A Phase 3 interventional study of SHP465 in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire. Terminated at 48 sites in United States. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-06-03.
Sponsored by Shire (part of Takeda) · Phase 3, Interventional, and Treatment
The purpose of the study is to evaluate the long-term safety and tolerability of SHP465 at 6.25 milligram (mg) in children aged 4 to 12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
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 141 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.
Group A participants who have been rolled-over from antecedent SHP465 studies and Group B participants who will be newly enrolled into the study will receive SHP465 capsule 6.25 mg orally once daily for 360 days.
Drug: SHP465
SHP465 capsule will be administered in a dose of 6.25 mg orally once daily for 360 days.
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 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.
Time frame: From start of study drug administration up to follow-up (approximately up to 367 days)
Change From Baseline in Pulse Rate at Final On-Treatment Assessment (FoTA)
Change from baseline in pulse rate at FoTA was reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Time frame: Baseline, FoTA (up to 330 days)
Change From Baseline in Blood Pressure at Final On-Treatment Assessment (FoTA)
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at FoTA was reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Time frame: Baseline, FoTA (up to 330 days)
Change From Baseline in Height at Final On-Treatment Assessment (FoTA)
Height was measured in centimeters (cm) without shoes and with light clothing using a stadiometer. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Time frame: Baseline, FoTA (up to 330 days)
Change From Baseline in Weight at Final On-Treatment Assessment (FoTA)
Weight was measured in kilograms (kg) without shoes and with light clothing using a calibrated scale. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Time frame: Baseline, FoTA (up to 330 days)
Change From Baseline in Hematology Parameters at Early Termination/Day 360
Change from baseline in hematology parameter basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils band form, segmented neutrophils, neutrophils/total cells and platelets were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Leukocytes at Early Termination/Day 360
Change from baseline in hematology leukocytes parameter: basophils, eosinophils, lymphocytes, monocytes and neutrophil were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Erythrocytes at Early Termination/Day 360
Change from baseline in hematology parameter erythrocytes were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin Concentration at Early Termination/Day 360
Change from baseline in hematology parameter erythrocytes mean corpuscular hemoglobin concentration were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Early Termination/Day 360
Change from baseline in hematology parameter erythrocytes mean corpuscular hemoglobin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Hematocrit at Early Termination/Day 360
Change from baseline in hematology parameter hematocrit were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Hemoglobin at Early Termination/Day 360
Change from baseline in hematology parameter hemoglobin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Hematology Parameters (Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume) at Early Termination/ Day 360
Change from baseline in hematology parameter erythrocytes mean corpuscular volume and mean platelet volume were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Chemistry Parameters at Early Termination/Day 360
Change from baseline in chemistry parameter alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, and lactate dehydrogenase were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Early Termination/Day 360
Change from baseline in chemistry parameters albumin and protein were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Chemistry Parameters (Blood Urea Nitrogen, Cholesterol, Glucose, Phosphate, Potassium, Sodium and Urate) at Early Termination/Day 360
Change from baseline in chemistry parameters blood urea nitrogen, cholesterol, glucose, phosphate, potassium, sodium and urate were studies. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Chemistry Parameters (Bilirubin and Creatinine) at Early Termination/Day 360
Change from baseline in chemistry parameters bilirubin and creatinine were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Thyrotropin at Early Termination/ Day 360
Change from baseline in thyrotropin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Thyroxine,Free at Early Termination/Day 360
Change from baseline in thyroxine,free were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Urinalysis (Specific Gravity) at Early Termination/Day 360
Change from baseline in urine specific gravity were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Urobilinogen at Early Termination/Day 360
Change from baseline in urobilinogen were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early termination/Day 360
Change From Baseline in Urine Potential of Hydrogen (pH) at Early Termination/Day 360
Change from baseline in urine pH were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: Baseline, Early Termination/Day 360
Change From Baseline in Heart Rate at Final On-Treatment Assessment (FoTA)
Heart rate was measured by Electrocardiogram (ECG). ECG was performed using the central ECG provider's equipment and was send to the central ECG provider electronically. Change from baseline in heart rate at FoTA were reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the average of all valid ECG measurements as the last assessment obtained before the first dose of investigational product.
Time frame: Baseline, FoTA (up to 330 days)
Change From Baseline in Electrocardiogram Parameters at Final On-Treatment Assessment (FoTA)
ECG was performed using the central ECG provider's equipment and was sent to the central ECG provider electronically to measure PR, RR, QRS , QT, QTcB and QTcF intervals. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date).Group A baseline was the baseline of the antecedent studies. Group B baseline was the average of all valid ECG measurements as the last assessment obtained before the first dose of investigational product.
Time frame: Baseline, FoTA (up to 330 days)
Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects 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. The assessment was done by the nature of the responses, not by a numbered scale. 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. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time frame: FoTA (up to 330 days)
Length of Time Awake Per Night and Length of Time to Fall Asleep Per Night Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects 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. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product. Length of time awake per night and length of time to fall asleep per night was assessed at FoTA.
Time frame: FoTA (up to 330 days)
Length of Time Sleeping Per Night Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects 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. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product. Length of time sleeping per night was assessed at FoTA.
Time frame: FoTA (up to 330 days)
Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Final On-Treatment Assessment (FoTA)
CSHQ was a tool 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 8 different subscales: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. 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: FoTA (up to 330 days)
Number of Participants With a Positive Response in Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 330
C-SSRS is 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 postive response in suicidal ideation and suicidal behavior were reported.
Time frame: Day 330
Change From Baseline in Clinician-administered Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Final On-Treatment Assessment (FoTA)
Clinician administered ADHD-RS-5, child, home version total score were analyzed. ADHD-RS-5 consists 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 is 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 may be grouped into 2 subscales: hyperactivity/impulsivity (9 items) and inattentiveness (9 items). Higher total scores indicated higher impairment and lower scores indicated no impairment. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date).
Time frame: Baseline, FoTA (up to 330 days)
Clinical Global Impression of Improvement (CGI-I) at Final On-Treatment Assessment (FoTA)
CGI-I scale was performed to rate the improvement of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date).
Time frame: FoTA (up to 330 days)
The study was conducted at 33 centers in the United States between 02 January 2018 (first participant first visit) and 19 January 2019 (last participant last visit).
| Milestone | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Started | 64 | 77 |
| Completed | 0 | 0 |
| Not completed | 64 | 77 |
| Withdrew: Adverse event | 2 | 3 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Withdrawal by subject | 10 | 6 |
| Withdrew: Lost to follow-up | 4 | 9 |
| Withdrew: Lack of efficacy | 8 | 14 |
| Withdrew: Study terminated by sponsor | 38 | 43 |
| Withdrew: Other (not received treatment) | 1 | 0 |
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.
| Participants | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 29 | 38 |
Change from baseline in pulse rate at FoTA was reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
| beats per minute | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Pulse Rate at Final On-Treatment Assessment (FoTA) | 1.5 ± 9.82 | 0.1 ± 10.31 |
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at FoTA was reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
| Millimeters of mercury | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| SBP: Change at FoTA | 0.6 ± 7.17 | 0.6 ± 7.36 |
| DBP: Change at FoTA | 2.3 ± 7.76 | 1.7 ± 6.03 |
Height was measured in centimeters (cm) without shoes and with light clothing using a stadiometer. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
| centimeter | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Height at Final On-Treatment Assessment (FoTA) | 3.7 ± 4.60 | 2.9 ± 2.49 |
Weight was measured in kilograms (kg) without shoes and with light clothing using a calibrated scale. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
| kilograms | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Weight at Final On-Treatment Assessment (FoTA) | 1.4 ± 2.93 | 1.1 ± 2.41 |
Change from baseline in hematology parameter basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils band form, segmented neutrophils, neutrophils/total cells and platelets were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| 10^9 cells per liter | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Basophils | -0.01 ± 0.040 | 0.01 ± 0.051 |
| Eosinophils | 0.02 ± 0.389 | 0.04 ± 0.240 |
| Leukocytes | -0.25 ± 1.519 | -0.09 ± 2.107 |
| Lymphocytes | 0.14 ± 0.948 | -0.12 ± 0.685 |
| Monocytes | -0.12 ± 0.282 | 0.01 ± 0.217 |
| Neutrophils Band Form | 0.00 ± 0.00 | 0.00 ± 0.049 |
| Segmented Neutrophils | -0.40 ± 1.296 | -0.02 ± 2.139 |
| Neutrophils/Total Cells | -0.32 ± 1.349 | 0.00 ± 1.915 |
| Platelets | 8.0 ± 46.76 | 4.6 ± 60.19 |
Change from baseline in hematology leukocytes parameter: basophils, eosinophils, lymphocytes, monocytes and neutrophil were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| percentage of leukocytes | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Basophils/Leukocytes | -0.17 ± 0.631 | 0.04 ± 0.589 |
| Eosinophils/Leukocytes | 0.38 ± 4.288 | 0.30 ± 3.222 |
| Lymphocytes/Leukocytes | 4.42 ± 12.140 | -0.97 ± 11.517 |
| Monocytes/Leukocytes | -1.02 ± 3.982 | 0.52 ± 2.650 |
| Neutrophils Band Form/Leukocytes | 0.0 ± 0.00 | 0.0 ± 0.62 |
| Neutrophils, Segmented/Leukocytes | -3.8 ± 12.39 | -0.6 ± 13.15 |
| Neutrophils/Leukocytes | -3.62 ± 13.359 | 0.35 ± 11.756 |
Change from baseline in hematology parameter erythrocytes were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| 10^12 cells per liter | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Erythrocytes at Early Termination/Day 360 | 0.017 ± 0.3368 | -0.007 ± 0.2889 |
Change from baseline in hematology parameter erythrocytes mean corpuscular hemoglobin concentration were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| gram per deciliter | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin Concentration at Early Termination/Day 360 | -0.09 ± 0.664 | -0.16 ± 1.018 |
Change from baseline in hematology parameter erythrocytes mean corpuscular hemoglobin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| picogram | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Early Termination/Day 360 | 0.42 ± 0.642 | 0.38 ± 1.259 |
Change from baseline in hematology parameter hematocrit were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| percentage of hematocrit | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Hematocrit at Early Termination/Day 360 | 0.86 ± 2.784 | 0.59 ± 2.901 |
Change from baseline in hematology parameter hemoglobin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| gram per liter | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Hemoglobin at Early Termination/Day 360 | 2.5 ± 8.68 | 1.5 ± 9.82 |
Change from baseline in hematology parameter erythrocytes mean corpuscular volume and mean platelet volume were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| femtoliters | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Erythrocytes Mean Corpuscular Volume | 1.48 ± 1.438 | 1.46 ± 2.565 |
| Mean Platelet Volume | -0.1 ± 0.77 | 0.2 ± 0.96 |
Change from baseline in chemistry parameter alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, and lactate dehydrogenase were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| Unit per liter | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Alanine Aminotransferase | -2.3 ± 4.18 | 9.6 ± 52.75 |
| Alkaline Phosphatase | -18.2 ± 62.28 | -32.6 ± 68.15 |
| Aspartate Aminotransferase | -1.9 ± 5.27 | 21.4 ± 129.48 |
| Gamma Glutamyl Transferase | -0.4 ± 2.20 | 1.3 ± 5.06 |
| Lactate Dehydrogenase | -9.0 ± 24.24 | 26.2 ± 185.52 |
Change from baseline in chemistry parameters albumin and protein were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| gram per liter | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Albumin | -0.2 ± 2.82 | -0.1 ± 2.45 |
| Protein | 0.7 ± 4.27 | 1.0 ± 3.55 |
Change from baseline in chemistry parameters blood urea nitrogen, cholesterol, glucose, phosphate, potassium, sodium and urate were studies. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| millimoles per liter | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Blood Urea Nitrogen | -0.235 ± 1.0664 | -0.036 ± 1.4248 |
| Calcium | 0.035 ± 0.1101 | 0.004 ± 0.0977 |
| Cholesterol | -0.082 ± 0.4592 | -0.295 ± 0.8294 |
| Glucose | -0.183 ± 0.9841 | 0.138 ± 0.9205 |
| Phosphate | -0.045 ± 0.1940 | -0.153 ± 0.2056 |
| Potassium | -0.02 ± 0.569 | -0.01 ± 0.367 |
| Sodium | 0.8 ± 2.57 | 0.3 ± 2.48 |
| Urate | -0.0073 ± 0.04488 | 0.0142 ± 0.07180 |
Change from baseline in chemistry parameters bilirubin and creatinine were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| micromoles per liter | Group A (Antecedent Study) | Group B (Direct Enrollment) |
|---|---|---|
| Bilirubin | 0.90 ± 3.644 | -0.14 ± 2.994 |
| Creatinine | 3.3 ± 8.20 | 6.7 ± 17.15 |
Change from baseline in thyrotropin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| milli-international units per litre | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Thyrotropin at Early Termination/ Day 360 | 0.2576 ± 0.98862 | 0.2392 ± 0.90169 |
Change from baseline in thyroxine,free were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| picomole per liter | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Thyroxine,Free at Early Termination/Day 360 | 0.61 ± 1.851 | -0.46 ± 2.632 |
Change from baseline in urine specific gravity were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| Ratio | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Urinalysis (Specific Gravity) at Early Termination/Day 360 | 0.0029 ± 0.00762 | 0.0010 ± 0.00923 |
Change from baseline in urobilinogen were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| milligrams per deciliter | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Urobilinogen at Early Termination/Day 360 | 0.09 ± 0.393 | 0.05 ± 0.309 |
Change from baseline in urine pH were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| pH | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Urine Potential of Hydrogen (pH) at Early Termination/Day 360 | 0.1 ± 0.83 | 0.1 ± 1.07 |
Heart rate was measured by Electrocardiogram (ECG). ECG was performed using the central ECG provider's equipment and was send to the central ECG provider electronically. Change from baseline in heart rate at FoTA were reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the average of all valid ECG measurements as the last assessment obtained before the first dose of investigational product.
| beats per minute | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Heart Rate at Final On-Treatment Assessment (FoTA) | 1.78 ± 7.618 | -0.12 ± 10.973 |
ECG was performed using the central ECG provider's equipment and was sent to the central ECG provider electronically to measure PR, RR, QRS , QT, QTcB and QTcF intervals. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date).Group A baseline was the baseline of the antecedent studies. Group B baseline was the average of all valid ECG measurements as the last assessment obtained before the first dose of investigational product.
| milliseconds | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| FoTA: PR Interval | -1.77 ± 10.129 | 0.14 ± 8.539 |
| FoTA: RR Interval | -18.05 ± 71.382 | -1.77 ± 88.658 |
| FoTA: QRS Interval | 0.93 ± 4.419 | 1.62 ± 5.688 |
| FoTA: QT Interval | -4.74 ± 17.826 | -1.49 ± 18.616 |
| FoTA: QTcB Interval | -0.52 ± 14.145 | -1.39 ± 14.796 |
| FoTA: QTcF Interval | -1.97 ± 13.126 | -1.37 ± 11.808 |
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects 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. The assessment was done by the nature of the responses, not by a numbered scale. 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. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
| Participants | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| FoTA: Woke up during the night - Yes | 17 | 13 |
| FoTA: Woke up during the night - No | 46 | 64 |
| FoTA: Number of times woke up per night = 0 | 0 | 2 |
| FoTA: Number of times woke up per night = 1 | 12 | 10 |
| FoTA: Number of times woke up per night = 2 | 4 | 2 |
| FoTA: Number of times woke up per night = 3 | 1 | 0 |
| FoTA: Number of times woke up per night = 4 | 0 | 0 |
| FoTA: Number of times woke up per night >= 5 | 0 | 0 |
| FoTA: Overall quality of sleep - Very Poor | 0 | 0 |
| FoTA: Overall quality of sleep - Poor | 6 | 1 |
| FoTA: Overall quality of sleep - Average | 23 | 20 |
| FoTA: Overall quality of sleep - Good | 24 | 29 |
| FoTA: Overall quality of sleep - Very Good | 10 | 27 |
| FoTA: Past week a typical week - Yes | 48 | 66 |
| FoTA: Past week a typical week - No | 15 | 11 |
| FoTA: Past week was not typical - Vacation | 4 | 1 |
| FoTA: Past week was not typical - School break | 7 | 7 |
| FoTA: Past week was not typical - Friend house | 0 | 0 |
| FoTA: Past week was not typical - ill | 0 | 2 |
| FoTA: Past week was not typical - other | 4 | 1 |
| FoTA: Overall quality - Better than usual | 1 | 0 |
| FoTA: Overall quality - Same as usual | 13 | 8 |
| FoTA: Overall quality - Worse than usual | 5 | 4 |
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects 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. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product. Length of time awake per night and length of time to fall asleep per night was assessed at FoTA.
| minutes | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Length of Time to Fall Asleep per Night | 20.2 ± 17.12 | 22.3 ± 24.74 |
| Length of Time Awake per Night | 8.8 ± 4.14 | 14.4 ± 23.10 |
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects 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. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product. Length of time sleeping per night was assessed at FoTA.
| hours | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Length of Time Sleeping Per Night Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA) | 9.1 ± 1.40 | 9.6 ± 1.21 |
CSHQ was a tool 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 8 different subscales: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. 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 | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Final On-Treatment Assessment (FoTA) | 42.2 ± 8.44 | 39.3 ± 5.85 |
C-SSRS is 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 postive response in suicidal ideation and suicidal behavior were reported.
| Participants | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Suicidal Ideation | 0 | 0 |
| Suicidal Behavior | 0 | 0 |
Clinician administered ADHD-RS-5, child, home version total score were analyzed. ADHD-RS-5 consists 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 is 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 may be grouped into 2 subscales: hyperactivity/impulsivity (9 items) and inattentiveness (9 items). Higher total scores indicated higher impairment and lower scores indicated no impairment. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date).
| Score on a scale | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Change From Baseline in Clinician-administered Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Final On-Treatment Assessment (FoTA) | -19.2 ± 1.88 | -19.3 ± 1.69 |
CGI-I scale was performed to rate the improvement of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date).
| Score on a scale | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| Clinical Global Impression of Improvement (CGI-I) at Final On-Treatment Assessment (FoTA) | 2.7 ± 0.16 | 2.9 ± 0.15 |
Collected over From start of study drug administration up to follow-up (approximately up to 367 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A (Antecedent Studies) | 0/63 (0%) | 0/63 (0%) | 12/63 (19%) |
| Group B (Direct Enrollment) | 0/77 (0%) | 1/77 (1.3%) | 20/77 (26%) |
| Event | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| RhabdomyolysisMusculoskeletal and connective tissue disorders | 0/63 | 1/77 |
| Event | Group A (Antecedent Studies) | Group B (Direct Enrollment) |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/63 | 7/77 |
| HeadacheNervous system disorders | 5/63 | 3/77 |
| Weight decreasedInvestigations | 3/63 | 6/77 |
| Decreased appetiteMetabolism and nutrition disorders | 1/63 | 6/77 |
| VomitingGastrointestinal disorders | 0/63 | 5/77 |
| IrritabilityPsychiatric disorders | 4/63 | 1/77 |
Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study.
| Age, Continuous(years) | Group A (Antecedent Studies) | Group B (Direct Enrollment) | Total |
|---|---|---|---|
| Mean | 7.5 ± 2.61 | 6.1 ± 2.33 | 6.8 ± 2.56 |
| Sex: Female, Male(Participants) | Group A (Antecedent Studies) | Group B (Direct Enrollment) | Total |
|---|---|---|---|
| Female | 22 | 28 | 50 |
| Male | 41 | 49 | 90 |
| Ethnicity (NIH/OMB)(Participants) | Group A (Antecedent Studies) | Group B (Direct Enrollment) | Total |
|---|---|---|---|
| Hispanic or Latino | 16 | 26 | 42 |
| Not Hispanic or Latino | 46 | 51 | 97 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Group A (Antecedent Studies) | Group B (Direct Enrollment) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 19 | 17 | 36 |
| White | 37 | 57 | 94 |
| More than one race | 6 | 2 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
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 Jan 2018 to primary completion in Jan 2019, 12 months.
Results were first posted in Feb 2020, 1 year after primary completion.
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Studies of the drug tested here: SHP465
Attention Deficit Disorder with Hyperactivity →