Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

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: NCT00764868
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : March 28, 2011
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition ADHD
Intervention Drug: Lisdexamfetamine Dimesylate (LDX)
Enrollment 269
Recruitment Details Subjects had to have satisfied all entry criteria for the antecedent study (SPD489-305, NCT00735371) and completed a minimum of 3 weeks of double-blind treatment and reached Visit 3 of the antecedent study (SPD489-305), without experiencing any clinically significant adverse events that would preclude exposure to LDX.
Pre-assignment Details 269 subjects were enrolled, but 4 were not dosed during the study and thus excluded from the Safety Population.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX)
Hide Arm/Group Description Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
Period Title: Overall Study
Started 269
Completed 156
Not Completed 113
Reason Not Completed
Adverse Event             18
Withdrawal by Subject             31
Non-compliance             16
Lost to Follow-up             25
Lack of Efficacy             5
Subject moved             7
Pregnancy             3
Prohibited medication             1
Out of town             1
Misuse and compliance of study drug             1
Subject sent to boarding school             1
Met an exclusion criteria             1
Positive drug screen             2
Sponsor requested withdrawal             1
Arm/Group Title Lisdexamfetamine Dimesylate (LDX)
Hide Arm/Group Description Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
Overall Number of Baseline Participants 265
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 265 participants
14.5  (1.30)
[1]
Measure Description: Baseline characteristics were calculated from the Safety Population (n = 265) defined as all randomized subjects who received at least 1 dose of investigational product. Baseline and demographic characteristics are calculated from entry into the antecedent study (SPD489-305, NCT00735371).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 265 participants
13 to 14 years 144
15 to 17 years 121
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 265 participants
Female
78
  29.4%
Male
187
  70.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 265 participants
265
1.Primary Outcome
Title Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks
Hide Description 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.
Time Frame Baseline and up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of investigational product and have a valid baseline and at least 1 valid follow-up assessment of the primary outcome measure.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX)
Hide Arm/Group Description:
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
Overall Number of Participants Analyzed 265
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-26.2  (9.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments t-test of LDX at baseline and 52 weeks
2.Secondary Outcome
Title Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)
Hide Description 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.
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX)
Hide Arm/Group Description:
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
Overall Number of Participants Analyzed 265
Measure Type: Number
Unit of Measure: Percent of participants
87.2
3.Secondary Outcome
Title Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks
Hide Description 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.
Time Frame Baseline and Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX)
Hide Arm/Group Description:
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
Overall Number of Participants Analyzed 237
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.9  (9.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments t-test of LDX at baseline and 52 weeks
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
 
Arm/Group Title Lisdexamfetamine Dimesylate (LDX)
Hide Arm/Group Description Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
All-Cause Mortality
Lisdexamfetamine Dimesylate (LDX)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lisdexamfetamine Dimesylate (LDX)
Affected / at Risk (%) # Events
Total   10/265 (3.77%)    
Congenital, familial and genetic disorders   
Hydrocele  1/265 (0.38%)  1
Infections and infestations   
Pneumonia  1/265 (0.38%)  1
Injury, poisoning and procedural complications   
Joint Sprain  1/265 (0.38%)  1
Pelvic Fracture  1/265 (0.38%)  1
Traumatic Liver Injury  1/265 (0.38%)  1
Wrist Fracture  1/265 (0.38%)  1
Nervous system disorders   
Syncope  3/265 (1.13%)  4
Syncope Vasovagal  1/265 (0.38%)  1
Pregnancy, puerperium and perinatal conditions   
Ectopic Pregnancy  1/265 (0.38%)  1
Psychiatric disorders   
Aggression  2/265 (0.75%)  2
Reproductive system and breast disorders   
Testicular Torsion  1/265 (0.38%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lisdexamfetamine Dimesylate (LDX)
Affected / at Risk (%) # Events
Total   230/265 (86.79%)    
Gastrointestinal disorders   
Dry Mouth  14/265 (5.28%)  15
General disorders   
Irritability  33/265 (12.45%)  36
Infections and infestations   
Influenza  18/265 (6.79%)  18
Nasopharyngitis  19/265 (7.17%)  26
Upper Respiratory Tract Infection  58/265 (21.89%)  74
Investigations   
Weight Decreased  43/265 (16.23%)  46
Metabolism and nutrition disorders   
Decreased Appetite  56/265 (21.13%)  71
Nervous system disorders   
Dizziness  14/265 (5.28%)  16
Headache  55/265 (20.75%)  81
Psychiatric disorders   
Insomnia  32/265 (12.08%)  43
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Timothy Whitaker, MD
Organization: Shire Pharmaceutical
EMail: twhitaker@shire.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00764868    
Other Study ID Numbers: SPD489-306
First Submitted: September 29, 2008
First Posted: October 2, 2008
Results First Submitted: January 31, 2011
Results First Posted: March 28, 2011
Last Update Posted: February 7, 2014