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Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00150618
First received: September 6, 2005
Last updated: November 25, 2009
Last verified: November 2009
Results First Received: September 10, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Attention Deficit Disorder With Hyperactivity
Interventions: Drug: SPD503 (1 mg)
Drug: SPD503 (2 mg)
Drug: SPD503 (3 mg)
Drug: SPD503 (4 mg)
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Although 324 subjects were randomized, 2 never received drug and therefore were not included in the Baseline Characteristics. Subjects received either 1, 2, 3, or 4 mg of SPD503 (Guanfacine hydrochloride) or placebo once daily.

Reporting Groups
  Description
SPD503 (1 mg) Guanfacine HCl once daily
SPD503 (2 mg) Guanfacine HCl once daily
SPD503 (3 mg) Guanfacine HCl once daily
SPD503 (4 mg) Guanfacine HCl once daily
Placebo once daily

Participant Flow:   Overall Study
    SPD503 (1 mg)     SPD503 (2 mg)     SPD503 (3 mg)     SPD503 (4 mg)     Placebo  
STARTED     62     65     65     66     66  
COMPLETED     45     47     38     40     41  
NOT COMPLETED     17     18     27     26     25  
Adverse Event                 2                 2                 6                 9                 5  
Withdrawal by Subject                 6                 8                 8                 4                 5  
Lost to Follow-up                 4                 1                 5                 8                 4  
Protocol Violation                 1                 0                 0                 0                 1  
Lack of Efficacy                 1                 4                 7                 4                 6  
No study meds                 0                 0                 0                 0                 2  
Physician Decision                 0                 2                 0                 0                 1  
Lack of compliance                 2                 1                 1                 0                 1  
Abnormal ECG                 1                 0                 0                 0                 0  
Sponsor's decision                 0                 0                 0                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
SPD503 (1 mg) Guanfacine HCl once daily
SPD503 (2 mg) Guanfacine HCl once daily
SPD503 (3 mg) Guanfacine HCl once daily
SPD503 (4 mg) Guanfacine HCl once daily
Placebo once daily
Total Total of all reporting groups

Baseline Measures
    SPD503 (1 mg)     SPD503 (2 mg)     SPD503 (3 mg)     SPD503 (4 mg)     Placebo     Total  
Number of Participants  
[units: participants]
  61     65     65     65     66     322  
Age  
[units: participants]
           
<=18 years     61     65     65     65     66     322  
Between 18 and 65 years     0     0     0     0     0     0  
>=65 years     0     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  9.3  ± 2.14     10.6  ± 2.81     11.1  ± 2.96     10.5  ± 2.53     10.8  ± 2.89     10.5  ± 2.74  
Gender  
[units: participants]
           
Female     20     19     17     12     21     89  
Male     41     46     48     53     45     233  
Region of Enrollment  
[units: participants]
           
United States     61     65     65     65     66     322  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks   [ Time Frame: Baseline and 6 weeks ]

2.  Secondary:   Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks   [ Time Frame: Baseline and 6 weeks ]

3.  Secondary:   Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)   [ Time Frame: 6 weeks ]

4.  Secondary:   Number of Participants With Improvement in Parent Global Assessment (PGA)   [ Time Frame: 6 weeks ]

5.  Secondary:   Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks   [ Time Frame: Baseline and 6 weeks ]


  Serious Adverse Events


  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
No text entered.


  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: Timothy Whitaker, MD
Organization: Shire Pharmaceuticals
e-mail: twhitaker@shire.com


Publications of Results:
Guanfacine Extended release in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Placebo-Controlled Trial. Sallee FR, McGough J, Wigal T, et al. J. Am. Acad. Child Adolesc. Psychiatry, 2009; 48(2):155-165.


ClinicalTrials.gov Identifier: NCT00150618     History of Changes
Other Study ID Numbers: SPD503-304
Study First Received: September 6, 2005
Results First Received: September 10, 2009
Last Updated: November 25, 2009
Health Authority: United States: Food and Drug Administration