Trial · NCT02402166
Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder
NCT02402166, Phase 2, Completed, Shire; results first posted 2018-10-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder. Trials, record NCT02402166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02402166
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder
- NCT number
- NCT02402166
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Shire
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- SPD489
- First posted
- 2015-03-30
- Last updated
- 2021-06-08
- Results first posted
- 2018-10-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level | From start of study treatment up to safety follow-up (Week 9) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment-emergent if it had a start date on or after, or had a start date before but increased in severity after the first dose of investigational product. |
| Primary | Change in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire at Week 8 / End of Treatment (ET) | Baseline, Week 8/ET | Children's Sleep Habits Questionnaire is a tool designed to screen the most common sleep problems in children, and consists of 33 items for scoring. The instrument evaluates the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99. |
| Primary | Number of Participants With Suicide Related Behavior Assessed by Columbia-Suicide Severity Rating Scale Questionnaire (C-SSRS) | Baseline, Week 8/ET | The C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "No," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide. |
| Secondary | Change From Baseline in Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Preschool Version Total Score at FoTA (Final on Treatment Assessment) | Baseline, FoTA | The ADHD-RS-IV Preschool Version is an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Data presented here was analysed at Final on-Treatment Assessment (FoTA). |
| Secondary | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) | FoTA | CGI-I was performed to rate the severity of a participant's condition on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse). Data presented here was analysed at Final on-Treatment Assessment (FoTA). Improved is defined as a score of "very much improved" or "much improved". |
| Secondary | Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-last) of SPD489 in Plasma | Visit 7 [Dose Maintenance Phase] at pre-dose, and 1, 2, 3, 4, 6, and 8 h post-dose | AUC 0-last is the area under the concentration-time curve from time zero to the time of the last quantifiable concentration of SPD489 in plasma. Pharmacokinetic (PK) parameters were compared against the study NRP104-201 (NCT00557011) to observe and compare the effects of SPD489. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level | From start of study treatment up to safety follow-up (Week 9) | Safety analysis set consisted of all participants who had taken at least 1 dose of investigational product. Reporting groups are defined by the dose taken prior to the onset of the TEAE (Treatment Emergent Adverse Event). Number of participants analysed (N) are specific to the reporting group at the specific dose level. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire at Week 8 / End of Treatment (ET) | Baseline, Week 8/ET | Safety analysis set consisted of all participants who had taken at least 1 dose of investigational product. Here number of participant analysed for the each sub-scale is specified for this endpoint. | Units on a Scale | MEAN |
| PRIMARY | Number of Participants With Suicide Related Behavior Assessed by Columbia-Suicide Severity Rating Scale Questionnaire (C-SSRS) | Baseline, Week 8/ET | Safety analysis set consisted of all participants who had taken at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Preschool Version Total Score at FoTA (Final on Treatment Assessment) | Baseline, FoTA | Full analysis set consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD-RS-IV Preschool Version total score assessment. | Units on a Scale | MEAN |
| SECONDARY | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) | FoTA | Full analysis set consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD-RS-IV Preschool Version total score assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-last) of SPD489 in Plasma | Visit 7 [Dose Maintenance Phase] at pre-dose, and 1, 2, 3, 4, 6, and 8 h post-dose | The PK set consisted all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable. PK assessments were performed only during the Dose Maintenance Period (2 weeks) for SPD 489 10, 15 and 30 mg reporting groups. | hour*nanogram/millilitre(h*ng/mL) | MEAN |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level | SPD489 5 mg | 10 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level | SPD489 10 mg | 11 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level | SPD489 15 mg | 7 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level | SPD489 20 mg | 6 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level | SPD489 30 mg | 6 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level | SPD489 | 19 | Participants | ||
| Change in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire at Week 8 / End of Treatment (ET) | SPD489 | Baseline : Bedtime resistance | 9.9 | Standard Deviation 3.58 | Units on a Scale |
| Change in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire at Week 8 / End of Treatment (ET) | SPD489 | Week 8/ End of Treatment (ET) : Bedtime resistance | 9.5 | Standard Deviation 3.26 | Units on a Scale |
| Change in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire at Week 8 / End of Treatment (ET) | SPD489 | Baseline : Sleep-onset delay | 1.9 | Standard Deviation 0.85 | Units on a Scale |
| Change in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire at Week 8 / End of Treatment (ET) | SPD489 | Week 8/ ET : Sleep-onset delay | 1.8 | Standard Deviation 0.92 | Units on a Scale |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPD489 | 24 | |
| Overall Study | COMPLETED | SPD489 | 19 | |
| Overall Study | NOT COMPLETED | SPD489 | 5 |
Source ClinicalTrials.gov
Adverse events108
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 | Abdominal pain upper | Gastrointestinal disorders | SPD489 5mg | 1 | 24 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | SPD489 10mg | 1 | 23 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | SPD489 15mg | 0 | 18 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | SPD489 20mg | 1 | 12 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | SPD489 30mg | 0 | 10 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | SPD489 | 3 | 24 | 3 |
| other | Vomiting | Gastrointestinal disorders | SPD489 5mg | 0 | 24 | 0 |
| other | Vomiting | Gastrointestinal disorders | SPD489 10mg | 0 | 23 | 0 |
| other | Vomiting | Gastrointestinal disorders | SPD489 15mg | 0 | 18 | 0 |
| other | Vomiting | Gastrointestinal disorders | SPD489 20mg | 0 | 12 | 0 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD489 5mg | 0 | 24 |
| Total, all-cause mortality | SPD489 10mg | 0 | 23 |
| Total, all-cause mortality | SPD489 15mg | 0 | 18 |
| Total, all-cause mortality | SPD489 20mg | 0 | 12 |
| Total, all-cause mortality | SPD489 30mg | 0 | 10 |
| Total, all-cause mortality | SPD489 | 0 | 24 |
| Total, other adverse events | SPD489 5mg | 6 | 24 |
| Total, other adverse events | SPD489 10mg | 7 | 23 |
| Total, other adverse events | SPD489 15mg | 7 | 18 |
| Total, other adverse events | SPD489 20mg | 6 | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32233956 | DERIVED |
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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