Trial Outcomes & Findings for Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia (NCT NCT01457339)

NCT ID: NCT01457339

Last Updated: 2021-06-03

Results Overview

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 31 participants
• Primary outcome timeframe: Baseline and day 5
• Results posted on: 2021-06-03

Participant Flow

Participant milestones

Measure	Placebo Placebo Capsule(s) for oral use taken once daily for 30 days	SPD489 (Lisdexamfetamine Dimesylate) Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
Period 1 (50 mg) STARTED	7	24
Period 1 (50 mg) COMPLETED	7	24
Period 1 (50 mg) NOT COMPLETED	0	0
Period 2 (70 mg) STARTED	7	24
Period 2 (70 mg) COMPLETED	7	24
Period 2 (70 mg) NOT COMPLETED	0	0
Period 3 (100 mg) STARTED	7	24
Period 3 (100 mg) COMPLETED	7	23
Period 3 (100 mg) NOT COMPLETED	0	1
Period 4 (150 mg) STARTED	7	23
Period 4 (150 mg) COMPLETED	7	23
Period 4 (150 mg) NOT COMPLETED	0	0
Period 5 (200 mg) STARTED	7	23
Period 5 (200 mg) COMPLETED	7	22
Period 5 (200 mg) NOT COMPLETED	0	1
Period 6 (250 mg) STARTED	7	22
Period 6 (250 mg) COMPLETED	6	21
Period 6 (250 mg) NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Placebo Placebo Capsule(s) for oral use taken once daily for 30 days	SPD489 (Lisdexamfetamine Dimesylate) Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
Period 3 (100 mg) Adverse Event	0	1
Period 5 (200 mg) Met stopping criteria for PANSS score	0	1
Period 6 (250 mg) Family Emergency	1	0
Period 6 (250 mg) Personal appointment	0	1

Baseline Characteristics

Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia

Baseline characteristics by cohort

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 30 days	SPD489 (Lisdexamfetamine Dimesylate)(All Doses) n=24 Participants Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants	24 Participants n=4 Participants	31 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	49.6 years STANDARD_DEVIATION 4.93 • n=93 Participants	46.4 years STANDARD_DEVIATION 7.86 • n=4 Participants	47.1 years STANDARD_DEVIATION 7.35 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	19 Participants n=4 Participants	25 Participants n=27 Participants
Region of Enrollment United States	7 Participants n=93 Participants	24 Participants n=4 Participants	31 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg	-0.14 mmHg Standard Deviation 9.543	8.94 mmHg Standard Deviation 11.510

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg	1.43 mmHg Standard Deviation 12.593	3.82 mmHg Standard Deviation 9.258

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg	0.43 mmHg Standard Deviation 6.448	4.96 mmHg Standard Deviation 9.208

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg	-2.81 mmHg Standard Deviation 7.358	6.43 mmHg Standard Deviation 13.519

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg	-2.38 mmHg Standard Deviation 11.546	5.28 mmHg Standard Deviation 11.761

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg	-0.28 mmHg Standard Deviation 13.442	7.36 mmHg Standard Deviation 15.569

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg	2.86 mmHg Standard Deviation 11.547	5.22 mmHg Standard Deviation 8.364

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg	2.38 mmHg Standard Deviation 10.557	2.14 mmHg Standard Deviation 6.468

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg	2.14 mmHg Standard Deviation 7.796	4.55 mmHg Standard Deviation 7.641

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg	2.67 mmHg Standard Deviation 10.846	2.43 mmHg Standard Deviation 10.672

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg	2.76 mmHg Standard Deviation 14.442	3.77 mmHg Standard Deviation 8.041

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg	3.67 mmHg Standard Deviation 8.618	3.79 mmHg Standard Deviation 10.106

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Pulse Rate at Day 5: 50 mg	2.62 beats/min Standard Deviation 9.534	3.78 beats/min Standard Deviation 11.116

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Pulse Rate at Day 5: 70 mg	-0.95 beats/min Standard Deviation 9.821	5.07 beats/min Standard Deviation 9.500

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Pulse Rate at Day 5: 100 mg	0.19 beats/min Standard Deviation 10.306	5.72 beats/min Standard Deviation 12.578

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Pulse Rate at Day 5: 150 mg	-1.05 beats/min Standard Deviation 8.125	6.41 beats/min Standard Deviation 13.782

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Pulse Rate at Day 5: 200 mg	2.38 beats/min Standard Deviation 10.058	8.88 beats/min Standard Deviation 12.206

PRIMARY outcome

Timeframe: Baseline and day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Pulse Rate at Day 5: 250 mg	2.06 beats/min Standard Deviation 9.760	12.39 beats/min Standard Deviation 12.666

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Outcome measures

Measure	Placebo n=24 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg	25.6 ng*hr/ml Standard Deviation 12.9	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Outcome measures

Measure	Placebo n=24 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg	43.7 ng*hr/ml Standard Deviation 27.5	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Outcome measures

Measure	Placebo n=23 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg	80.5 ng*hr/ml Standard Deviation 37.2	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Outcome measures

Measure	Placebo n=22 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg	144.9 ng*hr/ml Standard Deviation 43.7	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Outcome measures

Measure	Placebo n=21 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg	230.2 ng*hr/ml Standard Deviation 81.1	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Outcome measures

Measure	Placebo n=21 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg	301.5 ng*hr/ml Standard Deviation 105.9	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

Outcome measures

Measure	Placebo n=24 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg	21.93 ng/ml Standard Deviation 9.96	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

Outcome measures

Measure	Placebo n=24 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg	35.02 ng/ml Standard Deviation 21.35	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

Outcome measures

Measure	Placebo n=23 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg	50.6 ng/ml Standard Deviation 18.9	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

Outcome measures

Measure	Placebo n=22 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg	90.34 ng/ml Standard Deviation 30.45	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

Outcome measures

Measure	Placebo n=21 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg	133.3 ng/ml Standard Deviation 63.17	—

SECONDARY outcome

Timeframe: Day 5 (12-hour sampling period post-dose)

Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

Outcome measures

Measure	Placebo n=21 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) Oral 50 mg dose of SPD489 administered once daily for 5 days.
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg	181.53 ng/ml Standard Deviation 72.82	—

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg	0.6 units on a scale Standard Error 2.22	-1.9 units on a scale Standard Error 1.10

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg	-2.1 units on a scale Standard Error 1.81	-2.9 units on a scale Standard Error 1.50

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg	-3.6 units on a scale Standard Error 1.43	-3.9 units on a scale Standard Error 1.68

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg	-2.1 units on a scale Standard Error 1.40	-4.7 units on a scale Standard Error 1.44

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg	-2.3 units on a scale Standard Error 2.01	-4.6 units on a scale Standard Error 1.81

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg	-2.3 units on a scale Standard Error 2.03	-2.4 units on a scale Standard Error 2.01

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg	-1.4 units on a scale Standard Error 1.54	-1.7 units on a scale Standard Error 1.09

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg	-3.0 units on a scale Standard Error 2.85	-3.1 units on a scale Standard Error 1.15

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg	-7.0 units on a scale Standard Error 3.07	-2.6 units on a scale Standard Error 1.27

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg	-4.0 units on a scale Standard Error 3.24	-3.0 units on a scale Standard Error 1.17

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg	1.3 units on a scale Standard Error 3.75	-2.6 units on a scale Standard Error 1.11

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg	-4.2 units on a scale Standard Error 2.15	-3.3 units on a scale Standard Error 1.47

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg	0.0 units on a scale Standard Error 0.38	-0.3 units on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg	-0.4 units on a scale Standard Error 0.30	-0.7 units on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg	-0.4 units on a scale Standard Error 0.30	-0.9 units on a scale Standard Error 0.34

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg	-0.7 units on a scale Standard Error 0.47	-1.0 units on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg	-0.4 units on a scale Standard Error 0.30	-0.6 units on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg	-0.2 units on a scale Standard Error 0.40	-0.3 units on a scale Standard Error 0.48

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg	-0.4 units on a scale Standard Error 0.30	0.0 units on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg	-0.6 units on a scale Standard Error 0.43	-0.1 units on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg	-0.4 units on a scale Standard Error 0.48	0.0 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg	-0.3 units on a scale Standard Error 0.29	0.1 units on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg	0.0 units on a scale Standard Error 0.52	0.0 units on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg	0.2 units on a scale Standard Error 0.31	0.0 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg	0.0 units on a scale Standard Error 0.00	0.0 units on a scale Standard Error 0.00

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg	0.0 units on a scale Standard Error 0.00	0.0 units on a scale Standard Error 0.00

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg	0.0 units on a scale Standard Error 0.00	0.0 units on a scale Standard Error 0.00

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg	0.0 units on a scale Standard Error 0.00	0.0 units on a scale Standard Error 0.00

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg	0.0 units on a scale Standard Error 0.00	0.2 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg	0.0 units on a scale Standard Error 0.00	0.0 units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg	-0.9 Number of Errors Standard Error 8.02	-8.2 Number of Errors Standard Error 5.79

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg	8.7 Number of Errors Standard Error 10.77	-7.3 Number of Errors Standard Error 6.45

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg	0.9 Number of Errors Standard Error 9.55	-15.7 Number of Errors Standard Error 6.57

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg	21.1 Number of Errors Standard Error 28.75	-11.3 Number of Errors Standard Error 6.26

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg	-10.3 Number of Errors Standard Error 6.30	-16.5 Number of Errors Standard Error 6.65

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg	-5.0 Number of Errors Standard Error 8.74	-13.2 Number of Errors Standard Error 5.25

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg	0.0 Log10 milliseconds Standard Error 0.0389	-0.034 Log10 milliseconds Standard Error 0.0223

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg	0.017 Log10 milliseconds Standard Error 0.0411	-0.015 Log10 milliseconds Standard Error 0.0195

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg	0.014 Log10 milliseconds Standard Error 0.0492	-0.047 Log10 milliseconds Standard Error 0.0246

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg	0.037 Log10 milliseconds Standard Error 0.0373	-0.039 Log10 milliseconds Standard Error 0.0180

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg	-0.025 Log10 milliseconds Standard Error 0.0395	-0.049 Log10 milliseconds Standard Error 0.0178

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg	-0.034 Log10 milliseconds Standard Error 0.0581	-0.048 Log10 milliseconds Standard Error 0.0147

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg	0.028 Log10 milliseconds Standard Error 0.0304	0.001 Log10 milliseconds Standard Error 0.0141

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg	0.015 Log10 milliseconds Standard Error 0.0273	0.006 Log10 milliseconds Standard Error 0.0113

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg	0.011 Log10 milliseconds Standard Error 0.0348	0.001 Log10 milliseconds Standard Error 0.0171

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg	0.036 Log10 milliseconds Standard Error 0.0419	-0.010 Log10 milliseconds Standard Error 0.0172

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg	0.044 Log10 milliseconds Standard Error 0.0397	-0.014 Log10 milliseconds Standard Error 0.0157

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg	0.005 Log10 milliseconds Standard Error 0.0531	-0.007 Log10 milliseconds Standard Error 0.0144

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg	0.025 Arcsine proportion correct Standard Error 0.0234	0.005 Arcsine proportion correct Standard Error 0.0179

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg	0.015 Arcsine proportion correct Standard Error 0.0322	0.021 Arcsine proportion correct Standard Error 0.0189

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg	0.012 Arcsine proportion correct Standard Error 0.0373	0.012 Arcsine proportion correct Standard Error 0.0197

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=23 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg	0.026 Arcsine proportion correct Standard Error 0.0415	0.042 Arcsine proportion correct Standard Error 0.0222

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=7 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg	-0.020 Arcsine proportion correct Standard Error 0.0394	0.046 Arcsine proportion correct Standard Error 0.0219

SECONDARY outcome

Timeframe: Baseline and Day 5

Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).

Outcome measures

Measure	Placebo n=6 Participants Placebo Capsule(s) for oral use taken once daily for 5 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=22 Participants Oral 50 mg dose of SPD489 administered once daily for 5 days.
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg	0.018 Arcsine proportion correct Standard Error 0.0432	0.022 Arcsine proportion correct Standard Error 0.0250

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

SPD489 (Lisdexamfetamine Dimesylate)(50 mg)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

SPD489 (Lisdexamfetamine Dimesylate)(70 mg)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

SPD489 (Lisdexamfetamine Dimesylate)(100 mg)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

SPD489 (Lisdexamfetamine Dimesylate)(150 mg)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

SPD489 (Lisdexamfetamine Dimesylate)(200 mg)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

SPD489 (Lisdexamfetamine Dimesylate)(250 mg)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

SPD489 (Lisdexamfetamine Dimesylate)(All Doses)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=7 participants at risk Placebo Capsule(s) for oral use taken once daily for 30 days	SPD489 (Lisdexamfetamine Dimesylate)(50 mg) n=24 participants at risk Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).	SPD489 (Lisdexamfetamine Dimesylate)(70 mg) n=24 participants at risk Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).	SPD489 (Lisdexamfetamine Dimesylate)(100 mg) n=24 participants at risk Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).	SPD489 (Lisdexamfetamine Dimesylate)(150 mg) n=23 participants at risk Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).	SPD489 (Lisdexamfetamine Dimesylate)(200 mg) n=23 participants at risk Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).	SPD489 (Lisdexamfetamine Dimesylate)(250 mg) n=22 participants at risk Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).	SPD489 (Lisdexamfetamine Dimesylate)(All Doses) n=24 participants at risk Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/7	16.7% 4/24 • Number of events 4	0.00% 0/24	0.00% 0/24	0.00% 0/23	0.00% 0/23	0.00% 0/22	16.7% 4/24 • Number of events 4
Psychiatric disorders Insomnia	0.00% 0/7	12.5% 3/24 • Number of events 3	4.2% 1/24 • Number of events 1	4.2% 1/24 • Number of events 1	8.7% 2/23 • Number of events 2	0.00% 0/23	4.5% 1/22 • Number of events 1	20.8% 5/24 • Number of events 8
Nervous system disorders Headache	14.3% 1/7 • Number of events 1	4.2% 1/24 • Number of events 1	0.00% 0/24	4.2% 1/24 • Number of events 1	17.4% 4/23 • Number of events 5	4.3% 1/23 • Number of events 1	18.2% 4/22 • Number of events 5	16.7% 4/24 • Number of events 13
Nervous system disorders Tremor	14.3% 1/7 • Number of events 1	4.2% 1/24 • Number of events 1	4.2% 1/24 • Number of events 1	4.2% 1/24 • Number of events 1	8.7% 2/23 • Number of events 2	4.3% 1/23 • Number of events 1	4.5% 1/22 • Number of events 1	20.8% 5/24 • Number of events 7
Psychiatric disorders Anxiety	0.00% 0/7	8.3% 2/24 • Number of events 2	4.2% 1/24 • Number of events 1	0.00% 0/24	0.00% 0/23	0.00% 0/23	9.1% 2/22 • Number of events 2	16.7% 4/24 • Number of events 5
Cardiac disorders Tachycardia	28.6% 2/7 • Number of events 2	12.5% 3/24 • Number of events 3	4.2% 1/24 • Number of events 1	4.2% 1/24 • Number of events 1	8.7% 2/23 • Number of events 2	0.00% 0/23	4.5% 1/22 • Number of events 1	25.0% 6/24 • Number of events 8
Eye disorders Vision blurred	0.00% 0/7	0.00% 0/24	0.00% 0/24	0.00% 0/24	0.00% 0/23	4.3% 1/23 • Number of events 1	4.5% 1/22 • Number of events 1	8.3% 2/24 • Number of events 2
Gastrointestinal disorders Constipation	0.00% 0/7	0.00% 0/24	8.3% 2/24 • Number of events 2	0.00% 0/24	0.00% 0/23	13.0% 3/23 • Number of events 3	0.00% 0/22	20.8% 5/24 • Number of events 5
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1	0.00% 0/24	0.00% 0/24	0.00% 0/24	13.0% 3/23 • Number of events 3	8.7% 2/23 • Number of events 2	9.1% 2/22 • Number of events 2	16.7% 4/24 • Number of events 7
Infections and infestations Folliculitis	0.00% 0/7	0.00% 0/24	0.00% 0/24	0.00% 0/24	0.00% 0/23	0.00% 0/23	9.1% 2/22 • Number of events 2	8.3% 2/24 • Number of events 2
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/7	0.00% 0/24	0.00% 0/24	8.3% 2/24 • Number of events 2	0.00% 0/23	0.00% 0/23	0.00% 0/22	8.3% 2/24 • Number of events 2
Gastrointestinal disorders Diarrhea	0.00% 0/7	4.2% 1/24 • Number of events 1	0.00% 0/24	4.2% 1/24 • Number of events 1	0.00% 0/23	0.00% 0/23	0.00% 0/22	8.3% 2/24 • Number of events 2
Gastrointestinal disorders Dry Mouth	0.00% 0/7	4.2% 1/24 • Number of events 1	4.2% 1/24 • Number of events 1	4.2% 1/24 • Number of events 1	0.00% 0/23	4.3% 1/23 • Number of events 1	0.00% 0/22	12.5% 3/24 • Number of events 4
Gastrointestinal disorders Dyspepsia	0.00% 0/7	0.00% 0/24	0.00% 0/24	4.2% 1/24 • Number of events 1	0.00% 0/23	0.00% 0/23	4.5% 1/22 • Number of events 1	8.3% 2/24 • Number of events 2
Investigations Blood Pressure Increased	0.00% 0/7	4.2% 1/24 • Number of events 1	0.00% 0/24	0.00% 0/24	0.00% 0/23	0.00% 0/23	4.5% 1/22 • Number of events 1	8.3% 2/24 • Number of events 2
Metabolism and nutrition disorders Increased Appetite	14.3% 1/7 • Number of events 1	4.2% 1/24 • Number of events 1	0.00% 0/24	0.00% 0/24	0.00% 0/23	0.00% 0/23	4.5% 1/22 • Number of events 1	8.3% 2/24 • Number of events 2
Nervous system disorders Akathisia	0.00% 0/7	0.00% 0/24	0.00% 0/24	0.00% 0/24	4.3% 1/23 • Number of events 1	4.3% 1/23 • Number of events 1	0.00% 0/22	8.3% 2/24 • Number of events 2
Psychiatric disorders Psychotic Disorder	0.00% 0/7	0.00% 0/24	0.00% 0/24	0.00% 0/24	4.3% 1/23 • Number of events 1	4.3% 1/23 • Number of events 1	0.00% 0/22	8.3% 2/24 • Number of events 2
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1	0.00% 0/24	0.00% 0/24	0.00% 0/24	0.00% 0/23	0.00% 0/23	4.5% 1/22 • Number of events 1	4.2% 1/24 • Number of events 1
Musculoskeletal and connective tissue disorders Muscle Spasms	14.3% 1/7 • Number of events 1	4.2% 1/24 • Number of events 1	0.00% 0/24	0.00% 0/24	0.00% 0/23	0.00% 0/23	0.00% 0/22	4.2% 1/24 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	14.3% 1/7 • Number of events 2	0.00% 0/24	0.00% 0/24	0.00% 0/24	0.00% 0/23	0.00% 0/23	0.00% 0/22	0.00% 0/24
Nervous system disorders Syncope Vasovagal	14.3% 1/7 • Number of events 1	0.00% 0/24	0.00% 0/24	0.00% 0/24	0.00% 0/23	0.00% 0/23	0.00% 0/22	0.00% 0/24

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: ClinicalTransparency@shire.com

Results disclosure agreements

• Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
• Publication restrictions are in place

Restriction type: OTHER