Trial · NCT03325881
Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years
NCT03325881, Phase 3, Completed, Shire; results first posted 2019-08-13
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ConductScience Library. Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years. Trials, record NCT03325881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03325881
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years
- NCT number
- NCT03325881
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 89 participants, actual
- Lead sponsor
- Shire
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- SHP465, Placebo
- First posted
- 2017-10-30
- Last updated
- 2021-06-02
- Results first posted
- 2019-08-13
Source ClinicalTrials.gov
Registered outcomes11
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-5 (ADHD-RS-5) Total Score at Week 4 | Baseline, Week 4 | Clinician administered ADHD-RS-5, child, home version total score were analyzed. ADHD-RS-5 consisted of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity or impulsivity (9 items) and inattentiveness (9 items). Higher total scores indicated higher impairment and lower scores indicated no impairment. Least square (LS) mean was calculated based on restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance type. |
| Secondary | Clinical Global Impression of Improvement (CGI-I) at Week 4 | Week 4 | CGI scale was measured to rate the overall improvement of a participants condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). LS mean was calculated based on restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance type. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (Week 5) | 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 were 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. |
| Secondary | Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE) | From start of study drug administration up to follow-up (Week 5) | Vital sign assessments included systolic and diastolic blood pressure and pulse. Participants with clinically significant deviations from baseline values which are deemed clinically significant in the opinion of the investigator were considered as AE's. An 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. |
| Secondary | Number of Participants With Clinically Significant Change in Clinical Laboratory Test Results Assessed by the Investigator | From start of study drug administration up to follow-up (Week 5) | Clinical laboratory tests included biochemistry, endocrinology, hematology and urinalysis. The investigator assessed out-of-range clinical laboratory values for clinical significance, if the value(s) were not clinically significant or clinically significant. |
| Secondary | Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Assessed by the Investigator | From start of study drug administration up to follow-up (Week 5) | Participants with clinically significant deviations from baseline values which are deemed clinically significant in the opinion of the investigator were considered in 12-lead ECG and reported. |
| Secondary | Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Baseline and Week 4 | Baseline, Week 4 | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. Participants analyzed for number of times woke up per night category were only the participants who responded as yes for the woke up during the night category in this outcome measure. |
| Secondary | Change From Baseline in Length of Time Awake Per Night and Length of Time to Fall Asleep Per Night Assessed by PSQ at Week 4 | Baseline, Week 4 | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. |
| Secondary | Change From Baseline in Length of Time Sleeping Per Night Assessed by PSQ at Week 4 | Baseline, Week 4 | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. |
| Secondary | Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Week 4 | Week 4 | The CSHQ is a validated, retrospective, parent-reported sleep screening tool. The questionnaire consists of 35 items that yield a TSD score, as well as 8 subscale scores, including bedtime resistance, sleep duration, parasomnias, sleep disordered breathing, night wakings, daytime sleepiness, sleep anxiety, and sleep onset delay. Parents were asked to think of a recent "typical" week of their child's sleep and to indicate how often sleep disturbance behaviors occurred. A 3-point scale was used for rating: "usually" if the sleep behavior occurs 5 to 7 times per week, "sometimes" for 2 to 4 times per week, and "rarely" for once or not at all during the week. The TSD score, which is the sum of all responses, included all items of the 8 subscales, but consisted of only 33 items because two on the bedtime resistance and sleep anxiety subscales were identical (range: 0, 99). A negative value indicates less sleep disturbance. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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-5 (ADHD-RS-5) Total Score at Week 4 | Baseline, Week 4 | Full analysis set consisted of all participants in the safety set who had baseline ADHD-RS-5 total score and at least 1 postdose ADHD-RS-5 total score. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression of Improvement (CGI-I) at Week 4 | Week 4 | Full analysis set consisted of all participants in the safety set who had baseline ADHD-RS-5 total score and at least 1 postdose ADHD-RS-5 total score. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (Week 5) | Safety set consisted of all participants in the randomized set who as taken at least 1 dose of investigator product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE) | From start of study drug administration up to follow-up (Week 5) | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Change in Clinical Laboratory Test Results Assessed by the Investigator | From start of study drug administration up to follow-up (Week 5) | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Assessed by the Investigator | From start of study drug administration up to follow-up (Week 5) | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Baseline and Week 4 | Baseline, Week 4 | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Length of Time Awake Per Night and Length of Time to Fall Asleep Per Night Assessed by PSQ at Week 4 | Baseline, Week 4 | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | minutes | MEAN |
| SECONDARY | Change From Baseline in Length of Time Sleeping Per Night Assessed by PSQ at Week 4 | Baseline, Week 4 | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | hours | MEAN |
| SECONDARY | Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Week 4 | Week 4 | Safety set consisted of all participants in the randomized set who took at least 1 dose of SHP465. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Units on scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group104
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-5 (ADHD-RS-5) Total Score at Week 4 | Placebo | -9.7 | 95% Confidence Interval -13.2 to -6.2 | Score on a scale | |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Week 4 | SHP465 | -11.6 | 95% Confidence Interval -15.0 to -8.2 | Score on a scale | |
| Clinical Global Impression of Improvement (CGI-I) at Week 4 | Placebo | 3.3 | 95% Confidence Interval 3.0 to 3.6 | Score on a scale | |
| Clinical Global Impression of Improvement (CGI-I) at Week 4 | SHP465 | 3.2 | 95% Confidence Interval 2.9 to 3.5 | Score on a scale | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | 7 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | SHP465 | 11 | Participants | ||
| Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE) | Placebo | Number of participants with secondary hypertension | 1 | Participants | |
| Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE) | SHP465 | Number of participants with secondary hypertension | 0 | Participants | |
| Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE) | Placebo | Number of participants with Tachycardia | 1 | Participants | |
| Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE) | SHP465 | Number of participants with Tachycardia | 0 | Participants |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 44 | |
| Overall Study | STARTED | SHP465 | 45 | |
| Overall Study | Treated | Placebo | 43 | |
| Overall Study | Treated | SHP465 | 45 | |
| Overall Study | COMPLETED | Placebo | 41 | |
| Overall Study | COMPLETED | SHP465 | 42 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | SHP465 | 3 |
Source ClinicalTrials.gov
Adverse events2
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 | Placebo | 3 | 43 | 4 |
| other | Headache | Nervous system disorders | SHP465 | 2 | 45 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 43 |
| Total, all-cause mortality | SHP465 | 0 | 45 |
| Total, other adverse events | Placebo | 3 | 43 |
| Total, other adverse events | SHP465 | 2 | 45 |
| Total, serious adverse events | Placebo | 0 | 43 |
| Total, serious adverse events | SHP465 | 0 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33185468 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SHP465 vs Placebo: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Assessed by the Investigator | Trial comparisons |
| SHP465 vs Placebo: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| SHP465 vs Placebo: Number of Participants With Clinically Significant Change in Clinical Laboratory Test Results Assessed by the Investigator | Trial comparisons |
| SHP465 vs Placebo: deaths from any cause | Trial comparisons |
| SHP465 vs Placebo: serious adverse events | Trial comparisons |
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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