Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01552915
• Collaborator: (none)
• Enrollment: 464
• Locations: 79
• Arms: 3
• Actual Duration (Months): 21.2
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Condition or Disease	Intervention/Treatment	Phase
Attention-deficit/Hyperactivity Disorder	Drug: Lisdexamfetamine dimesylate; Drug: Methylphenidate Hydrochloride; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 464 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Dose-optimization Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
• Actual Study Start Date: Apr 17, 2012
• Actual Primary Completion Date: Jan 22, 2014
• Actual Study Completion Date: Jan 22, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lisdexamfetamine Dimesylate	Drug: Lisdexamfetamine dimesylate; Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance; Other Names: LDX, Vyvanse, SPD489
Active Comparator: Methylphenidate Hydrochloride	Drug: Methylphenidate Hydrochloride; Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance; Other Names: OROS-MPH, Concerta
Placebo Comparator: Placebo	Drug: Placebo; Daily oral dosing in the AM for 8 weeks

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8 [Baseline and week 8]

   The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.

Secondary Outcome Measures

1. Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF) [Week 8]

   Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

2. Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment [Baseline and up to 8 Weeks]

3. Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment [Baseline and up to 8 weeks]

4. Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment [Baseline and up to 8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject must be 13-17 years of age, inclusive, at the time of consent.

• Subject must weigh more than 79.5lb.

• The parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration.

• Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.

• Subject has an ADHD-RS-IV total score ≥28.

• Subject is able to swallow a capsule.

• Subject does not have hypertension and has a resting sitting blood pressure less than or equal to 135/85mmHg.

Exclusion Criteria

• Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder.

• Diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.

• Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded.

• Subject is underweight or overweight.

• Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition. Mild, stable asthma is not exclusionary.

• Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.

• Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her at increased vulnerability to the sympathomimetic effects of a stimulant medication.

• Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

• Subject has any clinically significant ECG or clinically significant laboratory abnormality.

• Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.

• Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.

• Subject has a documented allergy, hypersensitivity, or intolerance to MPH or to any excipients in the reference product.

• Subject has failed to fully respond to an adequate course(s) (dose and duration) of MPH or amphetamine therapy.

• Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine). Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.

• Subject has a positive urine drug result.

• Subject has previously participated in this study or another clinical study involving SPD489/NRP104.

• Subject has glaucoma.

• Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.

• Subject is female and is pregnant or lactating.

• Subject is well controlled on his/her current ADHD medication.

• Subject has a pre-existing severe gastrointestinal tract narrowing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Melmed Center	Scottsdale	Arizona	United States	85254
2	Clinical Study Centers, LLC	Little Rock	Arkansas	United States	72211
3	Synergy Clinical Research Center	National City	California	United States	91950
4	Pacific Clinical Research Medical Group	Orange	California	United States	92868
5	SDS Clinical Trials, Inc.	Orange	California	United States	92868
6	Peninsula Research Associates, Inc.	Rolling Hills Estates	California	United States	90274
7	PCSD - Feighner Research	San Diego	California	United States	92108
8	University of California, San Francisco	San Francisco	California	United States	94143
9	Neuropsychiatric Research Center of Orange County	Santa Ana	California	United States	92701
10	Elite Clinical Trials	Wildomar	California	United States	92595
11	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado	United States	80910
12	Florida Clinical Research Center, LLC	Bradenton	Florida	United States	34201
13	Sarkis Clinical Trials	Gainesville	Florida	United States	32608
14	Amedica Research Institute	Hialeah	Florida	United States	33013
15	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida	United States	32256
16	Fidelity Clinical Research, Inc.	Lauderhill	Florida	United States	33319
17	Florida Clinical Research Center, LLC	Maitland	Florida	United States	32751
18	Scientific Clinical Research, Inc.	Miami	Florida	United States	33161
19	Clinical Neuroscience Solutions, Inc.	Orlando	Florida	United States	32806
20	Compass Research, LLC	Orlando	Florida	United States	32806
21	Stedman Clinical Trials	Tampa	Florida	United States	33613
22	Janus Center for Psychiatric Research	West Palm Beach	Florida	United States	33407
23	Atlanta Institute of Medicine and Research	Atlanta	Georgia	United States	30328
24	Capstone Clinical Research	Libertyville	Illinois	United States	60048
25	AMR Baber Research Group, Inc.	Naperville	Illinois	United States	60563
26	AMR Conventions Research	Naperville	Illinois	United States	60563
27	American Medical Research, Inc	Oak Brook	Illinois	United States	60523
28	Advocate Hope Children's Hospital	Oak Lawn	Illinois	United States	60453
29	Neuroscience Research Institute, Inc	Oak Park	Illinois	United States	60301
30	Psychiatric Associates	Overland Park	Kansas	United States	66211
31	University of Kentucky	Lexington	Kentucky	United States	40509
32	Four Rivers Clinical Research	Paducah	Kentucky	United States	42003
33	Neuroscientific InSights	Rockville	Maryland	United States	20852
34	Marc Hertzman MD, PC	Rockville	Maryland	United States	20882
35	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan	United States	48307
36	Clinical Neurophysiology Services, PC	Sterling Heights	Michigan	United States	48314
37	Behavioral Medical Center - Troy	Troy	Michigan	United States	48083
38	Precise Research Centers	Flowood	Mississippi	United States	39232
39	Comprehensive Psychiatric Associates	Gladstone	Missouri	United States	64118
40	St Charles Psychiatric Associates	Saint Charles	Missouri	United States	63301
41	Premier Psychiatric Research Institute	Lincoln	Nebraska	United States	68526
42	University of Nebraska Medical Center	Omaha	Nebraska	United States	68105
43	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada	United States	89128
44	Center for Emotional Fitness	Cherry Hill	New Jersey	United States	08002
45	CRCNJ - Clinical Research Center of New Jersey	Gibbsboro	New Jersey	United States	08026
46	Neurcognitive Institute	Mount Arlington	New Jersey	United States	07856
47	Mount Sinai School of Medicine	New York	New York	United States	10029
48	Duke Child and Family Study Center	Durham	North Carolina	United States	27705
49	Innovis Health, LLC	Fargo	North Dakota	United States	58103
50	North Coast Clinical Trials	Beachwood	Ohio	United States	44122
51	University of Cincinnati Dept. of Psychiatry & Behavioral	Cincinnati	Ohio	United States	45219
52	Cleveland Clinic	Cleveland	Ohio	United States	44195
53	The Ohio State University Nisonger Center	Columbus	Ohio	United States	43210
54	Midwest Clinical Research Center	Dayton	Ohio	United States	45417
55	Professional Psychiatric Services	Mason	Ohio	United States	45040
56	Family Practice of Wadsworth, Inc.	Wadsworth	Ohio	United States	44281
57	Cyn3rgy Research	Gresham	Oregon	United States	97030
58	Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)	Portland	Oregon	United States	97210
59	Summit Research Network (Oregon) Inc.	Portland	Oregon	United States	97210
60	Oregon Center for Clinical Investigations, Inc.	Salem	Oregon	United States	97301
61	Carolina Clinical Trials, Inc.	Charleston	South Carolina	United States	29407
62	Coastal Carolina Research Center	Mount Pleasant	South Carolina	United States	29464
63	Research Strategies of Memphis, LLC	Memphis	Tennessee	United States	38119
64	FutureSearch Trials	Austin	Texas	United States	78731
65	Claghorn-Lesem Reseach Clinic, Ltd.	Houston	Texas	United States	77008
66	Texas Center for Drug Development, Inc.	Houston	Texas	United States	77081
67	Red Oak Psychiatry Associates, PA	Houston	Texas	United States	77090
68	R/D Clinical Research, Inc.	Lake Jackson	Texas	United States	77586
69	Westex Clinical Investigations	Lubbock	Texas	United States	79423
70	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
71	University of Texas HSC at San Antonio Dept. of Psychiatry	San Antonio	Texas	United States	78229
72	Wharton Research Center, Inc.	Wharton	Texas	United States	77488
73	Psychiatric & Behavioral Solutions	Salt Lake City	Utah	United States	84105
74	University of Virginia Child and Family Psychiatry Clinical	Charlottesville	Virginia	United States	22903
75	NeuroScience, Inc.	Herndon	Virginia	United States	20170
76	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
77	Eastside Therapeutic Resource	Kirkland	Washington	United States	98033
78	Summit Research Network (Seattle), LLC	Seattle	Washington	United States	98104
79	Rockwood Clinic, P.S.	Spokane	Washington	United States	99202

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01552915
• Other Study ID Numbers: SPD489-405
• First Posted: Mar 13, 2012
• Last Update Posted: Jun 8, 2021
• Last Verified: May 1, 2021

• Keywords provided by Shire: ADHD
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Methylphenidate; Lisdexamfetamine Dimesylate

Study Results

Participant Flow

Arm/Group Title	Placebo	SPD489	OROS-MPH
Arm/Group Description	Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.	Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day	Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
Period Title: Overall Study
STARTED	91	184	184
COMPLETED	68	155	157
NOT COMPLETED	23	29	27

Baseline Characteristics

Arm/Group Title	Placebo	SPD489	OROS-MPH	Total
Arm/Group Description	Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.	Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.	Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.	Total of all reporting groups
Overall Participants	91	184	184	459
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	14.8 (1.43)	14.7 (1.38)	14.7 (1.32)	14.7 (1.37)
Age, Customized (Count of Participants)
<=18 years	91 100%	184 100%	184 100%	459 100%
Sex: Female, Male (Count of Participants)
Female	30 33%	62 33.7%	62 33.7%	154 33.6%
Male	61 67%	122 66.3%	122 66.3%	305 66.4%
Region of Enrollment (Count of Participants)
UNITED STATES	91 100%	184 100%	184 100%	459 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8
Description	The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.
Time Frame	Baseline and week 8

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.

Arm/Group Title	Placebo	SPD489	OROS-MPH
Arm/Group Description	Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.	Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.	Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
Measure Participants	89	179	184
Least Squares Mean (Standard Error) [units on a scale]	-13.4 (1.19)	-25.6 (0.82)	-23.5 (0.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SPD489, OROS-MPH
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0717
	Comments
	Method	mixed effects model for repeated measure
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-2.1
	Confidence Interval	(2-Sided) 95%; -4.3 to 0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.15
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, SPD489
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	mixed effects model for repeated measure
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-12.2
	Confidence Interval	(2-Sided) 95%; -15.1 to -9.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.45
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, OROS-MPH
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	mixed effects model for repeated measure
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Mean
	Estimated Value	-10.1
	Confidence Interval	(2-Sided) 95%; -13.0 to -7.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.43
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)
Description	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.

Arm/Group Title	Placebo	SPD489	OROS-MPH
Arm/Group Description	Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.	Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.	Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
Measure Participants	89	178	184
Number [percentage of participants]	34.8 38.2%	83.1 45.2%	81.0 44%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SPD489, OROS-MPH
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6165
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, SPD489
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, OROS-MPH
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

3. Secondary Outcome

Title	Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Time Frame	Baseline and up to 8 Weeks

Outcome Measure Data

Analysis Population Description

Safety Set: All randomized subjects who took at least 1 dose of investigational product.

Arm/Group Title	Placebo	SPD489	OROS-MPH
Arm/Group Description	Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.	Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.	Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
Measure Participants	89	179	184
Mean (Standard Deviation) [mmHg]	-0.8 (8.97)	2.4 (9.46)	0.4 (9.90)

4. Secondary Outcome

Title	Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Time Frame	Baseline and up to 8 weeks

Outcome Measure Data

Analysis Population Description

Safety Set: All randomized subjects who took at least 1 dose of investigational product.

Arm/Group Title	Placebo	SPD489	OROS-MPH
Arm/Group Description	Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.	Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.	Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
Measure Participants	89	179	184
Mean (Standard Deviation) [mmHg]	-1.2 (8.11)	2.8 (8.41)	2.2 (8.64)

5. Secondary Outcome

Title	Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment
Time Frame	Baseline and up to 8 weeks

Outcome Measure Data

Analysis Population Description

Safety Set: All randomized subjects who took at least 1 dose of investigational product.

Arm/Group Title	Placebo	SPD489	OROS-MPH
Arm/Group Description	Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.	Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.	Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
Measure Participants	89	179	184
Mean (Standard Deviation) [bpm]	0.3 (11.32)	4.7 (11.82)	6.0 (10.52)

Adverse Events

Time Frame	Duration of the study, for up to 8 weeks per participant
Adverse Event Reporting Description	Treatment-Emergent Adverse Events
Arm/Group Title	Placebo		SPD489		OROS-MPH
Arm/Group Description	Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.		Subjects received over encapsulated SPD489 optimized among a 30, 50, or 70mg dose.		Subjects received over encapsulated OROS-MPH optimized among a 18, 36, 54 or 72mg dose. Subjects optimized to 72mg received two 36mg tablets.
All Cause Mortality
	Placebo		SPD489		OROS-MPH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		SPD489		OROS-MPH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/91 (0%)		1/184 (0.5%)		1/184 (0.5%)
Psychiatric disorders
Suicidal ideation	0/91 (0%)	0	1/184 (0.5%)	1	0/184 (0%)	0
Renal and urinary disorders
Renal cyst	0/91 (0%)	0	0/184 (0%)	0	1/184 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Placebo		SPD489		OROS-MPH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	39/91 (42.9%)		139/184 (75.5%)		120/184 (65.2%)
Gastrointestinal disorders
Abdominal pain upper	4/91 (4.4%)	6	12/184 (6.5%)	12	10/184 (5.4%)	13
Dry mouth	1/91 (1.1%)	1	15/184 (8.2%)	17	11/184 (6%)	11
Nausea	4/91 (4.4%)	4	14/184 (7.6%)	14	15/184 (8.2%)	17
General disorders
Fatigue	3/91 (3.3%)	3	10/184 (5.4%)	10	5/184 (2.7%)	5
Irritability	9/91 (9.9%)	9	37/184 (20.1%)	41	14/184 (7.6%)	17
Infections and infestations
Nasopharyngitis	1/91 (1.1%)	1	11/184 (6%)	12	13/184 (7.1%)	13
Upper respiratory tract infection	8/91 (8.8%)	9	9/184 (4.9%)	9	6/184 (3.3%)	6
Investigations
Heart rate increased	0/91 (0%)	0	8/184 (4.3%)	8	11/184 (6%)	12
Weight decreased	1/91 (1.1%)	1	37/184 (20.1%)	43	24/184 (13%)	26
Metabolism and nutrition disorders
Decreased appetite	7/91 (7.7%)	8	98/184 (53.3%)	118	77/184 (41.8%)	85
Nervous system disorders
Dizziness	1/91 (1.1%)	1	12/184 (6.5%)	13	8/184 (4.3%)	9
Headache	7/91 (7.7%)	8	28/184 (15.2%)	38	28/184 (15.2%)	35
Somnolence	4/91 (4.4%)	5	10/184 (5.4%)	10	6/184 (3.3%)	6
Psychiatric disorders
Initial insomnia	2/91 (2.2%)	2	15/184 (8.2%)	17	12/184 (6.5%)	16
Insomnia	0/91 (0%)	0	16/184 (8.7%)	17	15/184 (8.2%)	15

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.