A Phase 3 interventional study of SHP465 and Placebo in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire. Completed at 41 sites in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-06-02.
Sponsored by Shire (part of Takeda) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's enrollment of 89 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Shire is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
Of its 48 completed or terminated interventional studies of FDA-regulated products, 48 (100%) have results posted.
First submitted before Shire became part of Takeda.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomized to receive SHP465 capsule 6.25 milligram (mg) orally once daily for 4 weeks.
Drug: SHP465
Participant will receive placebo matching to SHP465 capsule orally once daily for 4 weeks.
Drug: Placebo
SHP465 capsule 6.25 mg orally once daily for 4 weeks
Placebo matching to SHP465 capsule orally once daily for 4 weeks
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at 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.
Time frame: Baseline, Week 4
Clinical Global Impression of Improvement (CGI-I) at 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.
Time frame: Week 4
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: From start of study drug administration up to follow-up (Week 5)
Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE)
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.
Time frame: From start of study drug administration up to follow-up (Week 5)
Number of Participants With Clinically Significant Change in Clinical Laboratory Test Results Assessed by the Investigator
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.
Time frame: From start of study drug administration up to follow-up (Week 5)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Assessed by the Investigator
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.
Time frame: From start of study drug administration up to follow-up (Week 5)
Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Baseline and 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.
Time frame: Baseline, Week 4
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
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.
Time frame: Baseline, Week 4
Change From Baseline in Length of Time Sleeping Per Night Assessed by PSQ at 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.
Time frame: Baseline, Week 4
Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at 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.
Time frame: Week 4
Number of Participants With a Positive Response in Columbia-suicide Severity Rating Scale (C-SSRS) at Week 4
C-SSRS was a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The number of participants with clinical significant change in suicidal ideation and suicidal behavior were reported.
Time frame: Week 4
The study was conducted at 43 study centers in the United States between 09 December 2017 (first participant first visit) and 07 June 2018 (last participant last visit).
| Milestone | Placebo | SHP465 |
|---|---|---|
| Started | 44 | 45 |
| Treated | 43 | 45 |
| Completed | 41 | 42 |
| Not completed | 3 | 3 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Not treated | 1 | 0 |
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.
| Score on a scale | Placebo | SHP465 |
|---|---|---|
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Week 4 | -9.7 (-13.2 to -6.2) | -11.6 (-15.0 to -8.2) |
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.
| Score on a scale | Placebo | SHP465 |
|---|---|---|
| Clinical Global Impression of Improvement (CGI-I) at Week 4 | 3.3 (3.0 to 3.6) | 3.2 (2.9 to 3.5) |
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.
| Participants | Placebo | SHP465 |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 7 | 11 |
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.
| Participants | Placebo | SHP465 |
|---|---|---|
| Number of participants with secondary hypertension | 1 | 0 |
| Number of participants with Tachycardia | 1 | 0 |
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.
| Participants | Placebo | SHP465 |
|---|---|---|
| Number of Participants With Clinically Significant Change in Clinical Laboratory Test Results Assessed by the Investigator | 0 | 0 |
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.
| Participants | Placebo | SHP465 |
|---|---|---|
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Assessed by the Investigator | 0 | 0 |
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.
| Participants | Placebo | SHP465 |
|---|---|---|
| Baseline: Woke up during the night - Yes | 20 | 14 |
| Baseline: Woke up during the night - No | 23 | 28 |
| Week 4: Woke up during the night - Yes | 13 | 11 |
| Week 4: Woke up during the night - No | 27 | 31 |
| Baseline: Number of times woke up per night = 0 | 0 | 1 |
| Baseline: Number of times woke up per night = 1 | 12 | 6 |
| Baseline: Number of times woke up per night = 2 | 8 | 6 |
| Baseline: Number of times woke up per night = 3 | 0 | 1 |
| Baseline: Number of times woke up per night = 4 | 0 | 0 |
| Baseline: Number of times woke up per night >= 5 | 0 | 0 |
| Week 4: Number of times woke up per night = 0 | 0 | 1 |
| Week 4: Number of times woke up per night = 1 | 8 | 8 |
| Week 4: Number of times woke up per night = 2 | 5 | 1 |
| Week 4: Number of times woke up per night = 3 | 0 | 0 |
| Week 4: Number of times woke up per night = 4 | 0 | 1 |
| Week 4: Number of times woke up per night >= 5 | 0 | 0 |
| Baseline: Was the past week a typical week - Yes | 39 | 36 |
| Baseline: Was the past week a typical week - No | 4 | 6 |
| Week 4: Was the past week a typical week - Yes | 36 | 36 |
| Week 4: Was the past week a typical week - No | 4 | 6 |
| Baseline: Past week was not typical - Vacation | 2 | 2 |
| Baseline: Past week was not typical - School break | 1 | 2 |
| Baseline: Past week was not typical - Friend house | 0 | 0 |
| Baseline: Past week was not typical - ill | 0 | 0 |
| Baseline: Past week was not typical - other | 1 | 2 |
| Week 4: Past week was not typical - Vacation | 0 | 0 |
| Week 4: Past week was not typical - School break | 3 | 3 |
| Week 4: Past week was not typical - Friend house | 0 | 0 |
| Week 4: Past week was not typical - ill | 0 | 1 |
| Week 4: Past week was not typical - other | 1 | 2 |
| Baseline : Overall quality - Better than usual | 0 | 1 |
| Baseline: Overall quality - Same as usual | 6 | 7 |
| Baseline: Overall quality - Worse than usual | 2 | 1 |
| Week 4: Overall quality - Better than usual | 1 | 2 |
| Week 4: Overall quality - Same as usual | 4 | 7 |
| Week 4: Overall quality - Worse than usual | 0 | 2 |
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.
| minutes | Placebo | SHP465 |
|---|---|---|
| Baseline: Length of Time to fall asleep per night | 27.0 ± 20.25 | 27.2 ± 21.51 |
| Week 4: Length of Time to fall asleep per night | 19.3 ± 16.13 | 21.0 ± 14.35 |
| Baseline: Length of Time awake per night | 12.4 ± 8.41 | 8.0 ± 7.63 |
| Week 4: Length of Time awake per night | 8.9 ± 5.18 | 15.1 ± 17.01 |
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.
| hours | Placebo | SHP465 |
|---|---|---|
| Baseline | 8.9 ± 1.20 | 8.8 ± 1.22 |
| Week 4 | 9.1 ± 1.34 | 8.9 ± 1.16 |
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.
| Units on scale | Placebo | SHP465 |
|---|---|---|
| Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Week 4 | 42.7 ± 9.36 | 42.8 ± 9.17 |
C-SSRS was a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The number of participants with clinical significant change in suicidal ideation and suicidal behavior were reported.
| Participants | Placebo | SHP465 |
|---|---|---|
| Suicidal Ideation | 0 | 0 |
| Suicidal Behavior | 0 | 0 |
Collected over From start of study drug administration up to follow-up (Week 5). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/43 (0%) | 0/43 (0%) | 3/43 (7%) |
| SHP465 | 0/45 (0%) | 0/45 (0%) | 2/45 (4.4%) |
| Event | Placebo | SHP465 |
|---|---|---|
| HeadacheNervous system disorders | 3/43 | 2/45 |
Safety set consisted of all participants in the randomized set who took at least 1 dose of investigational product.
| Age, Continuous(Years) | Placebo | SHP465 | Total |
|---|---|---|---|
| Mean | 8.8 ± 2.03 | 8.8 ± 2.20 | 8.8 ± 2.11 |
| Sex: Female, Male(Participants) | Placebo | SHP465 | Total |
|---|---|---|---|
| Female | 14 | 18 | 32 |
| Male | 29 | 27 | 56 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | SHP465 | Total |
|---|---|---|---|
| Hispanic or Latino | 17 | 20 | 37 |
| Not Hispanic or Latino | 26 | 24 | 50 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race/Ethnicity, Customized(Participants) | Placebo | SHP465 | Total |
|---|---|---|---|
| Race — White | 28 | 30 | 58 |
| Race — Black or African American | 10 | 11 | 21 |
| Race — American Indian or Alaska Native | 1 | 0 | 1 |
| Race — Other | 4 | 4 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Dec 2017 to primary completion in Jun 2018, 5 months.
Results were first posted in Aug 2019, 1 year 2 months after primary completion.
Of 66 industry-sponsored phase 3 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's 5 months is below that.
Counting every sponsor, half of 80 studies reached it within 14 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: SHP465
Attention Deficit Disorder with Hyperactivity →