Trial Outcomes & Findings for Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD) (NCT NCT02466425)
NCT ID: NCT02466425
Last Updated: 2021-06-03
Results Overview
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fourth edition - text revision (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even-numbered items 2-18) and inattentiveness (odd-numbered items 1-17). Higher score = more severe symptoms.
COMPLETED
PHASE3
264 participants
Baseline, Visit 6 (Week 4)
2021-06-03
Participant Flow
The study was conducted at 36 sites in the United States between 18 June 2015 and 16 February 2016.
A total of 338 participants were screened and 264 participants were enrolled in the study.
Participant milestones
| Measure |
Placebo
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465
Participants received SHP465 capsule (12.5 milligram \[mg\] during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
132
|
|
Overall Study
Treated
|
131
|
132
|
|
Overall Study
COMPLETED
|
118
|
116
|
|
Overall Study
NOT COMPLETED
|
14
|
16
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465
Participants received SHP465 capsule (12.5 milligram \[mg\] during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
11
|
|
Overall Study
Lack of Efficacy
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Other
|
1
|
3
|
|
Overall Study
Withdrawal by Parent/Guardian
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Placebo
n=131 Participants
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465
n=132 Participants
Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.5 Years
STANDARD_DEVIATION 3.24 • n=5 Participants
|
12.4 Years
STANDARD_DEVIATION 3.25 • n=7 Participants
|
12.5 Years
STANDARD_DEVIATION 3.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visit 6 (Week 4)Population: Full-analysis set (FAS) consisted of the safety set who had at least 1 post-dose ADHD-RS-IV total score assessment. FAS with number of participants evaluable for this outcome.
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fourth edition - text revision (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even-numbered items 2-18) and inattentiveness (odd-numbered items 1-17). Higher score = more severe symptoms.
Outcome measures
| Measure |
Placebo
n=129 Participants
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465
n=128 Participants
Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4)
Baseline
|
40.0 Units on a scale
Standard Deviation 6.96
|
39.0 Units on a scale
Standard Deviation 6.95
|
|
Change From Baseline in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4)
Change at Visit 6 (Week 4)
|
-11.7 Units on a scale
Standard Deviation 13.37
|
-21.5 Units on a scale
Standard Deviation 11.53
|
SECONDARY outcome
Timeframe: Visit 6 (Week 4)Population: FAS with number of participants evaluable for this outcome.
CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Placebo
n=117 Participants
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465
n=112 Participants
Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
|
|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I) at Visit 6 (Week 4)
|
2.9 Units on a scale
Standard Deviation 1.20
|
2.1 Units on a scale
Standard Deviation 1.13
|
Adverse Events
Placebo
SHP465
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=131 participants at risk
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465
n=132 participants at risk
Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during dose maintenance phase) orally once daily for 4 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.1%
4/131 • Number of events 5 • From start of study drug administration up to safety follow-up assessment (35 days)
|
6.8%
9/132 • Number of events 10 • From start of study drug administration up to safety follow-up assessment (35 days)
|
|
Investigations
Weight decreased
|
0.76%
1/131 • Number of events 1 • From start of study drug administration up to safety follow-up assessment (35 days)
|
5.3%
7/132 • Number of events 7 • From start of study drug administration up to safety follow-up assessment (35 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.9%
9/131 • Number of events 9 • From start of study drug administration up to safety follow-up assessment (35 days)
|
30.3%
40/132 • Number of events 44 • From start of study drug administration up to safety follow-up assessment (35 days)
|
|
Nervous system disorders
Headache
|
10.7%
14/131 • Number of events 18 • From start of study drug administration up to safety follow-up assessment (35 days)
|
12.1%
16/132 • Number of events 18 • From start of study drug administration up to safety follow-up assessment (35 days)
|
|
Psychiatric disorders
Insomnia
|
1.5%
2/131 • Number of events 2 • From start of study drug administration up to safety follow-up assessment (35 days)
|
11.4%
15/132 • Number of events 17 • From start of study drug administration up to safety follow-up assessment (35 days)
|
|
Psychiatric disorders
Irritability
|
1.5%
2/131 • Number of events 2 • From start of study drug administration up to safety follow-up assessment (35 days)
|
6.8%
9/132 • Number of events 9 • From start of study drug administration up to safety follow-up assessment (35 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER