Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 110 for:    nrp 104 OR lisdexamfetamine

Effect of Vyvanse on Driving in Young Adults With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00801229
Recruitment Status : Completed
First Posted : December 3, 2008
Results First Posted : August 25, 2011
Last Update Posted : March 10, 2014
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Attention Deficit/Hyperactivity Disorder(ADHD)
Interventions Drug: Vyvanse
Drug: Placebo
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vyvanse Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Signed Consent
Started 38 37
Completed 35 34
Not Completed 3 3
Reason Not Completed
Withdrawal by Subject             2             2
Found Ineligible             1             1
Period Title: Received Study Drug/Placebo
Started 35 34
Completed 31 30
Not Completed 4 4
Reason Not Completed
Elevated SGOT level             1             0
Sub-threshold ADHD             0             1
Simulator sickness             1             1
Withdrawal by Subject             1             0
Lost to Follow-up             0             1
Adverse Event             1             1
Arm/Group Title Vyvanse Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 35 34 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 34 participants 69 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
 100.0%
34
 100.0%
69
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 34 participants 69 participants
22.26  (2.12) 22.15  (1.99) 22.20  (2.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 34 participants 69 participants
Female
14
  40.0%
16
  47.1%
30
  43.5%
Male
21
  60.0%
18
  52.9%
39
  56.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 34 participants 69 participants
35 34 69
1.Primary Outcome
Title Participants Experiencing Collisions During "Surprise Events" in Driving Simulator
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol, including endpoint Driving Simulation assessment, were analyzed (61 in total).
Arm/Group Title Vyvanse Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 30
Measure Type: Number
Unit of Measure: participants
8 17
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vyvanse Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Vyvanse Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vyvanse Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Vyvanse Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   30/35 (85.71%)   20/34 (58.82%) 
Cardiac disorders     
Cardiovascular   1/35 (2.86%)  1/34 (2.94%) 
Gastrointestinal disorders     
Gastrointestinal   3/35 (8.57%)  2/34 (5.88%) 
General disorders     
Mucosal Dryness   9/35 (25.71%)  1/34 (2.94%) 
Tense/Jittery   8/35 (22.86%)  2/34 (5.88%) 
Insomnia   7/35 (20.00%)  1/34 (2.94%) 
Headaches   5/35 (14.29%)  1/34 (2.94%) 
Autonomic   2/35 (5.71%)  0/34 (0.00%) 
Increased Energy   1/35 (2.86%)  0/34 (0.00%) 
Decreased Energy   0/35 (0.00%)  1/34 (2.94%) 
Infections and infestations     
Cold/Infection/Allergy   3/35 (8.57%)  5/34 (14.71%) 
Metabolism and nutrition disorders     
Decreased Appetite   19/35 (54.29%)  2/34 (5.88%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal   2/35 (5.71%)  4/34 (11.76%) 
Psychiatric disorders     
Agitated/Irritable   2/35 (5.71%)  0/34 (0.00%) 
Sad/Down   2/35 (5.71%)  0/34 (0.00%) 
Renal and urinary disorders     
Genitourinary   2/35 (5.71%)  0/34 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joseph Biderman, MD
Organization: Massachusetts General Hospital
Phone: 617-726-1746
Layout table for additonal information
Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00801229     History of Changes
Other Study ID Numbers: 2008P000971
First Submitted: December 2, 2008
First Posted: December 3, 2008
Results First Submitted: June 20, 2011
Results First Posted: August 25, 2011
Last Update Posted: March 10, 2014