Trial Outcomes & Findings for Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD) (NCT NCT02604407)
NCT ID: NCT02604407
Last Updated: 2021-06-03
Results Overview
The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.
COMPLETED
PHASE3
275 participants
Baseline, Visit 6 (Week 4)
2021-06-03
Participant Flow
The study was conducted at 43 study centers in the United States between 19 November 2015 and 24 March 2016.
A total of 369 participants were screened and 275 participants were enrolled in the study.
Participant milestones
| Measure |
Placebo
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465 12.5 mg
Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
|
SHP465 37.5 mg
Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
92
|
92
|
|
Overall Study
TREATED
|
89
|
92
|
90
|
|
Overall Study
COMPLETED
|
80
|
80
|
76
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
16
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465 12.5 mg
Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
|
SHP465 37.5 mg
Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
7
|
5
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Other
|
3
|
1
|
4
|
Baseline Characteristics
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Placebo
n=89 Participants
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465 12.5 mg
n=92 Participants
Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
|
SHP465 37.5 mg
n=90 Participants
Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.5 Years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
33 Years
STANDARD_DEVIATION 10.40 • n=7 Participants
|
32.4 Years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
33.3 Years
STANDARD_DEVIATION 10.40 • n=4 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visit 6 (Week 4)Population: Full Analysis Set (FAS) consisted of all participants in the safety set who had at least 1 post dose baseline primary efficacy assessment (ADHD-RS with prompt total score) on treatment.
The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.
Outcome measures
| Measure |
Placebo
n=86 Participants
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465 12.5 mg
n=89 Participants
Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
|
SHP465 37.5 mg
n=88 Participants
Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
|
|---|---|---|---|
|
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)
Baseline
|
40.5 Units on a scale
Standard Deviation 6.52
|
39.8 Units on a scale
Standard Deviation 6.38
|
39.9 Units on a scale
Standard Deviation 7.07
|
|
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)
Change at Visit 6
|
-11.0 Units on a scale
Standard Deviation 11.47
|
-18.1 Units on a scale
Standard Deviation 13.42
|
-23.8 Units on a scale
Standard Deviation 11.89
|
SECONDARY outcome
Timeframe: Visit 6 (Week 4)Population: Full-analysis set (FAS) consisted of all participants in the safety set who had at least 1 postdose baseline primary efficacy assessment (ADHD-RS with prompt total score) on treatment with number of participants evaluable for this outcome.
CGI scales permit a global evaluation of the participant's severity and improvement over time. CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Outcome measures
| Measure |
Placebo
n=77 Participants
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465 12.5 mg
n=78 Participants
Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
|
SHP465 37.5 mg
n=73 Participants
Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
|
|---|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)
|
3.1 Units on a scale
Standard Deviation 1.05
|
2.4 Units on a scale
Standard Deviation 1.16
|
1.9 Units on a scale
Standard Deviation 1.10
|
Adverse Events
Placebo
SHP465 12.5 mg
SHP465 37.5 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=89 participants at risk
Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
|
SHP465 12.5 mg
n=92 participants at risk
Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
|
SHP465 37.5 mg
n=90 participants at risk
Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
3/89 • Number of events 3 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
14.1%
13/92 • Number of events 13 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
22.2%
20/90 • Number of events 20 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
4/89 • Number of events 4 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
19.6%
18/92 • Number of events 18 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
30.0%
27/90 • Number of events 27 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
|
Nervous system disorders
Headache
|
4.5%
4/89 • Number of events 4 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
6.5%
6/92 • Number of events 6 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
12.2%
11/90 • Number of events 11 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
|
Psychiatric disorders
Anxiety
|
1.1%
1/89 • Number of events 1 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
6.5%
6/92 • Number of events 7 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
4.4%
4/90 • Number of events 4 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/89 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
1.1%
1/92 • Number of events 1 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
5.6%
5/90 • Number of events 5 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
|
Psychiatric disorders
Initial insomnia
|
1.1%
1/89 • Number of events 1 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
4.3%
4/92 • Number of events 4 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
6.7%
6/90 • Number of events 6 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/89 • Number of events 1 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
13.0%
12/92 • Number of events 12 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
11.1%
10/90 • Number of events 13 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
|
Psychiatric disorders
Irritability
|
0.00%
0/89 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
5.4%
5/92 • Number of events 6 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
3.3%
3/90 • Number of events 3 • From the Start of Study Drug Administration up to Follow-up (Week 5)
|
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