Trial Outcomes & Findings for Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHD (NCT NCT03247530)

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 6 (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

477 participants

Primary outcome timeframe

Baseline and Week 6 (End of Study)

Results posted on

2021-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo oral capsule Treatment A: Placebo oral capsule was administered once daily	100mg SPN-812 SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 SPN-812 oral capsule Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
Overall Study STARTED	159	154	161
Overall Study COMPLETED	132	126	141
Overall Study NOT COMPLETED	27	28	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo oral capsule Treatment A: Placebo oral capsule was administered once daily	100mg SPN-812 SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 SPN-812 oral capsule Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
Overall Study Withdrawal by caregiver	19	8	10
Overall Study Lost to Follow-up	3	9	6
Overall Study Adverse Event	2	5	2
Overall Study Failure to follow procedure	1	1	1
Overall Study Withdrawal by Subject	1	1	0
Overall Study Study medication misuse	0	1	0
Overall Study Other, multiple categories	1	3	1

Baseline Characteristics

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=155 Participants Placebo oral capsule Treatment A: Placebo oral capsule was administered once daily	100mg SPN-812 n=147 Participants SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 n=158 Participants SPN-812 oral capsule Treatment C: 200mg SPN-812 was administered once daily and compared to placebo	Total n=460 Participants Total of all reporting groups
Age, Continuous	8.5 years STANDARD_DEVIATION 1.74 • n=5 Participants	8.5 years STANDARD_DEVIATION 1.70 • n=7 Participants	8.5 years STANDARD_DEVIATION 1.67 • n=5 Participants	8.5 years STANDARD_DEVIATION 1.70 • n=4 Participants
Age, Customized 6 to 9 years	103 Participants n=5 Participants	103 Participants n=7 Participants	107 Participants n=5 Participants	313 Participants n=4 Participants
Age, Customized 10 to 11 years	52 Participants n=5 Participants	44 Participants n=7 Participants	51 Participants n=5 Participants	147 Participants n=4 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	53 Participants n=7 Participants	59 Participants n=5 Participants	170 Participants n=4 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	94 Participants n=7 Participants	99 Participants n=5 Participants	290 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	38 Participants n=7 Participants	51 Participants n=5 Participants	121 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants n=5 Participants	108 Participants n=7 Participants	107 Participants n=5 Participants	338 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 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	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	69 Participants n=5 Participants	63 Participants n=7 Participants	69 Participants n=5 Participants	201 Participants n=4 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants	76 Participants n=7 Participants	83 Participants n=5 Participants	236 Participants n=4 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	20 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	155 participants n=5 Participants	147 participants n=7 Participants	158 participants n=5 Participants	460 participants n=4 Participants
ADHD-RS-5 Total Score	43.6 units on a scale STANDARD_DEVIATION 7.05 • n=5 Participants	45.0 units on a scale STANDARD_DEVIATION 6.53 • n=7 Participants	44.0 units on a scale STANDARD_DEVIATION 6.80 • n=5 Participants	44.2 units on a scale STANDARD_DEVIATION 6.81 • n=4 Participants
ADHD-RS-5 Inattention Subscale Score	22.5 units on a scale STANDARD_DEVIATION 3.79 • n=5 Participants	22.8 units on a scale STANDARD_DEVIATION 3.24 • n=7 Participants	22.9 units on a scale STANDARD_DEVIATION 3.53 • n=5 Participants	22.7 units on a scale STANDARD_DEVIATION 3.53 • n=4 Participants
ADHD-RS-5 Hyperactivity/Impulsivity Subscale Score	21.1 units on a scale STANDARD_DEVIATION 4.90 • n=5 Participants	22.2 units on a scale STANDARD_DEVIATION 4.65 • n=7 Participants	21.1 units on a scale STANDARD_DEVIATION 5.15 • n=5 Participants	21.5 units on a scale STANDARD_DEVIATION 4.92 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6 (End of Study)

Outcome measures

Outcome measures
Measure	Placebo n=155 Participants Placebo, oral capsule Treatment A: Placebo was administered once daily	100mg SPN-812 n=147 Participants SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 n=158 Participants SPN-812 oral capsule Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale, 5th Edition (ADHD-RS-5)	-10.9 score on a scale Standard Error 1.14	-16.6 score on a scale Standard Error 1.16	-17.7 score on a scale Standard Error 1.12

SECONDARY outcome

Timeframe: Week 6 (End of Study)

The first Key Secondary Endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 6 (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=155 Participants Placebo, oral capsule Treatment A: Placebo was administered once daily	100mg SPN-812 n=147 Participants SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 n=158 Participants SPN-812 oral capsule Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale	3.1 score on a scale Standard Error 0.10	2.7 score on a scale Standard Error 0.10	2.6 score on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline and Week 6 (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 6 (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 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=155 Participants Placebo, oral capsule Treatment A: Placebo was administered once daily	100mg SPN-812 n=147 Participants SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 n=158 Participants SPN-812 oral capsule Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
Effect of SPN-812 Assessed by Conners 3 - Parent Short Form (C3PS)	-4.8 T-score Standard Error 0.81	-9.1 T-score Standard Error 0.83	-9.2 T-score Standard Error 0.82

SECONDARY outcome

Timeframe: Baseline and Week 6 (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 6 (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=155 Participants Placebo, oral capsule Treatment A: Placebo was administered once daily	100mg SPN-812 n=147 Participants SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 n=158 Participants SPN-812 oral capsule Treatment C: 200mg 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)	-0.22 score on a scale Standard Error 0.033	-0.36 score on a scale Standard Error 0.033	-0.39 score on a scale Standard Error 0.032

SECONDARY outcome

Timeframe: Week 6 (End of Study)

An additional secondary endpoint was the percentage of responders at Week 6 (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 6 (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=155 Participants Placebo, oral capsule Treatment A: Placebo was administered once daily	100mg SPN-812 n=147 Participants SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 n=158 Participants SPN-812 oral capsule Treatment C: 200mg 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)	19.8 percentage of subjects	34.2 percentage of subjects	41.2 percentage of subjects

SECONDARY outcome

Timeframe: Baseline and Week 6 (End of Study)

An additional secondary endpoint was the change from baseline in Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF) Total score at Week 6 (End of Study). The PSI-4 questionnaire evaluates the magnitude of stress in the parent-child relationship based on the parent's perception of the child's characteristics, the personal characteristics of the parent, and the interaction between the parent and the child. The PSI-4-SF was developed for parents of children ages 1 month to 12 years. The PSI-4-SF consists of 36 items divided into three domains: parental distress, parent-child dysfunctional interaction, and difficult child. Each item is rated on a 5-point Likert scale, where SD=Strongly Disagree, D=Disagree, NS=Not Sure, A=Agree, and SA=Strongly Agree. The total score ranges between 90 and 450; higher total scores indicate higher levels of stress. Lower change from baseline total scores (\<0) represent better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=155 Participants Placebo, oral capsule Treatment A: Placebo was administered once daily	100mg SPN-812 n=147 Participants SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 n=158 Participants SPN-812 oral capsule Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
Effect of SPN-812 Assessed by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF)	-8.5 score on a scale Standard Error 1.61	-8.5 score on a scale Standard Error 1.63	-10.1 score on a scale Standard Error 1.58

SECONDARY outcome

Timeframe: Baseline and Week 6 (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 6 (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=155 Participants Placebo, oral capsule Treatment A: Placebo was administered once daily	100mg SPN-812 n=147 Participants SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 n=158 Participants SPN-812 oral capsule Treatment C: 200mg 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) Inattention subscale	-5.7 score on a scale Standard Error 0.60	-8.6 score on a scale Standard Error 0.62	-9.2 score on a scale Standard Error 0.60
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 Subscale	-5.5 score on a scale Standard Error 0.59	-8.0 score on a scale Standard Error 0.60	-8.7 score on a scale Standard Error 0.58

SECONDARY outcome

Timeframe: Baseline and Week 6 (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. There is a lower 'N' for this scale because the scale was only completed by subjects 8 to 11 years of age, since this specific scale is only validated in children 8-18 years of age.

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 6 (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=100 Participants Placebo, oral capsule Treatment A: Placebo was administered once daily	100mg SPN-812 n=102 Participants SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 n=107 Participants SPN-812 oral capsule Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
Effect of SPN-812 Assessed by Conners 3 - Self Report Short Form (C3-SRS)	-3.5 T-score Standard Error 0.85	-5.3 T-score Standard Error 0.84	-4.6 T-score Standard Error 0.83

SECONDARY outcome

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

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=155 Participants Placebo, oral capsule Treatment A: Placebo was administered once daily	100mg SPN-812 n=147 Participants SPN-812 oral capsule Treatment B: 100mg SPN-812 was administered once daily and compared to placebo	200mg SPN-812 n=158 Participants SPN-812 oral capsule Treatment C: 200mg 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	9.1 percentage of subjects	23.9 percentage of subjects	10.9 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	18.9 percentage of subjects	30.5 percentage of subjects	31.8 percentage of subjects
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] Week 3	26.7 percentage of subjects	40.7 percentage of subjects	38.9 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	29.3 percentage of subjects	46.5 percentage of subjects	48.2 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	30.7 percentage of subjects	46.3 percentage of subjects	48.1 percentage of subjects
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] Week 6	29.5 percentage of subjects	45.0 percentage of subjects	50.7 percentage of subjects

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

100mg SPN-812

Serious events: 2 serious events

Other events: 54 other events

Deaths: 0 deaths

200mg SPN-812

Serious events: 1 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=159 participants at risk Placebo oral capsule Treatment A: Placebo administered once daily	100mg SPN-812 n=154 participants at risk SPN-812 oral capsule Treatment B: 100mg SPN-812 administered once daily and compared to placebo	200mg SPN-812 n=161 participants at risk SPN-812 oral capsule Treatment C: 200mg SPN-812 administered once daily and compared to placebo
Psychiatric disorders Pyromania	0.00% 0/159 • 6 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)	0.65% 1/154 • 6 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% 0/161 • 6 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 Conduct disorder	0.00% 0/159 • 6 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)	0.65% 1/154 • 6 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% 0/161 • 6 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 Appendicitis	0.00% 0/159 • 6 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% 0/154 • 6 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)	0.62% 1/161 • 6 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=159 participants at risk Placebo oral capsule Treatment A: Placebo administered once daily	100mg SPN-812 n=154 participants at risk SPN-812 oral capsule Treatment B: 100mg SPN-812 administered once daily and compared to placebo	200mg SPN-812 n=161 participants at risk SPN-812 oral capsule Treatment C: 200mg SPN-812 administered once daily and compared to placebo
Nervous system disorders Headache	3.8% 6/159 • 6 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)	9.7% 15/154 • 6 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)	9.9% 16/161 • 6 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 Somnolence	1.9% 3/159 • 6 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)	10.4% 16/154 • 6 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)	9.3% 15/161 • 6 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	0.00% 0/159 • 6 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)	5.2% 8/154 • 6 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)	8.7% 14/161 • 6 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	1.9% 3/159 • 6 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)	4.5% 7/154 • 6 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% 8/161 • 6 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	1.9% 3/159 • 6 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)	3.2% 5/154 • 6 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% 8/161 • 6 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	0.00% 0/159 • 6 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)	1.9% 3/154 • 6 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)	5.6% 9/161 • 6 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