Trial · NCT00150618
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
NCT00150618, Phase 3, Completed, Shire; results first posted 2009-10-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17. Trials, record NCT00150618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00150618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
- NCT number
- NCT00150618
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 324 participants, actual
- Lead sponsor
- Shire
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- SPD503 (1 mg), SPD503 (2 mg), SPD503 (3 mg), SPD503 (4 mg), Placebo
- First posted
- 2005-09-08
- Last updated
- 2021-06-10
- Results first posted
- 2009-10-15
Source ClinicalTrials.gov
Registered outcomes5
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 (ADHD-RS-IV) Score at 6 Weeks | Baseline and 6 weeks | Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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 | Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks | Baseline and 6 weeks | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. |
| Secondary | Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) | 6 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 | Number of Participants With Improvement in Parent Global Assessment (PGA) | 6 weeks | 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 Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks | Baseline and 6 weeks | The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. |
Source ClinicalTrials.gov
Outcomes5
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 (ADHD-RS-IV) Score at 6 Weeks | Baseline and 6 weeks | Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the Baseline and at least one post-randomization primary efficacy measurement. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks | Baseline and 6 weeks | ITT | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) | 6 weeks | ITT | Participants | NUMBER |
| SECONDARY | Number of Participants With Improvement in Parent Global Assessment (PGA) | 6 weeks | ITT | Participants | NUMBER |
| SECONDARY | Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks | Baseline and 6 weeks | ITT | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group30
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 (ADHD-RS-IV) Score at 6 Weeks | SPD503 (1 mg) | -19.44 | Standard Error 1.69 | Units on a Scale | |
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks | SPD503 (2 mg) | -18.09 | Standard Error 1.60 | Units on a Scale | |
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks | SPD503 (3 mg) | -20.00 | Standard Error 1.64 | Units on a Scale | |
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks | SPD503 (4 mg) | -20.57 | Standard Error 1.60 | Units on a Scale | |
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks | Placebo | -12.69 | Standard Error 1.60 | Units on a Scale | |
| Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks | SPD503 (1 mg) | -19.50 | Standard Error 2.36 | Units on a Scale | |
| Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks | SPD503 (2 mg) | -14.96 | Standard Error 2.29 | Units on a Scale | |
| Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks | SPD503 (3 mg) | -17.94 | Standard Error 2.48 | Units on a Scale | |
| Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks | SPD503 (4 mg) | -15.93 | Standard Error 2.34 | Units on a Scale | |
| Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks | Placebo | -8.41 | Standard Error 2.34 | Units on a Scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPD503 (1 mg) | 62 | |
| Overall Study | STARTED | SPD503 (2 mg) | 65 | |
| Overall Study | STARTED | SPD503 (3 mg) | 65 | |
| Overall Study | STARTED | SPD503 (4 mg) | 66 | |
| Overall Study | STARTED | Placebo | 66 | |
| Overall Study | COMPLETED | SPD503 (1 mg) | 45 | |
| Overall Study | COMPLETED | SPD503 (2 mg) | 47 | |
| Overall Study | COMPLETED | SPD503 (3 mg) | 38 | |
| Overall Study | COMPLETED | SPD503 (4 mg) | 40 | |
| Overall Study | COMPLETED | Placebo | 41 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events85
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 | Upper abdominal pain | Gastrointestinal disorders | SPD503 (1 mg) | 5 | 61 | |
| other | Upper abdominal pain | Gastrointestinal disorders | SPD503 (2 mg) | 2 | 65 | |
| other | Upper abdominal pain | Gastrointestinal disorders | SPD503 (3 mg) | 1 | 65 | |
| other | Upper abdominal pain | Gastrointestinal disorders | SPD503 (4 mg) | 8 | 65 | |
| other | Upper abdominal pain | Gastrointestinal disorders | Placebo | 6 | 66 | |
| other | Dry mouth | Gastrointestinal disorders | SPD503 (1 mg) | 0 | 61 | |
| other | Dry mouth | Gastrointestinal disorders | SPD503 (2 mg) | 0 | 65 | |
| other | Dry mouth | Gastrointestinal disorders | SPD503 (3 mg) | 1 | 65 | |
| other | Dry mouth | Gastrointestinal disorders | SPD503 (4 mg) | 5 | 65 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 66 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD503 (1 mg) | ||
| Total, all-cause mortality | SPD503 (2 mg) | ||
| Total, all-cause mortality | SPD503 (3 mg) | ||
| Total, all-cause mortality | SPD503 (4 mg) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | SPD503 (1 mg) | 49 | 61 |
| Total, other adverse events | SPD503 (2 mg) | 40 | 65 |
| Total, other adverse events | SPD503 (3 mg) | 45 | 65 |
| Total, other adverse events | SPD503 (4 mg) | 55 | 65 |
| Total, other adverse events | Placebo | 45 | 66 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19106767 | RESULT |
Source PubMed
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00150618
GET https://conductscience.org/api/trials/v1/NCT00150618/results?page=2