Trial · NCT02466386
Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder
NCT02466386, Phase 3, Completed, Shire; results first posted 2021-03-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder. Trials, record NCT02466386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02466386
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder
- NCT number
- NCT02466386
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 113 participants, actual
- Lead sponsor
- Shire
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- SPD489
- First posted
- 2015-06-09
- Last updated
- 2021-03-05
- Results first posted
- 2021-03-05
Source ClinicalTrials.gov
Registered outcomes9
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) | From start of study drug administration up to follow-up (Week 53) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of investigational product. |
| Primary | Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET) | Week 52/ET | Sleep patterns included sleep diary data and children's sleep habits questionnaire (CSHQ), which was parent report questionnaire designed to screen for the most common sleep problems in children, and consisted of 33 items for scoring and several extra items intended to provide administrators with other potentially useful information about respondents. The instrument evaluates the child's sleep based on behavior within 8 different sub scales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night wakings, 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, and daytime sleepiness: 8 to 24. |
| Primary | Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET) | Week 52/ET | 12-lead ECG was evaluated and recorded. ECG variables included heart rate, PR interval, QRS interval, QT interval, and corrected QT interval (QTc). The QTc was calculated using both Bazett (QTcB=QT/\[RR\]1/2) and Fridericia (QTcF=QT/\[RR\]1/3) corrections. Here, \> = represents "greater than or equal to", \< represents "lesser than" and \> represents "greater than". |
| Primary | Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS) at Week 52/ Early Termination (ET) | Week 52/ET | C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported. |
| Primary | Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values at Week 52/ Early Termination (ET) | Week 52/ET | Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. |
| Primary | Number of Participants With Potentially Clinically Significant Changes in Vital Signs at Week 52/ Early Termination (ET) | Week 52/ET | Vital sign assessments included blood pressure, pulse and respiratory rate. Number of participants with potentially clinically significant changes in vital signs were reported. |
| Primary | Number of Participants With Shift From Baseline in Body Mass Index (BMI) Percentiles at Week 52/Early Termination (ET) | Week 52/ET | BMI was derived from height and weight. BMI was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI \< 5th percentile); Healthy weight (BMI 5th percentile up to \< 85th percentile); Overweight (BMI 85th percentile \< 95th percentile); Obese (BMI \>= 95th percentile). Number of participants with shift from baseline in BMI percentile categories at Week 52/ET was reported. |
| Secondary | Clinical Global Impressions Global Improvement (CGI-I) at Week 52/ Early Termination (ET) | Week 52/ET | CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
| Secondary | Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 52/ Early Termination (ET) | Week 52/ET | ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was 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 were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). |
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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (Week 53) | Safety analysis set consisted of all participants who took at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET) | Week 52/ET | Safety analysis set consisted of all participants who took at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories. | Score on scale | MEAN |
| PRIMARY | Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET) | Week 52/ET | Safety analysis set consisted of all participants who took at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS) at Week 52/ Early Termination (ET) | Week 52/ET | Safety analysis set consisted of all participants who took at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values at Week 52/ Early Termination (ET) | Week 52/ET | Safety analysis set consisted of all participants who took at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and at the specific categories. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Changes in Vital Signs at Week 52/ Early Termination (ET) | Week 52/ET | Safety analysis set consisted of all participants who took at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Global Impressions Global Improvement (CGI-I) at Week 52/ Early Termination (ET) | Week 52/ET | Full analysis set consisted of all participants in the safety analysis set who took at least 1 post-dose ADHD-RS-IV Preschool Version Total Score assessment during the study. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 52/ Early Termination (ET) | Week 52/ET | Full analysis set consisted of all participants in the safety analysis set who took at least 1 post-dose ADHD-RS-IV Preschool Version Total Score assessment during the study. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on a scale | MEAN |
| PRIMARY | Number of Participants With Shift From Baseline in Body Mass Index (BMI) Percentiles at Week 52/Early Termination (ET) | Week 52/ET | Safety analysis set consisted of all participants who took at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group46
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) | SPD489 | 86 | Participants | ||
| Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET) | SPD489 | Bedtime Resistance: Week 52/ET | 8.9 | Standard Deviation 3.04 | Score on scale |
| Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET) | SPD489 | Sleep-onset Delay: Week 52/ET | 1.6 | Standard Deviation 0.67 | Score on scale |
| Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET) | SPD489 | Sleep Duration: Week 52/ET | 3.8 | Standard Deviation 1.26 | Score on scale |
| Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET) | SPD489 | Sleep Anxiety: Week 52/ET | 5.5 | Standard Deviation 2.09 | Score on scale |
| Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET) | SPD489 | Night Wakings: Week 52/ET | 4.2 | Standard Deviation 1.59 | Score on scale |
| Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET) | SPD489 | Parasomnias: Week 52/ET | 8.6 | Standard Deviation 1.54 | Score on scale |
| Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET) | SPD489 | Sleep-disordered Breathing: Week 52/ET | 3.4 | Standard Deviation 0.74 | Score on scale |
| Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET) | SPD489 | Daytime Sleepiness: Week 52/ET | 10.1 | Standard Deviation 3.78 | Score on scale |
| Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET) | SPD489 | Heart Rate (< 55 Beats per minute) | 0 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 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 | 113 | |
| Overall Study | COMPLETED | SPD489 | 69 | |
| Overall Study | NOT COMPLETED | SPD489 | 44 |
Source ClinicalTrials.gov
Adverse events11
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 | Vomiting | Gastrointestinal disorders | Total | 6 | 113 | 7 |
| other | Pyrexia | General disorders | Total | 11 | 113 | 12 |
| other | Influenza | Infections and infestations | Total | 10 | 113 | 10 |
| other | Nasopharyngitis | Infections and infestations | Total | 8 | 113 | 11 |
| other | Pharyngitis streptococcal | Infections and infestations | Total | 9 | 113 | 11 |
| other | Upper respiratory tract infection | Infections and infestations | Total | 8 | 113 | 15 |
| other | Weight decreased | Investigations | Total | 7 | 113 | 7 |
| other | Decreased appetite | Metabolism and nutrition disorders | Total | 18 | 113 | 21 |
| other | Affect lability | Psychiatric disorders | Total | 7 | 113 | 8 |
| other | Initial insomnia | Psychiatric disorders | Total | 6 | 113 | 7 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total | 0 | 113 |
| Total, other adverse events | Total | 57 | 113 |
| Total, serious adverse events | Total | 0 | 113 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35230142 | 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.
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