Trial · NCT03260205
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
NCT03260205, Phase 3, Completed, Shire; results first posted 2020-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD). Trials, record NCT03260205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03260205
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT03260205
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 199 participants, actual
- Lead sponsor
- Shire
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- Placebo, SPD489 (Lisdexamfetamine dimesylate), SPD489
- First posted
- 2017-08-24
- Last updated
- 2021-06-08
- Results first posted
- 2020-01-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6 | Baseline, Week 6 | 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). Full analysis set (FAS) consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment. |
| Secondary | Clinical Global Impressions Global Improvement (CGI-I) at Week 6 | Week 6 | 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. FAS consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment. |
| Secondary | Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6 | Baseline, Week 6 | Dose response relationship was evaluated by using the ADHD-RS Preschool Version Total Score. 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 requires 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). Dose response analysis set consisted of all participants in the safety analysis set who had at least 1 valid primary efficacy measurement on the randomized target dose level of the investigational product. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (Week 7) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a investigational product (IP) and that does not necessarily had a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of IP and no later than 3 days following the last dose of IP. |
| Secondary | Number of Participants With Potentially Clinically Significant Changes in Vital Signs | Week 6 | Vital sign assessments included blood pressure (systolic and diastolic), average pulse rate. Number of participants with potentially clinically significant changes in vital signs were reported. mmHg represents millimetre of mercury in the outcome measure data. |
| Secondary | Change From Baseline in Height at Week 6 | Baseline, Week 6 | Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor. |
| Secondary | Change From Baseline in Body Weight at Week 6 | Baseline, Week 6 | Body weight was measured in percentile without shoes. Body weight percentile was normalized by sex and age using the Centers for Disease Control and Prevention (CDC) growth charts. Body weight percentiles were categorized as lesser than (\<) 5th, 5th to \< 95th, and greater than or equal to (\>=) 95th percentiles. Change from baseline in body weight at Week 6 was reported. |
| Secondary | Change From Baseline in Body Mass Index (BMI) at Week 6 | Baseline, Week 6 | BMI was derived from height and weight. BMI percentile 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). Change from baseline in body mass index at Week 6 was reported. |
| Secondary | Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values | Week 6 | Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. ULN in measure data represents upper limit of normal, mcmol/L represents to Micromoles Per Litre, \> = represents greater than or equal to. |
| Secondary | Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Week 6 | Number of participants with potentially clinically significant changes in ECG parameters were reported. QTcF interval represents QT Fridericia's Correction Formula interval, QTcB interval represents QTc corrected by Bazett's in measure data. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6 | Baseline, Week 6 | Full analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. This outcome was pre-specified to collect and analyze pooled groups of SPD489 doses. The data were planned, analyzed, and reported only for the placebo and the pooled 10, 20, 30 mg doses of SPD489 arms. | Score on a scale | MEAN |
| SECONDARY | Clinical Global Impressions Global Improvement (CGI-I) at Week 6 | Week 6 | Full analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. This outcome was pre-specified to collect and analyze pooled groups of SPD489 doses. The data were planned, analyzed, and reported only for the placebo and the pooled 10, 20, 30 mg doses of SPD489 arms. | Score on a scale | MEAN |
| SECONDARY | Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6 | Baseline, Week 6 | Dose response analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Each SPD489 arm is compared with placebo sequentially, with the highest dose level first. | Score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (Week 7) | Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Changes in Vital Signs | Week 6 | Safety analysis set consisted of all randomized set who had taken 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 |
| SECONDARY | Change From Baseline in Height at Week 6 | Baseline, Week 6 | Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Centimeter | MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 6 | Baseline, Week 6 | Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Weight percentile | MEAN |
| SECONDARY | Change From Baseline in Body Mass Index (BMI) at Week 6 | Baseline, Week 6 | Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | BMI percentile | MEAN |
| SECONDARY | Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values | Week 6 | Safety analysis set consisted of all randomized set who had taken 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 |
| SECONDARY | Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Week 6 | Safety analysis set consisted of all randomized set who had taken 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group224
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 Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6 | Placebo | -9.1 | Standard Error 2.36 | Score on a scale | |
| Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6 | Pooled SPD489 Doses (10, 20, and 30 mg) | -14.2 | Standard Error 1.57 | Score on a scale | |
| Clinical Global Impressions Global Improvement (CGI-I) at Week 6 | Placebo | 3.4 | Standard Error 0.18 | Score on a scale | |
| Clinical Global Impressions Global Improvement (CGI-I) at Week 6 | Pooled SPD489 Doses (10, 20, and 30 mg) | 2.8 | Standard Error 0.13 | Score on a scale | |
| Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6 | Placebo | -9.1 | Standard Error 2.36 | Score on a scale | |
| Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6 | SPD489 30 mg | -15.3 | Standard Error 2.62 | Score on a scale | |
| Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6 | SPD489 20 mg | -17.0 | Standard Error 2.90 | Score on a scale | |
| Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6 | SPD489 10 mg | -10.8 | Standard Error 2.63 | Score on a scale | |
| Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6 | SPD489 5 mg | -13.5 | Standard Error 2.53 | Score on a scale | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | 19 | Participants |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 46 | |
| Overall Study | STARTED | SPD489 5 mg | 40 | |
| Overall Study | STARTED | SPD489 10 mg | 37 | |
| Overall Study | STARTED | SPD489 20 mg | 37 | |
| Overall Study | STARTED | SPD489 30 mg | 39 | |
| Overall Study | Received Treatment | Placebo | 45 | |
| Overall Study | Received Treatment | SPD489 5 mg | 39 | |
| Overall Study | Received Treatment | SPD489 10 mg | 35 | |
| Overall Study | Received Treatment | SPD489 20 mg | 34 | |
| Overall Study | Received Treatment | SPD489 30 mg | 38 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events75
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 | Constipation | Gastrointestinal disorders | Placebo | 1 | 45 | 1 |
| other | Constipation | Gastrointestinal disorders | SPD489 5 mg | 0 | 39 | 0 |
| other | Constipation | Gastrointestinal disorders | SPD489 10 mg | 0 | 35 | 0 |
| other | Constipation | Gastrointestinal disorders | SPD489 20 mg | 2 | 34 | 2 |
| other | Constipation | Gastrointestinal disorders | SPD489 30 mg | 0 | 38 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
| other | Dry mouth | Gastrointestinal disorders | SPD489 5 mg | 2 | 39 | 2 |
| other | Dry mouth | Gastrointestinal disorders | SPD489 10 mg | 0 | 35 | 0 |
| other | Dry mouth | Gastrointestinal disorders | SPD489 20 mg | 0 | 34 | 0 |
| other | Dry mouth | Gastrointestinal disorders | SPD489 30 mg | 0 | 38 | 0 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 45 |
| Total, all-cause mortality | SPD489 5 mg | 0 | 39 |
| Total, all-cause mortality | SPD489 10 mg | 0 | 35 |
| Total, all-cause mortality | SPD489 20 mg | 0 | 34 |
| Total, all-cause mortality | SPD489 30 mg | 0 | 38 |
| Total, other adverse events | Placebo | 4 | 45 |
| Total, other adverse events | SPD489 5 mg | 8 | 39 |
| Total, other adverse events | SPD489 10 mg | 11 | 35 |
| Total, other adverse events | SPD489 20 mg | 14 | 34 |
| Total, other adverse events | SPD489 30 mg | 18 | 38 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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.
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