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Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01081145
First received: March 3, 2010
Last updated: November 25, 2014
Last verified: May 2014
History of Changes
Results First Received: May 9, 2014  
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: Extended-release Guanfacine Hydrochloride
Other: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Guanfacine Hydrochloride Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
Placebo Administered as a once-daily oral dose

Participant Flow for 2 periods

 Period 1:   Open-Label Phase
    Guanfacine Hydrochloride   Placebo
STARTED   528   0 
COMPLETED   316   0 
NOT COMPLETED   212   0 
Lack of Efficacy                56                0 
Response criteria not met                46                0 
Adverse Event                42                0 
Withdrawal by Subject                41                0 
Not specified                12                0 
Lost to Follow-up                11                0 
Protocol Violation                4                0 

Period 2:   Double-Blind Randomized-Withdrawal Phase
    Guanfacine Hydrochloride   Placebo
STARTED   157   159 
COMPLETED   76   53 
NOT COMPLETED   81   106 
Adverse Event                3                2 
Protocol Violation                1                0 
Withdrawal by Subject                10                8 
Lost to Follow-up                3                2 
Lack of Efficacy                13                20 
Treatment failure criteria met                47                71 
Not specified                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.
Open-label Safety Population defined as all subjects who took at least 1 dose of any investigational product during the study. Two subjects did not receive investigational product, therefore n = 526.

Reporting Groups
  Description
Guanfacine Hydrochloride Administered as a once-daily oral dose between 1-7mg/day depending on age and weight

Baseline Measures
   Guanfacine Hydrochloride 
Overall Participants Analyzed 
[Units: Participants]
 		 526 
Age 
[Units: Years]
Mean (Standard Deviation) 		 10.7  (2.7) 
Age, Customized 
[Units: Participants]
 		 
6-12 years   391 
13-17 years   135 
Gender 
[Units: Participants]
 		 
Female   130 
Male   396 
Region of Enrollment 
[Units: Participants]
 		 
BELGIUM   19 
CANADA   30 
FRANCE   14 
GERMANY   27 
ITALY   31 
NETHERLANDS   29 
SPAIN   68 
SWEDEN   5 
UNITED KINGDOM   25 
UNITED STATES   278 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase   [ Time Frame: 26 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase   [ Time Frame: 26 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline and week 26 ]
  Show Outcome Measure 3

4.  Secondary:   Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF   [ Time Frame: 26 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF   [ Time Frame: Baseline and week 26 ]
  Show Outcome Measure 5

6.  Secondary:   Health Utilities Index-2/3 (HUI 2/3) Scores During the Double-Blind Randomized-Withdrawal Phase - LOCF   [ Time Frame: 26 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Columbia-Suicide Severity Rating Scale During Double-Blind Randomized-Withdrawal Phase   [ Time Frame: 26 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Change From Open-Label Baseline in ADHD-RS-IV Total Score at Week 13 of the Open-Label Phase - LOCF   [ Time Frame: Baseline and 13 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Responders in the Open-Label Phase - LOCF   [ Time Frame: 13 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores During Open-Label Phase - LOCF   [ Time Frame: 13 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on CGI-S Scale During the Open-Label Phase - LOCF   [ Time Frame: 13 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Change From Open-Label Baseline in WFIRS-P Global Score at Week 13 of the Open-Label Phase - LOCF   [ Time Frame: Baseline and week 13 ]
  Show Outcome Measure 12

13.  Secondary:   HUI 2/3 Scores During the Open-Label Phase - LOCF   [ Time Frame: 13 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Columbia-Suicide Severity Rating Scale During Open-Label Phase   [ Time Frame: 13 weeks ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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  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 Development LLC
phone: +1 866 842 5335


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01081145     History of Changes
Other Study ID Numbers: SPD503-315
2009-018161-12 ( EudraCT Number )
Study First Received: March 3, 2010
Results First Received: May 9, 2014
Last Updated: November 25, 2014