Trial Outcomes & Findings for Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT00735371)
NCT ID: NCT00735371
Last Updated: 2021-06-14
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
314 participants
Primary outcome timeframe
Baseline and 1, 2, 3 and 4 weeks
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
Lisdexamfetamine Dimesylate (LDX) 30 mg
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 50 mg
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 70 mg
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
78
|
79
|
78
|
79
|
|
Overall Study
COMPLETED
|
63
|
66
|
67
|
69
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
11
|
10
|
Reasons for withdrawal
| Measure |
Lisdexamfetamine Dimesylate (LDX) 30 mg
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 50 mg
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 70 mg
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
4
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
2
|
0
|
4
|
|
Overall Study
Sponsor Decision
|
3
|
1
|
0
|
1
|
|
Overall Study
Prior Vyvanse Exposure
|
1
|
1
|
0
|
0
|
|
Overall Study
Exclusion criteria
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Lisdexamfetamine Dimesylate (LDX) 30 mg
n=78 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 50 mg
n=79 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 70 mg
n=78 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
Placebo
n=79 Participants
Placebo
|
Total
n=314 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
78 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
314 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
14.6 years
STANDARD_DEVIATION 1.39 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 1.29 • n=7 Participants
|
14.4 years
STANDARD_DEVIATION 1.30 • n=5 Participants
|
14.5 years
STANDARD_DEVIATION 1.25 • n=4 Participants
|
14.6 years
STANDARD_DEVIATION 1.31 • n=21 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
220 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
78 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
314 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1, 2, 3 and 4 weeksPopulation: Full Analysis Set (FAS) is defined as all subjects who took at least one dose of study medication and had a valid Baseline and at least one post-Baseline follow-up assessment of the primary outcome measure (ADHD-RS-IV Total Score)
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.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX) 30 mg
n=78 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 50 mg
n=76 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 70 mg
n=78 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
Placebo
n=77 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks
|
-18.3 Units on a scale
Standard Error 1.25
|
-21.1 Units on a scale
Standard Error 1.28
|
-20.7 Units on a scale
Standard Error 1.25
|
-12.8 Units on a scale
Standard Error 1.25
|
SECONDARY outcome
Timeframe: 1, 2, 3 and 4 WeeksPopulation: FAS
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 |
Lisdexamfetamine Dimesylate (LDX) 30 mg
n=78 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 50 mg
n=76 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 70 mg
n=78 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
Placebo
n=77 Participants
Placebo
|
|---|---|---|---|---|
|
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
|
44 Participants
|
53 Participants
|
57 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: FAS
The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX) 30 mg
n=78 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 50 mg
n=76 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 70 mg
n=78 Participants
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
Placebo
n=77 Participants
Placebo
|
|---|---|---|---|---|
|
Youth Quality of Life-Research Version (YQOL-R) Total Score
Baseline
|
79.3 Units on a scale
Standard Deviation 10.03
|
80.5 Units on a scale
Standard Deviation 10.63
|
78.8 Units on a scale
Standard Deviation 15.38
|
79.2 Units on a scale
Standard Deviation 11.08
|
|
Youth Quality of Life-Research Version (YQOL-R) Total Score
4 Weeks
|
81.1 Units on a scale
Standard Deviation 11.09
|
81.3 Units on a scale
Standard Deviation 11.86
|
81.3 Units on a scale
Standard Deviation 14.66
|
81.3 Units on a scale
Standard Deviation 12.16
|
Adverse Events
Lisdexamfetamine Dimesylate (LDX) 30 mg
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
LDX 50 mg
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
LDX 70 mg
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lisdexamfetamine Dimesylate (LDX) 30 mg
n=78 participants at risk
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 50 mg
n=77 participants at risk
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
LDX 70 mg
n=78 participants at risk
Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
|
Placebo
n=77 participants at risk
Placebo
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.2%
29/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
27.3%
21/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
37.2%
29/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
2.6%
2/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
11.5%
9/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
16.9%
13/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
15.4%
12/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
13.0%
10/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
9.0%
7/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
10.4%
8/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
14.1%
11/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
3.9%
3/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
Investigations
Weight decreased
|
3.8%
3/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
9.1%
7/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
15.4%
12/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
0.00%
0/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
General disorders
Irritability
|
7.7%
6/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
2.6%
2/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
10.3%
8/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
3.9%
3/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
General disorders
Fatigue
|
5.1%
4/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
2.6%
2/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
5.1%
4/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
2.6%
2/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
1.3%
1/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
5.2%
4/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
6.4%
5/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
3.9%
3/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
2/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
5.2%
4/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
5.1%
4/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
7.8%
6/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
3.9%
3/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
6.4%
5/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
2.6%
2/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
1.3%
1/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
2.6%
2/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
5.2%
4/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
7.8%
6/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
5.1%
4/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
1.3%
1/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
2/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
5.2%
4/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
1.3%
1/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
1.3%
1/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.3%
1/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
0.00%
0/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
6.4%
5/78
Safety Population defined as all subjects who took at least one dose of study medication.
|
1.3%
1/77
Safety Population defined as all subjects who took at least one dose of study medication.
|
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