4 Change From Baseline	-0.20 score on a scale Standard Deviation 0.523	-0.47 score on a scale Standard Deviation 0.772	-0.63 score on a scale Standard Deviation 0.831	-0.75 score on a scale Standard Deviation 0.716
The Changes From Baseline in the CGI-S Visit 5 Change From Baseline	-0.20 score on a scale Standard Deviation 0.523	-0.47 score on a scale Standard Deviation 0.772	-0.63 score on a scale Standard Deviation 0.831	-1.10 score on a scale Standard Deviation 0.788
The Changes From Baseline in the CGI-S Visit 6 Change From Baseline	-0.20 score on a scale Standard Deviation 0.523	-0.68 score on a scale Standard Deviation 0.749	-0.89 score on a scale Standard Deviation 0.809	-1.30 score on a scale Standard Deviation 0.923
The Changes From Baseline in the CGI-S Visit 7 Change From Baseline	-0.55 score on a scale Standard Deviation 0.686	-0.79 score on a scale Standard Deviation 0.713	-1.26 score on a scale Standard Deviation 0.991	-1.30 score on a scale Standard Deviation 0.923
The Changes From Baseline in the CGI-S Visit 8 Change From Baseline	-0.85 score on a scale Standard Deviation 0.813	-0.79 score on a scale Standard Deviation 0.855	-1.37 score on a scale Standard Deviation 0.895	-1.50 score on a scale Standard Deviation 1.192
The Changes From Baseline in the CGI-S Visit 9 Change From Baseline	-1.05 score on a scale Standard Deviation 0.759	-0.89 score on a scale Standard Deviation 0.875	-1.32 score on a scale Standard Deviation 0.946	-1.70 score on a scale Standard Deviation 1.218
The Changes From Baseline in the CGI-S Visit 10 Change From Baseline	-1.10 score on a scale Standard Deviation 0.968	-0.84 score on a scale Standard Deviation 0.898	-1.53 score on a scale Standard Deviation 0.964	-1.65 score on a scale Standard Deviation 1.137
The Changes From Baseline in the CGI-S Visit 11 Change From Baseline	-1.15 score on a scale Standard Deviation 0.875	-1.05 score on a scale Standard Deviation 0.970	-1.37 score on a scale Standard Deviation 1.012	-1.55 score on a scale Standard Deviation 1.099
The Changes From Baseline in the CGI-S Visit 12 Change From Baseline	-1.00 score on a scale Standard Deviation 0.973	-1.00 score on a scale Standard Deviation 1.000	-1.26 score on a scale Standard Deviation 0.933	-1.75 score on a scale Standard Deviation 1.293

SECONDARY outcome

Timeframe: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment

Clinical Global Impression Scale. CGI-I is measured relative to the condition at the Baseline 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, and 7=Very much worse. A lower overall score in subsequential testing indicates successful treatment. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).

Outcome measures

Outcome measures
Measure	Treatment 1 5/10mg TDD n=20 Participants SPN-810: capsule taken three times a day	Treatment 2 10/20mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 3 15/30mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 4 20/40mg TDD n=20 Participants SPN-810: capsule taken TID
Clinical Global Impression - Improvement Scale (CGI-I) Visit 2 Change from Baseline	0.00 score on a scale Standard Deviation 0.0	0.00 score on a scale Standard Deviation 0.0	0.00 score on a scale Standard Deviation 0.0	0.00 score on a scale Standard Deviation 0.0
Clinical Global Impression - Improvement Scale (CGI-I) Visit 3 Change from Baseline	0.00 score on a scale Standard Deviation 0.000	-0.41 score on a scale Standard Deviation 0.795	-0.21 score on a scale Standard Deviation 0.631	-0.42 score on a scale Standard Deviation 0.961
Clinical Global Impression - Improvement Scale (CGI-I) Visit 4 Change from Baseline	0.00 score on a scale Standard Deviation 0.000	-0.41 score on a scale Standard Deviation 0.795	-0.58 score on a scale Standard Deviation 0.961	-0.68 score on a scale Standard Deviation 0.820
Clinical Global Impression - Improvement Scale (CGI-I) Visit 5 Change from Baseline	0.00 score on a scale Standard Deviation 0.000	-0.41 score on a scale Standard Deviation 0.795	-0.58 score on a scale Standard Deviation 0.961	-1.16 score on a scale Standard Deviation 1.167
Clinical Global Impression - Improvement Scale (CGI-I) Visit 6 Change from Baseline	-0.12 score on a scale Standard Deviation 0.697	-0.76 score on a scale Standard Deviation 0.903	-0.79 score on a scale Standard Deviation 0.918	-1.26 score on a scale Standard Deviation 1.046
Clinical Global Impression - Improvement Scale (CGI-I) Visit 7 Change from Baseline	-0.59 score on a scale Standard Deviation 0.939	-0.88 score on a scale Standard Deviation 1.111	-1.21 score on a scale Standard Deviation 0.918	-1.26 score on a scale Standard Deviation 1.046
Clinical Global Impression - Improvement Scale (CGI-I) Visit 8 Change from Baseline	-0.88 score on a scale Standard Deviation 0.928	-0.88 score on a scale Standard Deviation 1.219	-1.42 score on a scale Standard Deviation 1.017	-1.26 score on a scale Standard Deviation 1.098
Clinical Global Impression - Improvement Scale (CGI-I) Visit 9 Change from Baseline	-1.06 score on a scale Standard Deviation 0.827	-0.94 score on a scale Standard Deviation 1.144	-1.26 score on a scale Standard Deviation 0.933	-1.37 score on a scale Standard Deviation 1.012
Clinical Global Impression - Improvement Scale (CGI-I) Visit 10 Change from Baseline	-1.00 score on a scale Standard Deviation 1.118	-0.88 score on a scale Standard Deviation 1.317	-1.53 score on a scale Standard Deviation 1.073	-1.42 score on a scale Standard Deviation 1.017
Clinical Global Impression - Improvement Scale (CGI-I) Visit 11 Change from Baseline	-1.29 score on a scale Standard Deviation 0.985	-0.94 score on a scale Standard Deviation 1.435	-1.32 score on a scale Standard Deviation 1.003	-1.37 score on a scale Standard Deviation 1.012
Clinical Global Impression - Improvement Scale (CGI-I) Visit 12 Change from Baseline	-1.12 score on a scale Standard Deviation 1.219	-1.00 score on a scale Standard Deviation 1.000	-1.26 score on a scale Standard Deviation 0.872	-1.32 score on a scale Standard Deviation 1.057

SECONDARY outcome

Timeframe: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment

The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #0-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the inattention subscale, the scores range from 0-27, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.

Outcome measures

Outcome measures
Measure	Treatment 1 5/10mg TDD n=20 Participants SPN-810: capsule taken three times a day	Treatment 2 10/20mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 3 15/30mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 4 20/40mg TDD n=20 Participants SPN-810: capsule taken TID
SNAP-IV ADHD Inattention Baseline Score	18.20 score on a scale Standard Deviation 6.810	20.42 score on a scale Standard Deviation 4.501	20.00 score on a scale Standard Deviation 4.190	21.05 score on a scale Standard Deviation 4.211
SNAP-IV ADHD Inattention Visit 2 Change from Baseline	-1.55 score on a scale Standard Deviation 5.010	-1.74 score on a scale Standard Deviation 4.593	-1.84 score on a scale Standard Deviation 5.167	0.10 score on a scale Standard Deviation 5.200
SNAP-IV ADHD Inattention Visit 3 Change from Baseline	-1.55 score on a scale Standard Deviation 5.010	-3.79 score on a scale Standard Deviation 5.149	-3.84 score on a scale Standard Deviation 4.729	-1.35 score on a scale Standard Deviation 5.234
SNAP-IV ADHD Inattention Visit 4 Change from Baseline	-1.55 score on a scale Standard Deviation 5.010	-3.79 score on a scale Standard Deviation 5.149	-5.11 score on a scale Standard Deviation 5.517	-2.35 score on a scale Standard Deviation 5.770
SNAP-IV ADHD Inattention Visit 5 Change from Baseline	-1.55 score on a scale Standard Deviation 5.010	-3.79 score on a scale Standard Deviation 5.149	-5.11 score on a scale Standard Deviation 5.517	-5.30 score on a scale Standard Deviation 7.420
SNAP-IV ADHD Inattention Visit 6 Change from Baseline	-1.15 score on a scale Standard Deviation 5.556	-4.21 score on a scale Standard Deviation 5.583	-7.16 score on a scale Standard Deviation 4.752	-5.60 score on a scale Standard Deviation 5.888
SNAP-IV ADHD Inattention Visit 7 Change from Baseline	-2.55 score on a scale Standard Deviation 5.104	-5.84 score on a scale Standard Deviation 4.729	-6.42 score on a scale Standard Deviation 5.984	-6.00 score on a scale Standard Deviation 7.732
SNAP-IV ADHD Inattention Visit 8 Change from Baseline	-3.95 score on a scale Standard Deviation 6.126	-5.68 score on a scale Standard Deviation 5.197	-7.05 score on a scale Standard Deviation 6.302	-6.65 score on a scale Standard Deviation 7.088
SNAP-IV ADHD Inattention Visit 9 Change from Baseline	-5.65 score on a scale Standard Deviation 6.385	-4.42 score on a scale Standard Deviation 4.706	-7.05 score on a scale Standard Deviation 5.902	-8.30 score on a scale Standard Deviation 7.794
SNAP-IV ADHD Inattention Visit 10 Change from Baseline	-5.15 score on a scale Standard Deviation 7.206	-5.42 score on a scale Standard Deviation 4.834	-8.89 score on a scale Standard Deviation 6.341	-7.55 score on a scale Standard Deviation 8.733
SNAP-IV ADHD Inattention Visit 11 Change from Baseline	-5.65 score on a scale Standard Deviation 7.006	-5.63 score on a scale Standard Deviation 5.058	-8.11 score on a scale Standard Deviation 6.420	-8.20 score on a scale Standard Deviation 7.885
SNAP-IV ADHD Inattention Visit 12 Change from Baseline	-4.35 score on a scale Standard Deviation 6.150	-6.32 score on a scale Standard Deviation 5.558	-6.84 score on a scale Standard Deviation 5.956	-8.15 score on a scale Standard Deviation 7.611

SECONDARY outcome

Timeframe: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment

The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the Hyperactivity/Impulsivity subscale, the scores range from 0-27, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.

Outcome measures

Outcome measures
Measure	Treatment 1 5/10mg TDD n=20 Participants SPN-810: capsule taken three times a day	Treatment 2 10/20mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 3 15/30mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 4 20/40mg TDD n=20 Participants SPN-810: capsule taken TID
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Baseline Score	19.60 score on a scale Standard Deviation 5.933	21.74 score on a scale Standard Deviation 5.173	19.11 score on a scale Standard Deviation 5.517	20.95 score on a scale Standard Deviation 4.989
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 2 Change from Baseline	-0.90 score on a scale Standard Deviation 4.166	-1.47 score on a scale Standard Deviation 3.821	-1.42 score on a scale Standard Deviation 4.562	-1.05 score on a scale Standard Deviation 3.832
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 3 Change from Baseline	-0.90 score on a scale Standard Deviation 4.166	-3.32 score on a scale Standard Deviation 4.785	-3.47 score on a scale Standard Deviation 6.123	-2.05 score on a scale Standard Deviation 4.915
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 4 Change from Baseline	-0.90 score on a scale Standard Deviation 4.166	-3.32 score on a scale Standard Deviation 4.785	-3.74 score on a scale Standard Deviation 6.814	-3.80 score on a scale Standard Deviation 5.483
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 5 Change from Baseline	-0.90 score on a scale Standard Deviation 4.166	-3.32 score on a scale Standard Deviation 4.785	-3.74 score on a scale Standard Deviation 6.814	-5.85 score on a scale Standard Deviation 6.706
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 6 Change from Baseline	-2.30 score on a scale Standard Deviation 4.802	-4.16 score on a scale Standard Deviation 5.367	-5.37 score on a scale Standard Deviation 5.510	-6.05 score on a scale Standard Deviation 5.520
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 7 Change from Baseline	-3.90 score on a scale Standard Deviation 4.909	-4.84 score on a scale Standard Deviation 4.598	-5.32 score on a scale Standard Deviation 5.991	-7.10 score on a scale Standard Deviation 7.826
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 8 Change from Baseline	-5.25 score on a scale Standard Deviation 6.624	-4.47 score on a scale Standard Deviation 4.439	-6.21 score on a scale Standard Deviation 6.545	-7.60 score on a scale Standard Deviation 7.408
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 9 Change from Baseline	-7.00 score on a scale Standard Deviation 6.383	-3.79 score on a scale Standard Deviation 4.379	-5.79 score on a scale Standard Deviation 5.534	-9.10 score on a scale Standard Deviation 7.594
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 10 Change from Baseline	-5.90 score on a scale Standard Deviation 6.656	-5.16 score on a scale Standard Deviation 5.449	-8.26 score on a scale Standard Deviation 6.393	-8.35 score on a scale Standard Deviation 7.271
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 11 Change from Baseline	-6.65 score on a scale Standard Deviation 6.620	-5.47 score on a scale Standard Deviation 4.846	-6.37 score on a scale Standard Deviation 6.576	-9.00 score on a scale Standard Deviation 7.691
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity Visit 12 Change from Baseline	-5.55 score on a scale Standard Deviation 6.739	-5.79 score on a scale Standard Deviation 5.442	-5.42 score on a scale Standard Deviation 6.963	-8.50 score on a scale Standard Deviation 7.309

SECONDARY outcome

Timeframe: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment

The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the combined subscale, the scores range from 0-54, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.

Outcome measures

Outcome measures
Measure	Treatment 1 5/10mg TDD n=20 Participants SPN-810: capsule taken three times a day	Treatment 2 10/20mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 3 15/30mg TDD n=19 Participants SPN-810: capsule taken TID	Treatment 4 20/40mg TDD n=20 Participants SPN-810: capsule taken TID
SNAP-IV Subscales - ADHD Combined Visit 6 Change from Baseline	-3.45 score on a scale Standard Deviation 9.854	-8.37 score on a scale Standard Deviation 10.073	-12.53 score on a scale Standard Deviation 9.697	-11.65 score on a scale Standard Deviation 10.554
SNAP-IV Subscales - ADHD Combined Visit 7 Change from Baseline	-6.45 score on a scale Standard Deviation 9.361	-10.68 score on a scale Standard Deviation 8.838	-11.74 score on a scale Standard Deviation 11.293	-13.10 score on a scale Standard Deviation 15.082
SNAP-IV Subscales - ADHD Combined Visit 8 Change from Baseline	-9.20 score on a scale Standard Deviation 12.194	-10.16 score on a scale Standard Deviation 8.902	-13.26 score on a scale Standard Deviation 12.355	-14.25 score on a scale Standard Deviation 13.845
SNAP-IV Subscales - ADHD Combined Visit 9 Change from Baseline	-12.65 score on a scale Standard Deviation 12.006	-8.21 score on a scale Standard Deviation 8.203	-12.84 score on a scale Standard Deviation 10.678	-17.40 score on a scale Standard Deviation 14.702
SNAP-IV Subscales - ADHD Combined Visit 10 Change from Baseline	-11.05 score on a scale Standard Deviation 13.477	-10.58 score on a scale Standard Deviation 9.371	-17.16 score on a scale Standard Deviation 11.701	-15.90 score on a scale Standard Deviation 15.362
SNAP-IV Subscales - ADHD Combined Visit 11 Change from Baseline	-12.30 score on a scale Standard Deviation 13.111	-11.11 score on a scale Standard Deviation 8.730	-14.47 score on a scale Standard Deviation 12.294	-17.20 score on a scale Standard Deviation 14.877
SNAP-IV Subscales - ADHD Combined Visit 3 Change from Baseline	-2.45 score on a scale Standard Deviation 7.957	-7.11 score on a scale Standard Deviation 9.579	-7.32 score on a scale Standard Deviation 9.995	-3.40 score on a scale Standard Deviation 9.338
SNAP-IV Subscales - ADHD Combined Visit 12 Change from Baseline	-9.90 score on a scale Standard Deviation 12.251	-12.11 score on a scale Standard Deviation 9.944	-12.26 score on a scale Standard Deviation 12.596	-16.65 score on a scale Standard Deviation 14.203
SNAP-IV Subscales - ADHD Combined Baseline Score	37.80 score on a scale Standard Deviation 11.414	42.16 score on a scale Standard Deviation 7.537	39.11 score on a scale Standard Deviation 8.888	42.00 score on a scale Standard Deviation 8.240
SNAP-IV Subscales - ADHD Combined Visit 2 Change from Baseline	-2.45 score on a scale Standard Deviation 7.957	-3.21 score on a scale Standard Deviation 7.627	-3.26 score on a scale Standard Deviation 8.736	-0.95 score on a scale Standard Deviation 8.420
SNAP-IV Subscales - ADHD Combined Visit 4 Change from Baseline	-2.45 score on a scale Standard Deviation 7.957	-7.11 score on a scale Standard Deviation 9.579	-8.84 score on a scale Standard Deviation 11.758	-6.15 score on a scale Standard Deviation 10.569
SNAP-IV Subscales - ADHD Combined Visit 5 Change from Baseline	-2.45 score on a scale Standard Deviation 7.957	-7.11 score on a scale Standard Deviation 9.579	-8.84 score on a scale Standard Deviation 11.758	-11.15 score on a scale Standard Deviation 13.287

Adverse Events

Treatment 1 5/10mg TDD

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Treatment 2 10/20mg TDD

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Treatment 3 15/30mg TDD

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Treatment 4 20/40mg TDD

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment 1 5/10mg TDD n=20 participants at risk SPN-810: capsule taken three times a day	Treatment 2 10/20mg TDD n=19 participants at risk SPN-810: capsule taken TID	Treatment 3 15/30mg TDD n=19 participants at risk SPN-810: capsule taken TID	Treatment 4 20/40mg TDD n=20 participants at risk SPN-810: capsule taken TID
Psychiatric disorders Agitation	0.00% 0/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Number of events 1 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
Psychiatric disorders Abnormal behavior	0.00% 0/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.0% 1/20 • Number of events 1 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.

Other adverse events

Other adverse events
Measure	Treatment 1 5/10mg TDD n=20 participants at risk SPN-810: capsule taken three times a day	Treatment 2 10/20mg TDD n=19 participants at risk SPN-810: capsule taken TID	Treatment 3 15/30mg TDD n=19 participants at risk SPN-810: capsule taken TID	Treatment 4 20/40mg TDD n=20 participants at risk SPN-810: capsule taken TID
Nervous system disorders Somnolence	5.0% 1/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	26.3% 5/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	15.0% 3/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
Gastrointestinal disorders Abdominal pain upper	10.0% 2/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	21.1% 4/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.0% 2/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
General disorders Weight decreased	0.00% 0/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.5% 2/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	15.8% 3/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	15.0% 3/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
Reproductive system and breast disorders Upper Resipiratory Tract Infection	10.0% 2/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	15.8% 3/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.0% 1/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
Psychiatric disorders Insomnia	10.0% 2/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.5% 2/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.0% 2/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
General disorders Fatigue	10.0% 2/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	20.0% 4/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
General disorders Headache	5.0% 1/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	15.0% 3/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
Metabolism and nutrition disorders Decreased appetite	10.0% 2/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.5% 2/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
Nervous system disorders Akathisia	5.0% 1/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.5% 2/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.0% 1/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
Nervous system disorders Sedation	0.00% 0/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	20.0% 4/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	0.00% 0/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.0% 2/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
Infections and infestations Viral infection	0.00% 0/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.5% 2/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.5% 2/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
General disorders Pyrexia	0.00% 0/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.5% 2/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.3% 1/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.0% 1/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
General disorders Pain in extremity	5.0% 1/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	0.00% 0/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	10.5% 2/19 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.	5.0% 1/20 • Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.

Additional Information

Gianpiera Ceresoli-Borroni Director Clinical Research

Supernus Pharmaceuticals

Phone: 3018382521

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place