Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Dose titration of SPD503 (Guanfacine HCl) for 3 weeks starting at 1 mg/day and increased in 1 mg weekly increments up to 4 mg/day (or to the highest tolerated dose); then dose maintenance for 3 weeks; then downward titration of SPD503 at 1 mg weekly decrements for 3 weeks while maintaining the subject's current psychostimulant dose and frequency.

Reporting Groups

	Description
Methylphenidate + SPD503	Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
Amphetamine + SPD503	Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.

Participant Flow:   Overall Study

	Methylphenidate + SPD503	Amphetamine + SPD503
STARTED	42	33
COMPLETED	37	26
NOT COMPLETED	5	7
Adverse Event	3	2
Withdrawal by Subject	1	1
Protocol Violation	1	2
Sponsor's decision	0	2

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.
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Reporting Groups

	Description
Methylphenidate + SPD503	Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
Amphetamine + SPD503	Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
Total	Total of all reporting groups

Baseline Measures

	Methylphenidate + SPD503	Amphetamine + SPD503	Total
Overall Participants Analyzed  [Units: Participants]	42	33	75
Age  [Units: Participants]
<=18 years	42	33	75
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age  [Units: Years] Mean (Standard Deviation)	11.1  (1.79)	11.6  (2.62)	11.4  (2.19)
Gender  [Units: Participants]
Female	13	7	20
Male	29	26	55
Region of Enrollment  [Units: Participants]
United States	42	33	75

1.  Primary:

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

2.  Secondary:

Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores   [ Time Frame: 6 weeks ]

3.  Secondary:

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

4.  Secondary:

Number of Participants With Improvement on Parent Global Assessment (PGA) Scores   [ Time Frame: 6 weeks ]

5.  Secondary:

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

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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