Trial · NCT00734578
Efficacy and Safety of SPD503 in Combination With Psychostimulants
NCT00734578, Phase 3, Completed, Shire; results first posted 2010-11-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of SPD503 in Combination With Psychostimulants. Trials, record NCT00734578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00734578
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of SPD503 in Combination With Psychostimulants
- NCT number
- NCT00734578
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 461 participants, actual
- Lead sponsor
- Shire
- Conditions
- ADHD
- Interventions
- SPD503-AM, SPD503-PM, Placebo
- First posted
- 2008-08-14
- Last updated
- 2021-06-14
- Results first posted
- 2010-11-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | Baseline and weekly up to 8 weeks | 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. |
| Secondary | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF | Baseline and weekly up to 8 weeks | 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. |
| Secondary | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Baseline and weekly up to 8 weeks | 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) |
| Secondary | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School) | Baseline and weekly up to 8 weeks | 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. |
| Secondary | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime) | Baseline and weekly up to 8 weeks | 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. |
| Secondary | Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF | Baseline and week 8 | 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. |
| Secondary | Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF | Baseline and weekly up to 8 weeks | 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. |
| Secondary | Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF | Baseline and weekly up to 8 weeks | 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. |
| Secondary | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Baseline and weekly up to 8 weeks | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Baseline and weekly up to 8 weeks | Full Analysis Set (FAS) which includes all subjects who received at least 1 dose of any study drug during this study. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF | Baseline and weekly up to 8 weeks | FAS | Percent of participants | NUMBER |
| SECONDARY | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Baseline and weekly up to 8 weeks | FAS | Percent of participants | NUMBER |
| SECONDARY | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School) | Baseline and weekly up to 8 weeks | FAS | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime) | Baseline and weekly up to 8 weeks | FAS | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF | Baseline and week 8 | FAS | Percent of participants | NUMBER |
| SECONDARY | Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF | Baseline and weekly up to 8 weeks | FAS | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF | Baseline and weekly up to 8 weeks | FAS | Units on a scale | MEAN |
| SECONDARY | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Baseline and weekly up to 8 weeks | FAS | Percent of participants | NUMBER |
Source ClinicalTrials.gov
Results by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | SPD503-AM + Psychostimulant | -20.4 | Standard Deviation 12.77 | Units on a scale | |
| 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) | SPD503-PM + Psychostimulant | -21.0 | Standard Deviation 12.39 | Units on a scale | |
| 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) | Placebo + Psychostimulant | -16.0 | Standard Deviation 11.77 | Units on a scale | |
| Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF | SPD503-AM + Psychostimulant | 70.5 | Percent of participants | ||
| Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF | SPD503-PM + Psychostimulant | 74.3 | Percent of participants | ||
| Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF | Placebo + Psychostimulant | 57.9 | Percent of participants | ||
| Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | SPD503-AM + Psychostimulant | Normal, not at all ill | 22.8 | Percent of participants | |
| Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | SPD503-PM + Psychostimulant | Normal, not at all ill | 25.0 | Percent of participants | |
| Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | Placebo + Psychostimulant | Normal, not at all ill | 15.1 | Percent of participants | |
| Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | SPD503-AM + Psychostimulant | Borderline mentally ill | 19.5 | Percent of participants |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPD503-AM + Psychostimulant | 154 | |
| Overall Study | STARTED | SPD503-PM + Psychostimulant | 153 | |
| Overall Study | STARTED | Placebo + Psychostimulant | 154 | |
| Overall Study | COMPLETED | SPD503-AM + Psychostimulant | 121 | |
| Overall Study | COMPLETED | SPD503-PM + Psychostimulant | 128 | |
| Overall Study | COMPLETED | Placebo + Psychostimulant | 129 | |
| Overall Study | NOT COMPLETED | SPD503-AM + Psychostimulant | 33 | |
| Overall Study | NOT COMPLETED | SPD503-PM + Psychostimulant | 25 | |
| Overall Study | NOT COMPLETED | Placebo + Psychostimulant | 25 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | SPD503-AM + Psychostimulant | 32 | 150 | |
| other | Headache | Nervous system disorders | SPD503-PM + Psychostimulant | 32 | 152 | |
| other | Headache | Nervous system disorders | Placebo + Psychostimulant | 20 | 153 | |
| other | Somnolence | Nervous system disorders | SPD503-AM + Psychostimulant | 21 | 150 | |
| other | Somnolence | Nervous system disorders | SPD503-PM + Psychostimulant | 20 | 152 | |
| other | Somnolence | Nervous system disorders | Placebo + Psychostimulant | 7 | 153 | |
| other | Upper respiratory tract infection | Infections and infestations | SPD503-AM + Psychostimulant | 14 | 150 | |
| other | Upper respiratory tract infection | Infections and infestations | SPD503-PM + Psychostimulant | 16 | 152 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo + Psychostimulant | 12 | 153 | |
| other | Nausea | Gastrointestinal disorders | SPD503-AM + Psychostimulant | 4 | 150 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD503-AM + Psychostimulant | ||
| Total, all-cause mortality | SPD503-PM + Psychostimulant | ||
| Total, all-cause mortality | Placebo + Psychostimulant | ||
| Total, other adverse events | SPD503-AM + Psychostimulant | 116 | 150 |
| Total, other adverse events | SPD503-PM + Psychostimulant | 116 | 152 |
| Total, other adverse events | Placebo + Psychostimulant | 97 | 153 |
| Total, serious adverse events | SPD503-AM + Psychostimulant | 1 | 150 |
| Total, serious adverse events | SPD503-PM + Psychostimulant | 2 | 152 |
| Total, serious adverse events | Placebo + Psychostimulant | 0 | 153 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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