Trial Outcomes & Findings for Efficacy and Safety of SPD503 in Combination With Psychostimulants (NCT NCT00734578)
NCT ID: NCT00734578
Last Updated: 2021-06-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
461 participants
Primary outcome timeframe
Baseline and weekly up to 8 weeks
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
SPD503-AM + Psychostimulant
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Overall Study
STARTED
|
154
|
153
|
154
|
|
Overall Study
COMPLETED
|
121
|
128
|
129
|
|
Overall Study
NOT COMPLETED
|
33
|
25
|
25
|
Reasons for withdrawal
| Measure |
SPD503-AM + Psychostimulant
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
1
|
|
Overall Study
Protocol Violation
|
8
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
11
|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
5
|
|
Overall Study
Randomized in error
|
1
|
0
|
0
|
|
Overall Study
Exclusion criteria
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of SPD503 in Combination With Psychostimulants
Baseline characteristics by cohort
| Measure |
SPD503-AM + Psychostimulant
n=150 Participants
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=152 Participants
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=153 Participants
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.0 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
10.6 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
10.8 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 2.4 • n=4 Participants
|
|
Age, Customized
6-17 years
|
150 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
455 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
326 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
150 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
455 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and weekly up to 8 weeksPopulation: Full Analysis Set (FAS) which includes all subjects who received at least 1 dose of any study drug during this study.
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.
Outcome measures
| Measure |
SPD503-AM + Psychostimulant
n=149 Participants
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=148 Participants
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=152 Participants
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
|
-20.4 Units on a scale
Standard Deviation 12.77
|
-21.0 Units on a scale
Standard Deviation 12.39
|
-16.0 Units on a scale
Standard Deviation 11.77
|
SECONDARY outcome
Timeframe: Baseline and weekly up to 8 weeksPopulation: FAS
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.
Outcome measures
| Measure |
SPD503-AM + Psychostimulant
n=149 Participants
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=148 Participants
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=152 Participants
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF
|
70.5 Percent of participants
|
74.3 Percent of participants
|
57.9 Percent of participants
|
SECONDARY outcome
Timeframe: Baseline and weekly up to 8 weeksPopulation: FAS
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Outcome measures
| Measure |
SPD503-AM + Psychostimulant
n=149 Participants
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=148 Participants
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=152 Participants
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Normal, not at all ill
|
22.8 Percent of participants
|
25.0 Percent of participants
|
15.1 Percent of participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Borderline mentally ill
|
19.5 Percent of participants
|
26.4 Percent of participants
|
17.8 Percent of participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Mildly ill
|
34.2 Percent of participants
|
26.4 Percent of participants
|
28.9 Percent of participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Moderately ill
|
16.1 Percent of participants
|
16.2 Percent of participants
|
27.0 Percent of participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Markedly ill
|
6.0 Percent of participants
|
5.4 Percent of participants
|
9.2 Percent of participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Severely ill
|
1.3 Percent of participants
|
0.7 Percent of participants
|
2.0 Percent of participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Most extremely ill
|
0.0 Percent of participants
|
0.0 Percent of participants
|
0.0 Percent of participants
|
SECONDARY outcome
Timeframe: Baseline and weekly up to 8 weeksPopulation: FAS
The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30.
Outcome measures
| Measure |
SPD503-AM + Psychostimulant
n=149 Participants
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=147 Participants
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=153 Participants
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)
|
-8.4 Units on a scale
Standard Deviation 7.27
|
-9.6 Units on a scale
Standard Deviation 7.68
|
-6.9 Units on a scale
Standard Deviation 6.89
|
SECONDARY outcome
Timeframe: Baseline and weekly up to 8 weeksPopulation: FAS
The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30.
Outcome measures
| Measure |
SPD503-AM + Psychostimulant
n=149 Participants
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=147 Participants
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=153 Participants
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)
|
-8.2 Units on a scale
Standard Deviation 7.79
|
-8.8 Units on a scale
Standard Deviation 7.21
|
-6.0 Units on a scale
Standard Deviation 6.84
|
SECONDARY outcome
Timeframe: Baseline and week 8Population: FAS
Parent Global Assessment (PGA) 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.
Outcome measures
| Measure |
SPD503-AM + Psychostimulant
n=129 Participants
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=133 Participants
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=141 Participants
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF
|
69.8 Percent of participants
|
67.7 Percent of participants
|
47.5 Percent of participants
|
SECONDARY outcome
Timeframe: Baseline and weekly up to 8 weeksPopulation: FAS
The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.
Outcome measures
| Measure |
SPD503-AM + Psychostimulant
n=129 Participants
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=134 Participants
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=141 Participants
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF
|
-6.6 Units on a scale
Standard Deviation 6.97
|
-6.3 Units on a scale
Standard Deviation 7.05
|
-4.2 Units on a scale
Standard Deviation 6.79
|
SECONDARY outcome
Timeframe: Baseline and weekly up to 8 weeksPopulation: FAS
This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better.
Outcome measures
| Measure |
SPD503-AM + Psychostimulant
n=141 Participants
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=141 Participants
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=144 Participants
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF
|
-16.7 Units on a scale
Standard Deviation 13.87
|
-16.7 Units on a scale
Standard Deviation 13.45
|
-11.5 Units on a scale
Standard Deviation 13.45
|
SECONDARY outcome
Timeframe: Baseline and weekly up to 8 weeksPopulation: FAS
Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.
Outcome measures
| Measure |
SPD503-AM + Psychostimulant
n=149 Participants
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=148 Participants
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=153 Participants
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Very poor
|
0.7 Percent of participants
|
0.7 Percent of participants
|
0.0 Percent of participants
|
|
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Poor
|
6.7 Percent of participants
|
6.8 Percent of participants
|
3.3 Percent of participants
|
|
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Average
|
26.8 Percent of participants
|
29.7 Percent of participants
|
33.3 Percent of participants
|
|
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Very good
|
25.5 Percent of participants
|
21.6 Percent of participants
|
22.9 Percent of participants
|
|
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Good
|
40.3 Percent of participants
|
41.2 Percent of participants
|
40.5 Percent of participants
|
Adverse Events
SPD503-AM + Psychostimulant
Serious events: 1 serious events
Other events: 116 other events
Deaths: 0 deaths
SPD503-PM + Psychostimulant
Serious events: 2 serious events
Other events: 116 other events
Deaths: 0 deaths
Placebo + Psychostimulant
Serious events: 0 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPD503-AM + Psychostimulant
n=150 participants at risk
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=152 participants at risk
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=153 participants at risk
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.66%
1/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.00%
0/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Nervous system disorders
Syncope
|
0.00%
0/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.66%
1/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.00%
0/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Psychiatric disorders
Adjustment disorder with mixed disturbance of emotion and conduct
|
0.67%
1/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.00%
0/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.00%
0/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Psychiatric disorders
Aggression
|
0.67%
1/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.00%
0/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.00%
0/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Psychiatric disorders
Homicidal ideation
|
0.67%
1/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.00%
0/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.00%
0/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Psychiatric disorders
Self injurious behavior
|
0.67%
1/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.00%
0/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
0.00%
0/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
Other adverse events
| Measure |
SPD503-AM + Psychostimulant
n=150 participants at risk
Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
SPD503-PM + Psychostimulant
n=152 participants at risk
Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
|
Placebo + Psychostimulant
n=153 participants at risk
Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
21.3%
32/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
21.1%
32/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
13.1%
20/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Nervous system disorders
Somnolence
|
14.0%
21/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
13.2%
20/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
4.6%
7/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.3%
14/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
10.5%
16/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
7.8%
12/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
4/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
7.2%
11/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
3.3%
5/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
General disorders
Fatigue
|
12.0%
18/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
7.2%
11/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
2.6%
4/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Psychiatric disorders
Insomnia
|
5.3%
8/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
11.8%
18/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
3.9%
6/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
12/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
8.6%
13/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
2.0%
3/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Nervous system disorders
Dizziness
|
10.0%
15/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
5.3%
8/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
3.9%
6/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.0%
9/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
7.2%
11/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
3.9%
6/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
9/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
4.6%
7/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
4.6%
7/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
General disorders
Irritability
|
4.0%
6/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
5.9%
9/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
7.2%
11/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
General disorders
Pyrexia
|
4.0%
6/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
5.3%
8/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
3.9%
6/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Nervous system disorders
Sedation
|
3.3%
5/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
5.3%
8/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
2.0%
3/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.3%
2/150 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
5.3%
8/152 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
3.3%
5/153 • Up to 8 weeks
For the serious adverse events: syncope occurred in the context of nausea, vomiting and sinusitis; self-injurious behavior, aggression, homicidal ideation, and adjustment disorder with mixed disturbance of emotions and conduct in a subject with similar behaviors prior to study start; exposure to toxic agent was poison ivy.
|
Additional Information
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