Trial Outcomes & Findings for Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD (NCT NCT04786990)
NCT ID: NCT04786990
Last Updated: 2024-05-01
Results Overview
The percent of subjects who took at least one dose of SPN-812 and reported at least one adverse event during 8 weeks of adjunct SPN-812 Treatment. The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and then multiplying the product by 100. The higher the percent, the higher the incidence.
COMPLETED
PHASE4
96 participants
Weeks 1-8
2024-05-01
Participant Flow
Participant milestones
| Measure |
Open-Label Treatment
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Open-Label Treatment
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Noncompliance
|
1
|
|
Overall Study
Unable to complete site visits
|
1
|
|
Overall Study
Withdrawal by Parent/Guardian
|
3
|
Baseline Characteristics
Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD
Baseline characteristics by cohort
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Age, Categorical
<=18 years
|
56 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
11.8 years
STANDARD_DEVIATION 2.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
|
Investigator-rated Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (IR-ADHD-RS-5)
|
37.2 units on a scale
STANDARD_DEVIATION 8.35 • n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1-8Population: Safety Population, defined as subjects who signed Informed Consent and took at least one dose of SPN-812.
The percent of subjects who took at least one dose of SPN-812 and reported at least one adverse event during 8 weeks of adjunct SPN-812 Treatment. The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and then multiplying the product by 100. The higher the percent, the higher the incidence.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Incidence of Adverse Events During 8 Weeks of Adjunct SPN-812 Treatment
|
55.4 percent of subjects
|
SECONDARY outcome
Timeframe: Weeks 1-4 and Weeks 5-8Population: Safety Population, defined as subjects who signed Informed Consent and took at least one dose of SPN-812. The data (percent of subjects who reported at least one adverse event for Weeks 1-4 or Weeks 5-8) is summarized by the number of subjects analyzed (subjects who took at least one dose of SPN-812 during Weeks 1-4 or Weeks 5-8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The percent of subjects who reported at least one adverse event during adjunctive SPN-812 Treatment during Weeks 1-4 (SPN-812 dosed in morning hours \[AM Dosing\]) and during Weeks 5-8 (SPN-812 dosed in evening hours \[PM Dosing\]). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n) during Weeks 1-4 or Weeks 5-8" by "the number of subjects analyzed during Weeks 1-4 or Weeks 5-8" (subjects who took at least once dose of SPN-812 during Weeks 1-4 or Weeks 5-8), respectively and then multiplying the product of each by 100. The higher the percent, the higher the incidence.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Incidence of Adverse Events During Adjunctive SPN-812 Treatment During Weeks 1-4 (SPN-812 Dosed in Morning Hours [AM Dosing]) and During Weeks 5-8 (SPN-812 Dosed in Evening Hours [PM Dosing])
Percent of subjects; Weeks 1-4
|
50.0 Percent of subjects
|
|
Incidence of Adverse Events During Adjunctive SPN-812 Treatment During Weeks 1-4 (SPN-812 Dosed in Morning Hours [AM Dosing]) and During Weeks 5-8 (SPN-812 Dosed in Evening Hours [PM Dosing])
Percent of subjects; Weeks 5-8
|
36.0 Percent of subjects
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Investigator-rated ADHD Rating Scale, 5th Edition \[IR-ADHD-RS-5\] assessment at baseline \[pre-dosing\] and at Week 4 or Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (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 was rated by a trained investigator on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). The sum of all 18 items yields the raw Total score (range: 0-54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Investigator-rated Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (IR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-13.5 score on a scale
Standard Deviation 9.70
|
|
Change From Baseline in the Investigator-rated Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (IR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
37.2 score on a scale
Standard Deviation 8.35
|
|
Change From Baseline in the Investigator-rated Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (IR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-18.2 score on a scale
Standard Deviation 9.99
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Clinical Global Impression-Severity of Illness Scale \[CGI-S\] assessment at baseline \[pre-dosing\] and at Week 4 or Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Clinical Global Impression-Severity of Illness (CGI-S) scale is a single item clinician-rated assessment of the severity of the ADHD symptoms in relation to the clinician's total experience with patients with ADHD. The CGI-S is evaluated by the investigator on a 7-point scale, where 1 = Normal, not at all ill; 2 = Borderline mentally Ill; 3 = Mildly Ill; 4 = Moderately Ill; 5 = Markedly Ill; 6 = Severely Ill; and 7 = Among the most extremely ill patients; the higher the score, the more severe the ADHD symptoms. Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
4.4 score on a scale
Standard Deviation 0.56
|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-0.9 score on a scale
Standard Deviation 0.92
|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-1.4 score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Clinical Global Impression-Improvement \[CGI-I\] assessment at Week 4 or Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Clinical Global Impression-Improvement (CGI-I) is a single item, clinician-rated assessment of how much the clinician believes the subject's overall symptoms have changed (improved, worsened or no change) relative to subject's baseline state prior to the beginning of treatment. The CGI-I is evaluated by the investigator on a 7-point scale, where 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 CGI-I score \<4 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Clinical Global Impression-Improvement (CGI-I) Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Week 4
|
2.8 score on a scale
Standard Deviation 0.95
|
|
Clinical Global Impression-Improvement (CGI-I) Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Week 8
|
2.3 score on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\] and at Week 4 or at Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six Subscale scores are generated: (1) disorders of initiating and maintaining sleep (7 items), (2) sleep breathing disorders (3 items), (3) disorders of arousal (3 items), (4) sleep-wake transition disorders (6 items), (5) disorders of excessive somnolence (5 items), and (6) sleep hyperhidrosis (2 items). The sum of all Subscale scores yields the raw Total score (range: 26 to 130; the higher the score, the more severe sleep disturbance). Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
54.4 score on a scale
Standard Deviation 17.75
|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-8.8 score on a scale
Standard Deviation 14.03
|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-10.3 score on a scale
Standard Deviation 17.39
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\] and at Week 4 or at Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Disorders of Initiating and Maintaining Sleep (DIMS) Subscale (items 1,2,3,4,5,10, and 11). The sum of the 7 items yields the raw Subscale score (range: 7 to 35; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) "Disorders of Initiating and Maintaining Sleep (DIMS)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
19.9 score on a scale
Standard Deviation 6.38
|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) "Disorders of Initiating and Maintaining Sleep (DIMS)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-3.2 score on a scale
Standard Deviation 4.84
|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) "Disorders of Initiating and Maintaining Sleep (DIMS)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-4.2 score on a scale
Standard Deviation 6.08
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\] and at Week 4 or at Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Sleep Breathing Disorder (SBD) Subscale (items 13, 14, and 15). The sum of the 3 items yields the raw Subscale score (range: 5 to 15; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Sleep Disorders Scale for Children (SDSC) "Sleep Breathing Disorder (SBD)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
4.2 score on a scale
Standard Deviation 2.07
|
|
Change From Baseline in the Sleep Disorders Scale for Children (SDSC) "Sleep Breathing Disorder (SBD)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-0.5 score on a scale
Standard Deviation 1.85
|
|
Change From Baseline in the Sleep Disorders Scale for Children (SDSC) "Sleep Breathing Disorder (SBD)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-0.3 score on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\] and at Week 4 or at Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Disorders of Arousal (DA) Subscale (items 17, 20, and 21). The sum of the 3 items yields the raw Subscale score (range: 5 to 15; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) "Disorders of Arousal (DA)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
3.9 score on a scale
Standard Deviation 1.50
|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) "Disorders of Arousal (DA)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-0.3 score on a scale
Standard Deviation 1.17
|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) "Disorders of Arousal (DA)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-0.2 score on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\] and at Week 4 or at Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Sleep-Wake Transition Disorders (STD) Subscale (items 6, 7, 8, 12, 18, and 19). The sum of the 6 items yields the raw Subscale score (range: 6 to 30; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) "Sleep-Wake Transition Disorders (STD)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
11.8 score on a scale
Standard Deviation 5.13
|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) "Sleep-Wake Transition Disorders (STD)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-1.8 score on a scale
Standard Deviation 4.49
|
|
Change From Baseline in the Sleep Disturbance Scale for Children (SDSC) "Sleep-Wake Transition Disorders (STD)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-2.5 score on a scale
Standard Deviation 5.04
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\] and at Week 4 or at Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Disorders of Excessive Somnolence (DES) Subscale (items 22, 23, 24, 25, and 26). The sum of the 5 items yields the raw Subscale score (range: 5 to 25; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Sleep Disorders Scale for Children (SDSC) "Disorders of Excessive Somnolence (DES)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
11.0 score on a scale
Standard Deviation 4.66
|
|
Change From Baseline in the Sleep Disorders Scale for Children (SDSC) "Disorders of Excessive Somnolence (DES)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-2.3 score on a scale
Standard Deviation 3.87
|
|
Change From Baseline in the Sleep Disorders Scale for Children (SDSC) "Disorders of Excessive Somnolence (DES)" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-2.3 score on a scale
Standard Deviation 4.87
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\] and at Week 4 or at Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Sleep Hyperhidrosis (SH) Subscale (items 9 and 16). The sum of the 2 items yields the raw Subscale score (range: 2 to 10; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Sleep Disorders Scale for Children (SDSC) "Sleep Hyperhidrosis (SH)" Subscale Scores at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
3.7 score on a scale
Standard Deviation 2.61
|
|
Change From Baseline in the Sleep Disorders Scale for Children (SDSC) "Sleep Hyperhidrosis (SH)" Subscale Scores at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-0.7 score on a scale
Standard Deviation 1.99
|
|
Change From Baseline in the Sleep Disorders Scale for Children (SDSC) "Sleep Hyperhidrosis (SH)" Subscale Scores at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-0.8 score on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Weekly Parent Rating of Evening and Morning Behavior-Revised \[WPREMB-R\] assessment at baseline \[pre-dosing\] and at Week 4 or at Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) is a validated, 11-item scale for the assessment of ADHD-related morning and evening behaviors impacting at-home functioning in children with ADHD. There are 3 items related to morning behaviors and 8 items related to evening behaviors. The parent/guardian rates each item on a 4-point scale based on their child's behavior during the past week, where 0 = "no difficulty" to 3 = "a lot of difficulty". The sum of all 11 items yields a Total score (range: 0-33); the higher the score, the more severe the impairment/difficulty. Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
19.6 score on a scale
Standard Deviation 6.39
|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-5.2 score on a scale
Standard Deviation 6.03
|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-7.7 score on a scale
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Weekly Parent Rating of Evening and Morning Behavior-Revised \[WPREMB-R\] assessment at baseline \[pre-dosing\] and at Week 4 or at Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) is a validated, 11-item scale for the assessment of ADHD-related morning and evening behaviors impacting at-home functioning in children with ADHD. There are 3 items related to morning behaviors and 8 items related to evening behaviors. The parent/guardian rates each item on a 4-point scale based on their child's behavior during the past week, where 0 = "no difficulty" to 3 = "a lot of difficulty". The sum of all 3 items related to morning behaviors yields a WPREMB-R Morning Behaviors Subscale score (range: 0-9); the higher the score, the more severe the impairment/difficulty. Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) "Morning Behaviors" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
5.4 score on a scale
Standard Deviation 2.32
|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) "Morning Behaviors" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-1.2 score on a scale
Standard Deviation 2.18
|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) "Morning Behaviors" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-1.6 score on a scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Weekly Parent Rating of Evening and Morning Behavior-Revised \[WPREMB-R\] assessment at baseline \[pre-dosing\] and at Week 4 or at Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) is a validated, 11-item scale for the assessment of ADHD-related morning and evening behaviors impacting at-home functioning in children with ADHD. There are 3 items related to morning behaviors and 8 items related to evening behaviors. The parent/guardian rates each item on a 4-point scale based on their child's behavior during the past week, where 0 = "no difficulty" to 3 = "a lot of difficulty". The sum of all 8 items related to evening behaviors yields a WPREMB-R Evening Behaviors Subscale score (range: 0-24); the higher the score, the more severe the impairment/difficulty. Raw score is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) "Evening Behaviors" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
14.2 score on a scale
Standard Deviation 5.00
|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) "Evening Behaviors" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-4.1 score on a scale
Standard Deviation 4.44
|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) "Evening Behaviors" Subscale Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-6.1 score on a scale
Standard Deviation 5.27
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Investigator-rated ADHD Rating Scale, 5th Edition \[IR-ADHD-RS-5\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (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 was rated by a trained investigator on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). The sum of all 18 items yields the raw Total score (range: 0-54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=48 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Investigator-rated Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (IR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) Versus Week 8 (PM Dosing)
|
-4.8 score on a scale
Standard Deviation 8.90
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Clinical Global Impression-Severity of Illness Scale \[CGI-S\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Clinical Global Impression-Severity of Illness (CGI-S) scale is a single item clinician-rated assessment of the severity of the ADHD symptoms in relation to the clinician's total experience with patients with ADHD. The CGI-S is evaluated by the investigator on a 7-point scale, where 1 = Normal, not at all ill; 2 = Borderline mentally Ill; 3 = Mildly Ill; 4 = Moderately Ill; 5 = Markedly Ill; 6 = Severely Ill; and 7 = Among the most extremely ill patients; the higher the score, the more severe the ADHD symptoms. Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=48 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
-0.5 score on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid Clinical Global Impression-Improvement \[CGI-I\] assessment at Week 4 and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Clinical Global Impression-Improvement (CGI-I) is a single item, clinician-rated assessment of how much the clinician believes the subject's overall symptoms have changed (improved, worsened or no change) relative to subject's baseline state prior to the beginning of treatment. The CGI-I is evaluated by the investigator on a 7-point scale, where 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 mean difference (the Week 8 minus the Week 4 CGI-I score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=48 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Clinical Global Impression-Improvement (CGI-I) Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
-0.5 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". 6 Subscale scores are generated: 1) disorders of initiating and maintaining sleep, 7 items; 2) sleep breathing disorders, 3 items; 3) disorders of arousal, 3 items; 4) sleep-wake transition disorders, 6 items; 5) disorders of excessive somnolence, 5 items; and 6) sleep hyperhidrosis, 2 items. Sum of all Subscale scores yields a raw Total score (range: 26 to 130; higher score indicates more severe sleep disturbance). Raw score is converted to a change from baseline (CFB) score. A mean difference (Week 8 minus Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=46 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Sleep Disturbance Scale for Children (SDSC) Total Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
-0.2 score on a scale
Standard Deviation 9.54
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Disorders of Initiating and Maintaining Sleep (DIMS) Subscale (items 1, 2, 3, 4, 5, 10, and 11). The sum of the 7 items yields the raw Subscale score (range: 7 to 35; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=46 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Sleep Disorders Scale for Children (SDSC) "Disorders of Initiating and Maintaining Sleep (DIMS)" Subscale Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
-0.5 score on a scale
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Sleep Breathing Disorder (SBD) Subscale (items 13, 14, and 15). The sum of the 3 items yields the raw Subscale score (range: 5 to 15; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=46 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Sleep Disorders Scale for Children (SDSC) "Sleep Breathing Disorder (SBD)" Subscale Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
0.2 score on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disorders Scale for Children (SDSC) is a 26-item, parent-reported measure used to screen for sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Disorders of Arousal (DA) Subscale (items 17, 20, and 21). The sum of the 3 items yields the raw Subscale score (range: 5 to 15; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=46 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Sleep Disturbance Scale in Children (SDSC) "Disorders of Arousal (DA)" Subscale Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
0.1 score on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disorders Scale for Children (SDSC) is a 26-item, parent-reported measure used to screen for sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Sleep-Wake Transition Disorders (STD) Subscale (items 6, 7, 8, 12, 18, and 19). The sum of the 6 items yields the raw Subscale score (range: 6 to 30; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=46 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Sleep Disorders Scale for Children (SDSC) "Sleep-Wake Transition Disorders (STD)" Subscale Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
-0.3 score on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency: 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Disorders of Excessive Somnolence (DES) Subscale (items 22, 23, 24, 25, and 26). The sum of the 5 items yields the raw Subscale score (range: 5 to 25; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=46 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Sleep Disorders Scale for Children (SDSC) "Disorders of Excessive Somnolence" (DES) Subscale Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
0.4 score on a scale
Standard Deviation 3.75
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Sleep Disturbance Scale for Children \[SDSC\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Sleep Disturbance Scale for Children (SDSC) is a 26-item, parent-rated scale that assesses the presence of sleep disturbances in children/adolescents. All items are rated on a 5-point scale based on past week; Item 1, average sleep duration: 1 = "9-11 h" to 5 = "less than 5 h"; Item 2, average sleep latency, 1 = "less than 15 min" to 5 = "more than 60 min"); Items 3-26, sleep disturbances: 1 = "Never" to 5 = "Always". Six subscale scores are generated, including the Sleep Hyperhidrosis (SH) Subscale (items 9 and 16). The sum of the 2 items yields the raw Subscale score (range: 2 to 10; the higher the score, the more severe the disturbance). Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=46 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the Sleep Disorders Scale for Children (SDSC) "Sleep Hyperhidrosis (SH)" Subscale Scores at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
0.0 score on a scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Weekly Parent Rating of Evening and Morning Behavior-Revised \[WPREMB-R\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) is a validated, 11-item scale for the assessment of ADHD-related morning and evening behaviors impacting at-home functioning in children with ADHD. There are 3 items related to morning behaviors and 8 items related to evening behaviors. The parent/guardian rates each item on a 4-point scale based on their child's behavior during the past week, where 0 = "no difficulty" to 3 = "a lot of difficulty". The sum of all 11 items yields a Total score (range: 0-33); the higher the score, the more severe the impairment/difficulty. Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=47 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
-2.4 score on a scale
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Weekly Parent Rating of Evening and Morning Behavior-Revised \[WPREMB-R\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) is a validated, 11-item scale for the assessment of ADHD-related morning and evening behaviors impacting at-home functioning in children with ADHD. There are 3 items related to morning behaviors and 8 items related to evening behaviors. The parent/guardian rates each item on a 4-point scale based on their child's behavior during the past week, where 0 = "no difficulty" to 3 = "a lot of difficulty". The sum of all 3 items related to morning behaviors yields a WPREMB-R Morning Behaviors Subscale score (range: 0-9); the higher the score, the more severe the impairment/difficulty. Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=47 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) "Morning Behaviors" Subscale Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
-0.5 score on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid Weekly Parent Rating of Evening and Morning Behavior-Revised \[WPREMB-R\] assessment at baseline \[pre-dosing\], Week 4, and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) is a validated, 11-item scale for the assessment of ADHD-related morning and evening behaviors impacting at-home functioning in children with ADHD. There are 3 items related to morning behaviors and 8 items related to evening behaviors. The parent/guardian rates each item on a 4-point scale based on their child's behavior during the past week, where 0 = "no difficulty" to 3 = "a lot of difficulty". The sum of all 8 items related to evening behaviors yields a WPREMB-R Evening Behaviors Subscale score (range: 0-24); the higher the score, the more severe the impairment/difficulty. Raw score is converted to a change from baseline (CFB) score. A mean difference (the Week 8 minus the Week 4 CFB score) \<0 represents a better outcome at Week 8.
Outcome measures
| Measure |
Open-Label Treatment
n=47 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) "Evening Behaviors" Subscale Score at Week 4 (AM Dosing) Versus at Week 8 (PM Dosing)
|
-1.9 score on a scale
Standard Deviation 4.78
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid "Morning" Parent-rated ADHD Rating Scale, 5th Edition \[PR-ADHD-RS-5\] assessment at baseline \[pre-dosing\] and at Week 4 or Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (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. Parent/guardian rates each item on a 4-point scale from 0 (never or rarely) to 3 (very often) based on observations of their child's behavior during the morning hours in the past week. The raw Total score (sum of 18 items range: 0-54; the higher the score, the more severe the ADHD symptoms in morning hours), is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in the "Morning" Parent-rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
32.6 score on a scale
Standard Deviation 12.10
|
|
Change From Baseline in the "Morning" Parent-rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-10.2 score on a scale
Standard Deviation 11.90
|
|
Change From Baseline in the "Morning" Parent-rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-12.0 score on a scale
Standard Deviation 14.28
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data at each Week/Visit is summarized with descriptive statistics for the number of subjects analyzed (n; subjects with a valid "Evening" Parent-rated ADHD Rating Scale, 5th Edition \[PR-ADHD-RS-5\] assessment at baseline \[pre-dosing\] and at Week 4 or Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (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. Parent/guardian rates each item on a 4-point scale from 0 (never or rarely) to 3 (very often) based on observations of their child's behavior during the evening hours in the past week. The raw Total score (sum of 18 items range: 0-54; the higher the score, the more severe the ADHD symptoms in morning hours), is converted to a change from baseline (CFB) score. A CFB score \<0 represents a better outcome.
Outcome measures
| Measure |
Open-Label Treatment
n=56 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change From Baseline in "Evening" Parent-rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Raw score; Baseline
|
33.6 score on a scale
Standard Deviation 10.50
|
|
Change From Baseline in "Evening" Parent-rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 4
|
-9.6 score on a scale
Standard Deviation 11.24
|
|
Change From Baseline in "Evening" Parent-rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total Score at Week 4 (AM Dosing) and at Week 8 (PM Dosing)
Change from Baseline score; Week 8
|
-14.3 score on a scale
Standard Deviation 11.62
|
SECONDARY outcome
Timeframe: Week 4Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized with by number of subjects analyzed (n; subjects with a valid "Morning" and "Evening" Parent-rated ADHD Rating Scale, 5th Edition \[PR-ADHD-RS-5\] assessment at baseline \[pre-dosing\] and Week 4). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (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. Parent/guardian rates each of 18 items on the "Morning" PR-ADHD-RS-5 and each of 18 items on the "Evening" PR-ADHD-RS-5 on a 4-point scale from 0 (never or rarely) to 3 (very often) based on observations of their child's behavior during the morning hours in past week and evening hours in the past week, respectively. For each assessment, the raw Total score (sum of 18 items; range: 0-54; the higher the score, the more severe the morning or evening ADHD symptoms) is converted to a change from baseline (CFB) score. A mean difference (the Evening minus the Morning CFB score) \<0 represents a better outcome in the Evening.
Outcome measures
| Measure |
Open-Label Treatment
n=33 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change in Baseline in the "Morning" Versus "Evening" Parent-rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total Score at Week 4 (AM Dosing)
|
1.1 score on a scale
Standard Deviation 10.59
|
SECONDARY outcome
Timeframe: Week 8Population: Safety Population (N), defined as subjects who signed Informed Consent and took at least one dose of SPN-812. Data is summarized by number of subjects analyzed (n; subjects with a valid "Morning" and "Evening" Parent-rated ADHD Rating Scale, 5th Edition \[PR-ADHD-RS-5\] assessment at baseline \[pre-dosing\] and Week 8). Due to attrition and/or missing data, the number of subjects analyzed may be less than and unequal to the Safety Population.
The Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (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. Parent/guardian rates each of 18 items on the "Morning" PR-ADHD-RS-5 and each of 18 items on the "Evening" PR-ADHD-RS-5 on a 4-point scale from 0 (never or rarely) to 3 (very often) based on observations of their child's behavior during the morning hours in past week and evening hours in the past week, respectively. For each assessment, the raw Total score (sum of 18 items range: 0-54; the higher the score, the more severe the morning or evening ADHD symptoms) is converted to a change from baseline (CFB) score. A mean difference (the Evening minus the Morning CFB score) \<0 represents a better outcome in the Evening.
Outcome measures
| Measure |
Open-Label Treatment
n=23 Participants
SPN-812 (viloxazine extended-release capsules)
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
|
|---|---|
|
Change in Baseline in the "Morning" Versus "Evening" Parent-rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total Score at Week 8 (PM Dosing)
|
-1.6 score on a scale
Standard Deviation 11.41
|
Adverse Events
Open-Label Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-Label Treatment
n=56 participants at risk
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule)
Subjects 12-17 years of age: 100 to 600mg SPN-812 (100 mg, 200 mg oral capsule)
SPN-812: Viloxazine extended-release capsule
|
|---|---|
|
Nervous system disorders
Headache
|
17.9%
10/56 • Number of events 10 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose administration at Baseline visit up to nine weeks (i.e., safety follow up phone call 1 week after end of study visit).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication. Since the same subjects progress through Weeks 1 - 8, the same subject may be counted in Week 1 - 4, Week 5 - 8, Overall Duration, and Post treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
12.5%
7/56 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose administration at Baseline visit up to nine weeks (i.e., safety follow up phone call 1 week after end of study visit).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication. Since the same subjects progress through Weeks 1 - 8, the same subject may be counted in Week 1 - 4, Week 5 - 8, Overall Duration, and Post treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.7%
6/56 • Number of events 6 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose administration at Baseline visit up to nine weeks (i.e., safety follow up phone call 1 week after end of study visit).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication. Since the same subjects progress through Weeks 1 - 8, the same subject may be counted in Week 1 - 4, Week 5 - 8, Overall Duration, and Post treatment.
|
|
Nervous system disorders
Insomnia
|
8.9%
5/56 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose administration at Baseline visit up to nine weeks (i.e., safety follow up phone call 1 week after end of study visit).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication. Since the same subjects progress through Weeks 1 - 8, the same subject may be counted in Week 1 - 4, Week 5 - 8, Overall Duration, and Post treatment.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
4/56 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose administration at Baseline visit up to nine weeks (i.e., safety follow up phone call 1 week after end of study visit).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication. Since the same subjects progress through Weeks 1 - 8, the same subject may be counted in Week 1 - 4, Week 5 - 8, Overall Duration, and Post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
3/56 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose administration at Baseline visit up to nine weeks (i.e., safety follow up phone call 1 week after end of study visit).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication. Since the same subjects progress through Weeks 1 - 8, the same subject may be counted in Week 1 - 4, Week 5 - 8, Overall Duration, and Post treatment.
|
|
General disorders
Fatigue
|
5.4%
3/56 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose administration at Baseline visit up to nine weeks (i.e., safety follow up phone call 1 week after end of study visit).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication. Since the same subjects progress through Weeks 1 - 8, the same subject may be counted in Week 1 - 4, Week 5 - 8, Overall Duration, and Post treatment.
|
|
Psychiatric disorders
Irritability
|
5.4%
3/56 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose administration at Baseline visit up to nine weeks (i.e., safety follow up phone call 1 week after end of study visit).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication. Since the same subjects progress through Weeks 1 - 8, the same subject may be counted in Week 1 - 4, Week 5 - 8, Overall Duration, and Post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
3/56 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected after the first dose administration at Baseline visit up to nine weeks (i.e., safety follow up phone call 1 week after end of study visit).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication. Since the same subjects progress through Weeks 1 - 8, the same subject may be counted in Week 1 - 4, Week 5 - 8, Overall Duration, and Post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place