Trial Outcomes & Findings for Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder (NCT NCT01552915)
NCT ID: NCT01552915
Last Updated: 2021-06-08
Results Overview
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
464 participants
Primary outcome timeframe
Baseline and week 8
Results posted on
2021-06-08
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
|
SPD489
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day
|
OROS-MPH
Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
184
|
184
|
|
Overall Study
COMPLETED
|
68
|
155
|
157
|
|
Overall Study
NOT COMPLETED
|
23
|
29
|
27
|
Reasons for withdrawal
| Measure |
Placebo
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
|
SPD489
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day
|
OROS-MPH
Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
14
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
5
|
|
Overall Study
Protocol Violation
|
0
|
4
|
4
|
|
Overall Study
Lack of Efficacy
|
8
|
1
|
4
|
|
Overall Study
Other
|
2
|
0
|
6
|
Baseline Characteristics
Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=91 Participants
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
|
SPD489
n=184 Participants
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
|
OROS-MPH
n=184 Participants
Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
|
Total
n=459 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.8 Years
STANDARD_DEVIATION 1.43 • n=5 Participants
|
14.7 Years
STANDARD_DEVIATION 1.38 • n=7 Participants
|
14.7 Years
STANDARD_DEVIATION 1.32 • n=5 Participants
|
14.7 Years
STANDARD_DEVIATION 1.37 • n=4 Participants
|
|
Age, Customized
<=18 years
|
91 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
459 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
305 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
91 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
459 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 8Population: Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.
Outcome measures
| Measure |
Placebo
n=89 Participants
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
|
SPD489
n=179 Participants
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
|
OROS-MPH
n=184 Participants
Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
|
|---|---|---|---|
|
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8
|
-13.4 units on a scale
Standard Error 1.19
|
-25.6 units on a scale
Standard Error 0.82
|
-23.5 units on a scale
Standard Error 0.80
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Outcome measures
| Measure |
Placebo
n=89 Participants
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
|
SPD489
n=178 Participants
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
|
OROS-MPH
n=184 Participants
Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
|
|---|---|---|---|
|
Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)
|
34.8 percentage of participants
|
83.1 percentage of participants
|
81.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to 8 WeeksPopulation: Safety Set: All randomized subjects who took at least 1 dose of investigational product.
Outcome measures
| Measure |
Placebo
n=89 Participants
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
|
SPD489
n=179 Participants
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
|
OROS-MPH
n=184 Participants
Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
|
-0.8 mmHg
Standard Deviation 8.97
|
2.4 mmHg
Standard Deviation 9.46
|
0.4 mmHg
Standard Deviation 9.90
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Safety Set: All randomized subjects who took at least 1 dose of investigational product.
Outcome measures
| Measure |
Placebo
n=89 Participants
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
|
SPD489
n=179 Participants
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
|
OROS-MPH
n=184 Participants
Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
|
|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
|
-1.2 mmHg
Standard Deviation 8.11
|
2.8 mmHg
Standard Deviation 8.41
|
2.2 mmHg
Standard Deviation 8.64
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Safety Set: All randomized subjects who took at least 1 dose of investigational product.
Outcome measures
| Measure |
Placebo
n=89 Participants
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
|
SPD489
n=179 Participants
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
|
OROS-MPH
n=184 Participants
Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment
|
0.3 bpm
Standard Deviation 11.32
|
4.7 bpm
Standard Deviation 11.82
|
6.0 bpm
Standard Deviation 10.52
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
SPD489
Serious events: 1 serious events
Other events: 139 other events
Deaths: 0 deaths
OROS-MPH
Serious events: 1 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=91 participants at risk
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
|
SPD489
n=184 participants at risk
Subjects received over encapsulated SPD489 optimized among a 30, 50, or 70mg dose.
|
OROS-MPH
n=184 participants at risk
Subjects received over encapsulated OROS-MPH optimized among a 18, 36, 54 or 72mg dose. Subjects optimized to 72mg received two 36mg tablets.
|
|---|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/91 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
0.54%
1/184 • Number of events 1 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
0.00%
0/184 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/91 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
0.00%
0/184 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
0.54%
1/184 • Number of events 1 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
Other adverse events
| Measure |
Placebo
n=91 participants at risk
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
|
SPD489
n=184 participants at risk
Subjects received over encapsulated SPD489 optimized among a 30, 50, or 70mg dose.
|
OROS-MPH
n=184 participants at risk
Subjects received over encapsulated OROS-MPH optimized among a 18, 36, 54 or 72mg dose. Subjects optimized to 72mg received two 36mg tablets.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.4%
4/91 • Number of events 6 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
6.5%
12/184 • Number of events 12 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
5.4%
10/184 • Number of events 13 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Dry mouth
|
1.1%
1/91 • Number of events 1 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
8.2%
15/184 • Number of events 17 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
6.0%
11/184 • Number of events 11 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
4.4%
4/91 • Number of events 4 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
7.6%
14/184 • Number of events 14 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
8.2%
15/184 • Number of events 17 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
General disorders
Fatigue
|
3.3%
3/91 • Number of events 3 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
5.4%
10/184 • Number of events 10 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
2.7%
5/184 • Number of events 5 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
General disorders
Irritability
|
9.9%
9/91 • Number of events 9 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
20.1%
37/184 • Number of events 41 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
7.6%
14/184 • Number of events 17 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/91 • Number of events 1 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
6.0%
11/184 • Number of events 12 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
7.1%
13/184 • Number of events 13 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
8/91 • Number of events 9 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
4.9%
9/184 • Number of events 9 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
3.3%
6/184 • Number of events 6 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Investigations
Heart rate increased
|
0.00%
0/91 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
4.3%
8/184 • Number of events 8 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
6.0%
11/184 • Number of events 12 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Investigations
Weight decreased
|
1.1%
1/91 • Number of events 1 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
20.1%
37/184 • Number of events 43 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
13.0%
24/184 • Number of events 26 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
7/91 • Number of events 8 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
53.3%
98/184 • Number of events 118 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
41.8%
77/184 • Number of events 85 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Dizziness
|
1.1%
1/91 • Number of events 1 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
6.5%
12/184 • Number of events 13 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
4.3%
8/184 • Number of events 9 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Headache
|
7.7%
7/91 • Number of events 8 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
15.2%
28/184 • Number of events 38 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
15.2%
28/184 • Number of events 35 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Somnolence
|
4.4%
4/91 • Number of events 5 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
5.4%
10/184 • Number of events 10 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
3.3%
6/184 • Number of events 6 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Initial insomnia
|
2.2%
2/91 • Number of events 2 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
8.2%
15/184 • Number of events 17 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
6.5%
12/184 • Number of events 16 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/91 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
8.7%
16/184 • Number of events 17 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
8.2%
15/184 • Number of events 15 • Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
|
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