Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17

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
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Reporting Groups

	Description
Lisdexamfetamine Dimesylate (LDX)	Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Methylphenidate Hydrochloride	Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
Placebo	Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.

Participant Flow:   Overall Study

	Lisdexamfetamine Dimesylate (LDX)	Methylphenidate Hydrochloride	Placebo
STARTED	113	112	111
COMPLETED	80	74	42
NOT COMPLETED	33	38	69
Adverse Event	5	2	4
Protocol Violation	3	3	2
Withdrawal by Subject	4	5	5
Lost to Follow-up	0	1	0
Lack of Efficacy	11	22	54
Unable to swallow capsule	2	1	1
Personal reason	3	0	0
Exclusion criteria met	1	0	0
Sponsor decision	1	0	0
Due to holiday season	2	0	1
Randomization error	0	0	1
Medical monitor decision	0	0	1
Moved to another country	0	1	0
Subject wanted dose reduction	0	1	0
Lack of availability	0	1	0
Performed final visit on phone	0	1	0
Participation in 489-326 required	1	0	0

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
Lisdexamfetamine Dimesylate (LDX)	Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Methylphenidate Hydrochloride	Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
Placebo	Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
Total	Total of all reporting groups

Baseline Measures

	Lisdexamfetamine Dimesylate (LDX)	Methylphenidate Hydrochloride	Placebo	Total
Overall Participants Analyzed  [Units: Participants]	111	111	110	332
Age [1]  [Units: Years] Mean (Standard Deviation)	10.9  (2.87)	10.9  (2.63)	11.0  (2.82)	10.9  (2.77)
[1] Safety Population was used for demographics. Safety Population defined as all subjects who took at least 1 dose of investigational product. Four randomized subjects (2 in the LDX group, 1 in the Methylphenidate group, and 1 in the placebo group) did not receive investigational product and were therefore excluded from the Safety Population (n = 332).
Age, Customized [1]  [Units: Participants]
6-12 years	77	80	79	236
13-17 years	34	31	31	96
[1] Safety Population was used for demographics. Safety Population defined as all subjects who took at least 1 dose of investigational product. Four randomized subjects (2 in the LDX group, 1 in the Methylphenidate group, and 1 in the placebo group) did not receive investigational product and were therefore excluded from the Safety Population (n = 332).
Gender [1]  [Units: Participants]
Female	24	21	19	64
Male	87	90	91	268
[1] Safety Population was used for demographics. Safety Population defined as all subjects who took at least 1 dose of investigational product. Four randomized subjects (2 in the LDX group, 1 in the Methylphenidate group, and 1 in the placebo group) did not receive investigational product and were therefore excluded from the Safety Population( n = 332).
Region of Enrollment [1]  [Units: Participants]
France	10	9	11	30
Hungary	11	10	11	32
Spain	13	14	14	41
Poland	3	4	3	10
Belgium	4	3	4	11
Netherlands	1	0	0	1
Germany	36	36	35	107
United Kingdom	8	10	9	27
Italy	9	9	7	25
Sweden	18	17	17	52
[1] This includes All Enrolled Subjects. Enrolled Population defined as all subjects who were randomized (n = 336).

1.  Primary:

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks   [ Time Frame: Baseline and up to 7 weeks ]

2.  Secondary:

Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores   [ Time Frame: Up to 7 weeks ]

3.  Secondary:

Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks   [ Time Frame: Baseline and up to 7 weeks ]

4.  Secondary:

Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks   [ Time Frame: Baseline and up to 7 weeks ]

5.  Secondary:

Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks   [ Time Frame: Baseline and up to 7 weeks ]

6.  Secondary:

Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks   [ Time Frame: Baseline and up to 7 weeks ]

7.  Secondary:

Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks   [ Time Frame: Baseline and up to 7 weeks ]

8.  Secondary:

Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Up to 7 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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