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Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT00735371
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : February 23, 2010
Last Update Posted : March 20, 2017
Sponsor:
Information provided by:
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder (ADHD)
Interventions Drug: LDX 30 mg
Drug: LDX 50 mg
Drug: LDX 70 mg
Drug: Placebo
Enrollment 314
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) 30 mg LDX 50 mg LDX 70 mg Placebo
Hide Arm/Group Description 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. 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. 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
Period Title: Overall Study
Started 78 79 78 79
Completed 63 66 67 69
Not Completed 15 13 11 10
Reason Not Completed
Adverse Event             3             3             4             1
Protocol Violation             2             2             0             3
Withdrawal by Subject             0             2             2             0
Lost to Follow-up             1             1             3             1
Lack of Efficacy             4             2             0             4
Sponsor Decision             3             1             0             1
Protocol Violation             0             1             2             0
Prior Vyvanse Exposure             1             1             0             0
Exclusion criteria             1             0             0             0
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) 30 mg LDX 50 mg LDX 70 mg Placebo Total
Hide Arm/Group Description 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. 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. 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 Total of all reporting groups
Overall Number of Baseline Participants 78 79 78 79 314
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 78 participants 79 participants 314 participants
<=18 years
78
 100.0%
79
 100.0%
78
 100.0%
79
 100.0%
314
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 79 participants 78 participants 79 participants 314 participants
14.6  (1.39) 14.7  (1.29) 14.4  (1.30) 14.5  (1.25) 14.6  (1.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 78 participants 79 participants 314 participants
Female
19
  24.4%
16
  20.3%
34
  43.6%
25
  31.6%
94
  29.9%
Male
59
  75.6%
63
  79.7%
44
  56.4%
54
  68.4%
220
  70.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 78 participants 79 participants 78 participants 79 participants 314 participants
78 79 78 79 314
1.Primary Outcome
Title Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 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 1, 2, 3 and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) 30 mg LDX 50 mg LDX 70 mg Placebo
Hide Arm/Group Description:
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.
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.
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
Overall Number of Participants Analyzed 78 76 78 77
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-18.3  (1.25) -21.1  (1.28) -20.7  (1.25) -12.8  (1.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX) 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0056
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LDX 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LDX 70 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
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 1, 2, 3 and 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) 30 mg LDX 50 mg LDX 70 mg Placebo
Hide Arm/Group Description:
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.
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.
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
Overall Number of Participants Analyzed 78 76 78 77
Measure Type: Number
Unit of Measure: Participants
44 53 57 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX) 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0235
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LDX 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LDX 70 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Youth Quality of Life-Research Version (YQOL-R) Total Score
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 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) 30 mg LDX 50 mg LDX 70 mg Placebo
Hide Arm/Group Description:
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.
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.
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
Overall Number of Participants Analyzed 78 76 78 77
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 79.3  (10.03) 80.5  (10.63) 78.8  (15.38) 79.2  (11.08)
4 Weeks 81.1  (11.09) 81.3  (11.86) 81.3  (14.66) 81.3  (12.16)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Population defined as all subjects who took at least one dose of study medication.
 
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) 30 mg LDX 50 mg LDX 70 mg Placebo
Hide Arm/Group Description 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. 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. 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
All-Cause Mortality
Lisdexamfetamine Dimesylate (LDX) 30 mg LDX 50 mg LDX 70 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lisdexamfetamine Dimesylate (LDX) 30 mg LDX 50 mg LDX 70 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/77 (0.00%)   0/78 (0.00%)   0/77 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lisdexamfetamine Dimesylate (LDX) 30 mg LDX 50 mg LDX 70 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/78 (65.38%)   53/77 (68.83%)   56/78 (71.79%)   38/77 (49.35%) 
Gastrointestinal disorders         
Nausea  1/78 (1.28%)  3/77 (3.90%)  5/78 (6.41%)  2/77 (2.60%) 
Vomiting  0/78 (0.00%)  1/77 (1.30%)  2/78 (2.56%)  4/77 (5.19%) 
Dry mouth  0/78 (0.00%)  6/77 (7.79%)  4/78 (5.13%)  1/77 (1.30%) 
General disorders         
Irritability  6/78 (7.69%)  2/77 (2.60%)  8/78 (10.26%)  3/77 (3.90%) 
Fatigue  4/78 (5.13%)  2/77 (2.60%)  4/78 (5.13%)  2/77 (2.60%) 
Infections and infestations         
Upper respiratory tract infection  2/78 (2.56%)  4/77 (5.19%)  4/78 (5.13%)  6/77 (7.79%) 
Nasopharyngitis  2/78 (2.56%)  4/77 (5.19%)  1/78 (1.28%)  1/77 (1.30%) 
Investigations         
Weight decreased  3/78 (3.85%)  7/77 (9.09%)  12/78 (15.38%)  0/77 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  29/78 (37.18%)  21/77 (27.27%)  29/78 (37.18%)  2/77 (2.60%) 
Nervous system disorders         
Headache  9/78 (11.54%)  13/77 (16.88%)  12/78 (15.38%)  10/77 (12.99%) 
Dizziness  1/78 (1.28%)  4/77 (5.19%)  5/78 (6.41%)  3/77 (3.90%) 
Psychiatric disorders         
Insomnia  7/78 (8.97%)  8/77 (10.39%)  11/78 (14.10%)  3/77 (3.90%) 
Respiratory, thoracic and mediastinal disorders         
Nasal congestion  1/78 (1.28%)  0/77 (0.00%)  5/78 (6.41%)  1/77 (1.30%) 
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
Name/Title: Timothy Whitaker, MD
Organization: Shire Pharmaceuticals
Responsible Party: Timothy Whitaker, MD/Clinical Research & Development -VP of Global Clinical Medicine, Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00735371     History of Changes
Other Study ID Numbers: SPD489-305
First Submitted: August 12, 2008
First Posted: August 14, 2008
Results First Submitted: February 1, 2010
Results First Posted: February 23, 2010
Last Update Posted: March 20, 2017