Trial Outcomes & Findings for Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD (NCT NCT03247556)

Last Updated: 2021-07-02

Results Overview

The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (\<0) represent a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

297 participants

Primary outcome timeframe

Baseline and Week 7 (End of Study)

Results posted on

2021-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Overall Study STARTED	97	100	99
Overall Study COMPLETED	85	88	81
Overall Study NOT COMPLETED	12	12	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Overall Study Adverse Event	1	4	5
Overall Study Lost to Follow-up	5	5	4
Overall Study Consent Withdrawn by Caregiver	4	1	5
Overall Study Assent/consent Withdrawn by Subject	0	2	2
Overall Study Protocol Violation	2	0	1
Overall Study Subject did not meet inclusion criteria	0	0	1

Baseline Characteristics

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=96 Participants Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=99 Participants 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=97 Participants 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo	Total n=292 Participants Total of all reporting groups
Age, Continuous	13.8 years STANDARD_DEVIATION 1.53 • n=5 Participants	14.0 years STANDARD_DEVIATION 1.74 • n=7 Participants	13.7 years STANDARD_DEVIATION 1.52 • n=5 Participants	13.8 years STANDARD_DEVIATION 1.60 • n=4 Participants
Age, Customized 12-14 years	63 Participants n=5 Participants	61 Participants n=7 Participants	72 Participants n=5 Participants	196 Participants n=4 Participants
Age, Customized 15-17 years	33 Participants n=5 Participants	38 Participants n=7 Participants	25 Participants n=5 Participants	96 Participants n=4 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	33 Participants n=7 Participants	26 Participants n=5 Participants	94 Participants n=4 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	66 Participants n=7 Participants	71 Participants n=5 Participants	198 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	34 Participants n=7 Participants	31 Participants n=5 Participants	97 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=5 Participants	65 Participants n=7 Participants	66 Participants n=5 Participants	194 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	33 Participants n=7 Participants	27 Participants n=5 Participants	85 Participants n=4 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	63 Participants n=7 Participants	66 Participants n=5 Participants	193 Participants n=4 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	96 participants n=5 Participants	99 participants n=7 Participants	97 participants n=5 Participants	292 participants n=4 Participants
ADHD-RS-5 Total Score	38.8 units on a scale STANDARD_DEVIATION 8.06 • n=5 Participants	41.2 units on a scale STANDARD_DEVIATION 7.80 • n=7 Participants	39.8 units on a scale STANDARD_DEVIATION 8.34 • n=5 Participants	39.9 units on a scale STANDARD_DEVIATION 8.10 • n=4 Participants
ADHD-RS-5 Inattention	22.4 units on a scale STANDARD_DEVIATION 3.59 • n=5 Participants	22.5 units on a scale STANDARD_DEVIATION 3.70 • n=7 Participants	22.3 units on a scale STANDARD_DEVIATION 3.82 • n=5 Participants	22.4 units on a scale STANDARD_DEVIATION 3.69 • n=4 Participants
ADHD-RS-5 Hyperactivity/Impulsivity	16.4 units on a scale STANDARD_DEVIATION 6.36 • n=5 Participants	18.7 units on a scale STANDARD_DEVIATION 5.59 • n=7 Participants	17.5 units on a scale STANDARD_DEVIATION 6.49 • n=5 Participants	17.6 units on a scale STANDARD_DEVIATION 6.21 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 7 (End of Study)

Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=99 Participants 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=97 Participants 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)	-13.2 units on a scale Standard Error 1.38	-18.3 units on a scale Standard Error 1.36	-16.7 units on a scale Standard Error 1.39

SECONDARY outcome

Timeframe: Week 7 (End of Study)

The first Key Secondary Endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 7 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = "very much improved" and 7 = "very much worse." Successful therapy is indicated by a lower overall score in subsequent testing.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=99 Participants 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=97 Participants 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale	2.9 units on a scale Standard Error 0.12	2.4 units on a scale Standard Error 0.12	2.6 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline and Week 7 (End of Study)

The second Key Secondary Endpoint was the change from baseline in the Conners 3rd Edition - Parent Short Form (C3PS) Composite T-score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS is completed by a child's parent/guardian and is comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rates his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true \[never, seldom\] and 3=very much true \[very often, very frequently\]) based on past month; the last 2 items are fill-in-the-blank. Raw scores are converted to T-scores. Lower change from baseline T-scores (\<0) represent a better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=99 Participants 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=97 Participants 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Effect of SPN-812 Assessed by Conners 3 - Parent Short Form (C3PS)	-5.6 T-score Standard Error 0.89	-7.5 T-score Standard Error 0.87	-6.9 T-score Standard Error 0.88

SECONDARY outcome

Timeframe: Baseline and Week 7 (End of Study)

The third Key Secondary Endpoint was the change from baseline in the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) Total Average score at Week 7 (End of Study). The WFIRS instrument evaluates ADHD-related functional impairment. The WFIRS-P is completed by the child's parent/guardian and is comprised of 50 items grouped into six domains: Family (10 items), School (10 items, includes learning \[4 items\] and behavior \[6 items\]), Life Skills (10 items), Child's Self-Concept (3 items), Social Activities (7 items), and Risky Activities (10 items). The parent/guardian rates each item on a 4-point Likert scale (0-3; where 0=never or not at all to 3= very often or very much) based on their child's behavior past month. A Total Average score was computed by calculating mean rating of all 50 items (ranging from 0 to 3, where a higher value represents more severe functional impairment). Lower change from baseline Total Average scores (\<0) represent a better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=99 Participants 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=97 Participants 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)	-0.23 units on a scale Standard Error 0.035	-0.32 units on a scale Standard Error 0.034	-0.23 units on a scale Standard Error 0.035

SECONDARY outcome

Timeframe: Week 7 (End of Study)

An additional secondary endpoint was the percentage of responders at Week 7 (End of Study). A responder was defined as a subject who had a 50% or greater reduction (improvement) in their change from baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). Values range from 0 to 100%. A higher percentage represents a greater number of responders.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=99 Participants 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=97 Participants 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)	32.9 percentage of subjects	48.2 percentage of subjects	46.0 percentage of subjects

SECONDARY outcome

Timeframe: Baseline and Week 7 (End of Study)

Another secondary endpoint was the change from baseline in the Stress Index for Parents of Adolescents (SIPA) Total score to Week 7 (End of Study). The SIPA is a 112-item screening/diagnostic instrument for parents of adolescents 11-19 years of age that identifies areas of stress in parent-adolescent interactions. Items 1-90 are rated on a 5-point Likert scale (where SD=Strongly Disagree, D=Disagree, NS=Not Sure, A=Agree, and SA=Strongly Agree) and yields a raw score for 3 Domains (Adolescent Domain, Parent Domain, and Adolescent-Parent Domain) that focus on a parent's perception of their child's personality and on the parent's characteristics and behaviors. The sum of the 3 Domain scores yields the Total (Parent Stress) score (range: 90-450; higher total scores indicate higher levels of stress). Lower change from baseline scores (\<0) represent a better outcome

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=99 Participants 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=97 Participants 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Effect of SPN-812 Assessed by Stress Index for Parents of Adolescents (SIPA)	-16.1 units on a scale Standard Error 3.40	-23.3 units on a scale Standard Error 3.33	-14.5 units on a scale Standard Error 3.38

SECONDARY outcome

Timeframe: Baseline and Week 7 (End of Study)

An additional secondary endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Hyperactivity/Impulsivity subscale score and Inattention subscale score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 DSM-5 symptoms of ADHD, including 9 items for the Hyperactivity/Impulsivity subscale and 9 items for the Inattention subscale. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). Each subscale score is calculated by adding the responses of all respective 9 items (range: 0-27; the higher the subscale score, the more severe the Hyperactivity/Impulsivity or Inattention symptoms). Lower change from baseline subscale scores (\<0) represent a better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=99 Participants 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=97 Participants 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Hyperactivity/impulsivity	-6.4 units on a scale Standard Error 0.69	-8.3 units on a scale Standard Error 0.68	-7.6 units on a scale Standard Error 0.71
Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Inattention	-7.1 units on a scale Standard Error 0.76	-10.1 units on a scale Standard Error 0.75	-8.7 units on a scale Standard Error 0.78

SECONDARY outcome

Timeframe: Baseline and Week 7 (End of Study)

An additional secondary endpoint was the change from baseline in the Conners 3rd Edition - Self Report Short Form (C3-SRS) Composite T score at Week 7 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3-SRS, which is only validated in children/adolescents 8-18 years of age, is comprised of 41 items with subsets of items related to five content scales: inattention, hyperactivity/impulsivity, learning problems, aggression and family relations. The subject rates himself/herself on the first 39 items of C3-SRS using a 4-point Likert scale (0-3; where 0=not at all true \[never, seldom\] and 3=very much true \[very often, very frequently\] based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (\<0) represent a better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=99 Participants 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=97 Participants 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Effect of SPN-812 Assessed by Conners 3 - Self Report Short Form	-4.4 T-score Standard Error 0.76	-5.4 T-score Standard Error 0.76	-6.6 T-score Standard Error 0.77

SECONDARY outcome

Timeframe: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7

An additional secondary endpoint was the percentage of subjects who were "improved" by visit; "improved" was defined as a subject who had a Clinical Global Impression - Improvement (CGI-I) score of 1 = "Very Much Improved" or 2 = "Much Improved". Values range from 0 to 100%. A higher percentage represents a greater number of subjects who were "improved".

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=99 Participants 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=97 Participants 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] Week 1	8.4 percentage of subjects	15.2 percentage of subjects	13.6 percentage of subjects
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] Week 2	17.1 percentage of subjects	33.1 percentage of subjects	25.4 percentage of subjects
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] Week 3	23.7 percentage of subjects	47.2 percentage of subjects	37.8 percentage of subjects
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] Week 4	29.5 percentage of subjects	46.1 percentage of subjects	39.1 percentage of subjects
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] Week 5	34.4 percentage of subjects	48.2 percentage of subjects	45.3 percentage of subjects
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] Week 6	37.5 percentage of subjects	56.5 percentage of subjects	46.6 percentage of subjects
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] Week 7	34.5 percentage of subjects	60.6 percentage of subjects	47.9 percentage of subjects

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

400mg SPN-812

Serious events: 2 serious events

Other events: 92 other events

Deaths: 0 deaths

600mg SPN-812

Serious events: 0 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=97 participants at risk Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=100 participants at risk 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=99 participants at risk 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Psychiatric disorders Suicide attempt	0.00% 0/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	1.0% 1/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	0.00% 0/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Nervous system disorders Syncope	0.00% 0/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	1.0% 1/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	0.00% 0/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)

Other adverse events

Other adverse events
Measure	Placebo n=97 participants at risk Placebo oral capsule Treatment A: Placebo was administered once daily	400mg SPN-812 n=100 participants at risk 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo	600mg SPN-812 n=99 participants at risk 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo
Nervous system disorders Somnolence	3.1% 3/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	14.0% 14/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	19.2% 19/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
General disorders Fatigue	4.1% 4/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	13.0% 13/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	10.1% 10/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Nervous system disorders Headache	10.3% 10/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	14.0% 14/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	9.1% 9/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Gastrointestinal disorders Nausea	4.1% 4/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	11.0% 11/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	9.1% 9/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Metabolism and nutrition disorders Decreased appetite	2.1% 2/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	6.0% 6/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	6.1% 6/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Psychiatric disorders Irritability	1.0% 1/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	6.0% 6/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	5.1% 5/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Gastrointestinal disorders Vomiting	2.1% 2/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	7.0% 7/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	4.0% 4/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Infections and infestations Nasopharyngitis	2.1% 2/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	6.0% 6/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	4.0% 4/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Gastrointestinal disorders Abdominal Pain Upper	4.1% 4/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	5.0% 5/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	4.0% 4/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Nervous system disorders Sedation	2.1% 2/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	5.0% 5/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	4.0% 4/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Gastrointestinal disorders Oropharyngeal pain	6.2% 6/97 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	5.0% 5/100 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)	0.00% 0/99 • 7 weeks Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)

Additional Information

Joseph Hull, PhD, Associate Director Clinical Research

Supernus

Phone: 240-403-5324

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER