Trial Outcomes & Findings for Effect of Vyvanse on Driving in Young Adults With ADHD (NCT NCT00801229)
NCT ID: NCT00801229
Last Updated: 2014-03-10
Results Overview
Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, "surprise events," designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo.
COMPLETED
PHASE4
75 participants
6 weeks
2014-03-10
Participant Flow
Participant milestones
| Measure |
Vyvanse
|
Placebo
|
|---|---|---|
|
Signed Consent
STARTED
|
38
|
37
|
|
Signed Consent
COMPLETED
|
35
|
34
|
|
Signed Consent
NOT COMPLETED
|
3
|
3
|
|
Received Study Drug/Placebo
STARTED
|
35
|
34
|
|
Received Study Drug/Placebo
COMPLETED
|
31
|
30
|
|
Received Study Drug/Placebo
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Vyvanse
|
Placebo
|
|---|---|---|
|
Signed Consent
Withdrawal by Subject
|
2
|
2
|
|
Signed Consent
Found Ineligible
|
1
|
1
|
|
Received Study Drug/Placebo
Elevated SGOT level
|
1
|
0
|
|
Received Study Drug/Placebo
Sub-threshold ADHD
|
0
|
1
|
|
Received Study Drug/Placebo
Simulator sickness
|
1
|
1
|
|
Received Study Drug/Placebo
Withdrawal by Subject
|
1
|
0
|
|
Received Study Drug/Placebo
Lost to Follow-up
|
0
|
1
|
|
Received Study Drug/Placebo
Adverse Event
|
1
|
1
|
Baseline Characteristics
Effect of Vyvanse on Driving in Young Adults With ADHD
Baseline characteristics by cohort
| Measure |
Vyvanse
n=35 Participants
|
Placebo
n=34 Participants
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
22.26 Years
STANDARD_DEVIATION 2.12 • n=5 Participants
|
22.15 Years
STANDARD_DEVIATION 1.99 • n=7 Participants
|
22.20 Years
STANDARD_DEVIATION 2.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Participants who completed the protocol, including endpoint Driving Simulation assessment, were analyzed (61 in total).
Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, "surprise events," designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo.
Outcome measures
| Measure |
Vyvanse
n=31 Participants
|
Placebo
n=30 Participants
|
|---|---|---|
|
Participants Experiencing Collisions During "Surprise Events" in Driving Simulator
|
8 participants
|
17 participants
|
Adverse Events
Vyvanse
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vyvanse
n=35 participants at risk
|
Placebo
n=34 participants at risk
|
|---|---|---|
|
Metabolism and nutrition disorders
Decreased Appetite
|
54.3%
19/35
|
5.9%
2/34
|
|
General disorders
Mucosal Dryness
|
25.7%
9/35
|
2.9%
1/34
|
|
General disorders
Tense/Jittery
|
22.9%
8/35
|
5.9%
2/34
|
|
General disorders
Insomnia
|
20.0%
7/35
|
2.9%
1/34
|
|
General disorders
Headaches
|
14.3%
5/35
|
2.9%
1/34
|
|
Gastrointestinal disorders
Gastrointestinal
|
8.6%
3/35
|
5.9%
2/34
|
|
Infections and infestations
Cold/Infection/Allergy
|
8.6%
3/35
|
14.7%
5/34
|
|
Psychiatric disorders
Agitated/Irritable
|
5.7%
2/35
|
0.00%
0/34
|
|
Psychiatric disorders
Sad/Down
|
5.7%
2/35
|
0.00%
0/34
|
|
General disorders
Autonomic
|
5.7%
2/35
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
5.7%
2/35
|
11.8%
4/34
|
|
Renal and urinary disorders
Genitourinary
|
5.7%
2/35
|
0.00%
0/34
|
|
General disorders
Increased Energy
|
2.9%
1/35
|
0.00%
0/34
|
|
Cardiac disorders
Cardiovascular
|
2.9%
1/35
|
2.9%
1/34
|
|
General disorders
Decreased Energy
|
0.00%
0/35
|
2.9%
1/34
|
Additional Information
Joseph Biderman, MD
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place