Trial Outcomes & Findings for A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD) (NCT NCT00500149)
NCT ID: NCT00500149
Last Updated: 2021-06-14
Results Overview
The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal).
COMPLETED
PHASE3
129 participants
Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.
2021-06-14
Participant Flow
129 subjects were enrolled for dose optimization phase, 12 discontinued, and 117 were randomized to the cross-over phase.
The study consisted of an open-label dose-optimization phase (4 weeks), followed by a randomized, placebo-controlled, 2-way crossover phase (1 week each).
Participant milestones
| Measure |
Vyvanse First
Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the first intervention and matching placebo was given orally once daily for 1 week in the second intervention
|
Placebo First
Matching placebo was given orally once daily for 1 week in the first intervention and Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the second intervention
|
|---|---|---|
|
Enrolled (Dose-optimization Phase)
STARTED
|
129
|
0
|
|
Enrolled (Dose-optimization Phase)
COMPLETED
|
117
|
0
|
|
Enrolled (Dose-optimization Phase)
NOT COMPLETED
|
12
|
0
|
|
First Intervention (Cross-over Phase)
STARTED
|
58
|
59
|
|
First Intervention (Cross-over Phase)
COMPLETED
|
56
|
57
|
|
First Intervention (Cross-over Phase)
NOT COMPLETED
|
2
|
2
|
|
Second Intervention (Cross-over Phase)
STARTED
|
56
|
57
|
|
Second Intervention (Cross-over Phase)
COMPLETED
|
54
|
57
|
|
Second Intervention (Cross-over Phase)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Vyvanse First
Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the first intervention and matching placebo was given orally once daily for 1 week in the second intervention
|
Placebo First
Matching placebo was given orally once daily for 1 week in the first intervention and Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the second intervention
|
|---|---|---|
|
Enrolled (Dose-optimization Phase)
Withdrawal by Subject
|
3
|
0
|
|
Enrolled (Dose-optimization Phase)
Adverse Event
|
8
|
0
|
|
Enrolled (Dose-optimization Phase)
Protocol Violation
|
1
|
0
|
|
First Intervention (Cross-over Phase)
Adverse Event
|
0
|
1
|
|
First Intervention (Cross-over Phase)
Withdrawal by Subject
|
1
|
1
|
|
First Intervention (Cross-over Phase)
Protocol Violation
|
1
|
0
|
|
Second Intervention (Cross-over Phase)
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=129 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
129 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
10.1 years
STANDARD_DEVIATION 1.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
129 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.Population: Analysis on the intention-to-treat (ITT) population.
The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal).
Outcome measures
| Measure |
Vyvanse
n=113 Participants
Lisdexamfetamine dimesylate (LDX)
|
Placebo
n=113 Participants
Matching placebo
|
|---|---|---|
|
Onset of Effect of Vyvanse
1.5 hours
|
0.70 scores on a scale
Standard Error 0.09
|
1.14 scores on a scale
Standard Error 0.09
|
|
Onset of Effect of Vyvanse
2.5 hours
|
0.45 scores on a scale
Standard Error 0.09
|
1.42 scores on a scale
Standard Error 0.09
|
|
Onset of Effect of Vyvanse
5 hours
|
0.44 scores on a scale
Standard Error 0.10
|
1.60 scores on a scale
Standard Error 0.10
|
|
Onset of Effect of Vyvanse
7.5 hours
|
0.54 scores on a scale
Standard Error 0.09
|
1.56 scores on a scale
Standard Error 0.09
|
|
Onset of Effect of Vyvanse
10 hours
|
0.60 scores on a scale
Standard Error 0.09
|
1.43 scores on a scale
Standard Error 0.09
|
|
Onset of Effect of Vyvanse
12 hours
|
0.90 scores on a scale
Standard Error 0.10
|
1.41 scores on a scale
Standard Error 0.10
|
|
Onset of Effect of Vyvanse
13 hours
|
1.05 scores on a scale
Standard Error 0.10
|
1.31 scores on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.Population: Analysis on intention-to-treat (ITT) population.
Duration of effect will be defined as the first time point at which there is a non-significant difference between Vyvanse and placebo after a time point at which there is a significant difference between the two treatment groups as measured by SKAMP Deportment Scores. The degree of impairment is rated from 0 (normal) to 6 (maximal).
Outcome measures
| Measure |
Vyvanse
n=113 Participants
Lisdexamfetamine dimesylate (LDX)
|
Placebo
n=113 Participants
Matching placebo
|
|---|---|---|
|
Duration of Effect of Vyvanse
10 hours
|
0.60 scores on a scale
Standard Error 0.09
|
1.43 scores on a scale
Standard Error 0.09
|
|
Duration of Effect of Vyvanse
1.5 hours
|
0.70 scores on a scale
Standard Error 0.09
|
1.14 scores on a scale
Standard Error 0.09
|
|
Duration of Effect of Vyvanse
2.5 hours
|
0.45 scores on a scale
Standard Error 0.09
|
1.42 scores on a scale
Standard Error 0.09
|
|
Duration of Effect of Vyvanse
5 hours
|
0.44 scores on a scale
Standard Error 0.10
|
1.60 scores on a scale
Standard Error 0.10
|
|
Duration of Effect of Vyvanse
7.5 hours
|
0.54 scores on a scale
Standard Error 0.09
|
1.56 scores on a scale
Standard Error 0.09
|
|
Duration of Effect of Vyvanse
12 hours
|
0.90 scores on a scale
Standard Error 0.10
|
1.41 scores on a scale
Standard Error 0.10
|
|
Duration of Effect of Vyvanse
13 hours
|
1.05 scores on a scale
Standard Error 0.10
|
1.31 scores on a scale
Standard Error 0.10
|
Adverse Events
Vyvanse
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vyvanse
n=115 participants at risk
|
Placebo
n=115 participants at risk
|
|---|---|---|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.1%
7/115
The Randomized Population is defined as all subjects who are randomized and received at least one dose of study medication during the Cross-Over Phase of the study.
|
0.87%
1/115
The Randomized Population is defined as all subjects who are randomized and received at least one dose of study medication during the Cross-Over Phase of the study.
|
|
Nervous system disorders
Headache
|
5.2%
6/115
The Randomized Population is defined as all subjects who are randomized and received at least one dose of study medication during the Cross-Over Phase of the study.
|
1.7%
2/115
The Randomized Population is defined as all subjects who are randomized and received at least one dose of study medication during the Cross-Over Phase of the study.
|
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