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Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01552902
First received: March 6, 2012
Last updated: March 4, 2015
Last verified: June 2014
History of Changes
Results First Received: March 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention-deficit/Hyperactivity Disorder
Interventions: Drug: Lisdexamfetamine dimesylate
Drug: Methylphenidate Hydrochloride
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 77 sites in the United States, Canada, and Europe.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 778 screened participants, 229 were screen failures and 549 were randomized to treatment. A total of 547 participants were treated and the reasons for 2 'randomized but not treated' participants included withdrawal by 1 participant in the Methylphenidate group and 1 participant with a protocol violation in the Lisdexamfetamine group.

Reporting Groups
  Description
Placebo 2 placebo over encapsulated capsules once daily orally for 6 weeks.
Lisdexamfetamine Dimesylate Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 milligram (mg) over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
Methylphenidate Methylphenidate (Concerta, Osmotic controlled oral release delivery system-methylphenidate [OROS-MPH]) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).

Participant Flow:   Overall Study
    Placebo   Lisdexamfetamine Dimesylate   Methylphenidate
STARTED   110   218   219 
COMPLETED   97   181   186 
NOT COMPLETED   13   37   33 
Adverse Event                1                15                14 
Protocol Violation                3                3                3 
Lack of Efficacy                4                3                1 
Withdrawal by Subject                1                9                6 
Lost to Follow-up                1                3                6 
Unspecified                3                4                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety set consisted of all participants in the Randomized set (all screened participants for whom a randomization number was generated) who took at least 1 dose of investigational product.

Reporting Groups
  Description
Placebo 2 placebo over encapsulated capsules once daily orally for 6 weeks.
Lisdexamfetamine Dimesylate Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
Methylphenidate Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
Total Total of all reporting groups

Baseline Measures
   Placebo   Lisdexamfetamine Dimesylate   Methylphenidate   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 110   218   219   547 
Age [1] 
[Units: Participants]
 		       
<=18 years   110   218   219   547 
Between 18 and 65 years   0   0   0   0 
>=65 years   0   0   0   0 
[1] Age was calculated as the difference between date of birth and date of informed consent.
Age [1] 
[Units: Years]
Mean (Standard Deviation) 		 14.7  (1.37)   14.6  (1.38)   14.7  (1.42)   14.7  (1.40) 
[1] Age was calculated as the difference between date of birth and date of informed consent.
Gender 
[Units: Participants]
 		       
Female   34   83   69   186 
Male   76   135   150   361 
Attention-deficit/Hyperactivity Disorder (ADHD) Subtype 
[Units: Participants]
 		       
Predominantly Inattentive   40   70   71   181 
Predominantly Hyperactive/Impulsive   2   2   4   8 
Combined Subtype   68   146   144   358 
Clinical Global Impressions – Severity of Illness (CGI-S) [1] 
[Units: Participants]
 		       
Borderline mentally ill   1   0   0   1 
Mildly ill   2   4   1   7 
Moderately ill   60   93   115   268 
Markedly ill   41   106   90   237 
Severely ill   6   15   13   34 
[1] The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale includes a severity of illness item and a global improvement item. The investigator performed the CGI-S to rate the severity of a participant's condition on a 7-point scale (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill).
Attention-deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 36.1  (5.91)   37.2  (6.46)   36.9  (6.42)   36.9  (6.34) 
[1] The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.


  Outcome Measures
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1.  Primary:   Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6   [ Time Frame: Baseline, Week 6 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6   [ Time Frame: Week 6 ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs   [ Time Frame: Baseline up to 3 days after last dose (last dose at Week 6) ]
  Show Outcome Measure 3

4.  Other Pre-specified:   Change From Baseline in Blood Pressure at Week 6   [ Time Frame: Baseline, Week 6 ]
  Show Outcome Measure 4

5.  Other Pre-specified:   Change From Baseline in Pulse Rate at Week 6   [ Time Frame: Baseline, Week 6 ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire
phone: 1 866-842-5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01552902     History of Changes
Other Study ID Numbers: SPD489-406
2011-005452-34 ( EudraCT Number )
Study First Received: March 6, 2012
Results First Received: March 4, 2015
Last Updated: March 4, 2015