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CompletedNCT02466386Updated Mar 5, 2021Results posted

Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder

A Phase 3 interventional study of SPD489 in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire. Completed at 50 sites in United States. Open to participants aged 4 Years to 5 Years. Per ClinicalTrials.gov, last updated 2021-03-05.

Sponsored by Shire · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
113
Allocation
Non-randomized
Ages
4 Years to 5 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD).

Read the detailed description

This study is a long-term, open-label study where participants who participated in an antecedent SPD489 study (SPD489-211 [NCT02402166] or SPD489-347 [NCT03260205]) or through direct enrollment. Participants entering into this study will be classified as either a roll-over participants or a direct-enrolled participants.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder (ADHD)
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 113 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participant is male or female aged 4-5 years inclusive at the time of consent from antecedent studies SPD489-211 or SPD489-347 or at the time of consent if directly enrolled.
  2. Before completing any study-related procedures, participant's parent(s) or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the participant indicating that the participant is aware of the investigational nature of the study. The participant's parent(s) or LAR should understand that the required procedures and restrictions are being conducted in accordance with the International Council of Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (1996), any updates or revisions, and applicable federal or local regulations.
  3. Participant and parent(s)/LAR are willing and able to comply with all of the testing and requirements defined in the protocol, including oversight of morning dosing. Specifically, the parent/LAR should be available at approximately 7:00AM (+2 hours) to dispense the dose of investigational product for the duration of the study.

  4. Roll-over participant from antecedent SPD489-347 study:

    a. Participant completed the antecedent study (SPD489-347)

  5. Direct enrolled participants must meet antecedent study inclusion criteria, as listed below

    1. Participant must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) criteria for a primary diagnosis of ADHD (any subtype) based on a detailed psychiatric evaluation conducted by a sponsor-approved clinician
    2. Participant has an attention-deficit/hyperactivity disorder rating scale- IV (ADHD-RS-IV) Preschool Version total score at the Baseline Visit (Visit 0) of greater than equals to (>=) 28 for boys and >= 24 for girls.
    3. Participant has a Clinical Global Impressions - Severity of Illness (CGI-S) score >=4 at the Baseline Visit (Visit 0).
    4. Participant has a Peabody Picture Vocabulary Test, Fourth Edition standard score of >=70 at the Screening Visit (Visit -1).
    5. Participant has undergone an adequate course of non-pharmacological treatment based on investigator judgment or the participant has a severe enough condition to consider enrollment without undergoing prior non-pharmacological treatment, based on investigator judgment.
    6. Participant has, in the opinion of the investigator, participated in a structured group activity (eg, preschool, sports, Sunday school) so as to assess symptoms and impairment in a setting outside the home.
    7. Participant has lived with the same parent(s) or guardian for >=6 months.

Exclusion criteria

Exclusion Criteria:

  1. Participant was terminated from an antecedent SPD489 study for non-compliance and/or experienced a serious adverse event (SAE) or adverse event (AE) resulting in termination.
  2. Participant is required to or anticipates the need to take medications that have central nervous system effects or affect performance, such as, but not limited to, sedating antihistamines and decongestant sympathomimetics, or monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.
  3. Participant has a concurrent chronic or acute illness (such as, but not limited to, severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the participant. Similarly, the participant will be excluded if he or she has any additional condition(s) that, in the investigator's opinion, would prohibit the participant from completing the study or would not be in the best interest of the participant. The additional condition(s) would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
  4. Participant has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
  5. Participant has a known family history of sudden cardiac death or ventricular arrhythmia.
  6. Participant has a blood pressure measurement >= 95th percentile for age, sex, and height at the screening visit (Visit -1) or the baseline visit (Visit 0) or a history of moderate or severe hypertension.
  7. Participant has a known history of symptomatic cardiovascular disease, unexplained syncope, exertional chest pain, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems placing them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
  8. Participant is taking any medication that is excluded per the protocol.
  9. Participant had any clinically significant electrocardiogram (ECG) or clinical laboratory abnormalities at the Screening Visit (Visit -1) or baseline visit (Visit 0), based on investigator judgment.
  10. Participant has a history of hyperthyroidism, or current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4) at the Screening Visit (Visit-1) or Visit 0. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
  11. Participant has taken another investigational product or has taken part in a clinical study within 30 days prior to the Screening Visit (Visit -1).
  12. Participant is well-controlled on his/her current ADHD medication with acceptable tolerability.
  13. Participant has glaucoma.
  14. Participant has failed to fully respond, based on investigator judgment, to an adequate course of amphetamine therapy.

  15. Participant has a current, controlled (requiring medication or therapy) or uncontrolled, comorbid psychiatric disorder including but not limited to any of the below co-morbid Axis I disorders and Axis II disorders:

    1. post-traumatic stress disorder (PTSD) or adjustment disorder
    2. bipolar illness, psychosis, or family history of these disorders
    3. pervasive developmental disorder
    4. obsessive-compulsive disorder (OCD)
    5. psychosis/schizophrenia
    6. participant has a serious tic disorder, or a family history of Tourette's disorder
    7. participant is currently considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Participants with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator
    8. a history of physical, sexual, or emotional abuse
    9. any other disorder or agitated state that in the opinion of the investigator, contraindicates SPD489 or lisdexamfetamine dimesylate treatment or confound efficacy or safety assessments.
  16. Participant has initiated behavioral therapy within 1 month of the baseline visit (Visit 0). Participant may not initiate behavioral therapy during the study.
  17. Participant has a height \<=5th percentile for age and sex at the screening visit (Visit -1).
  18. Participant has a weight \<=5th percentile for age and sex at the screening visit (Visit -1).
  19. Participant lives with anyone who currently abuses stimulants or cocaine.
  20. Participant has a history of seizures (other than infantile febrile seizures).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
113 participants (actual)

Study arms

  • Experimental
    SPD489

    Participants will receive 5 milligrams (mg) of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached within 52 weeks.

    Drug: SPD489

Interventions

  • DrugSPD489

    Participants will receive 5 mg of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached.

    Also known as: Lisdexamfetamine dimesylate

06

What researchers measure

Primary outcomes

  1. 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 (Week 53)

  2. Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)

    Sleep patterns included sleep diary data and children's sleep habits questionnaire (CSHQ), which was parent report questionnaire designed to screen for the most common sleep problems in children, and consisted of 33 items for scoring and several extra items intended to provide administrators with other potentially useful information about respondents. The instrument evaluates the child's sleep based on behavior within 8 different sub scales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, and daytime sleepiness: 8 to 24.

    Time frame: Week 52/ET

  3. Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)

    12-lead ECG was evaluated and recorded. ECG variables included heart rate, PR interval, QRS interval, QT interval, and corrected QT interval (QTc). The QTc was calculated using both Bazett (QTcB=QT/\[RR\]1/2) and Fridericia (QTcF=QT/\[RR\]1/3) corrections. Here, \> = represents "greater than or equal to", \< represents "lesser than" and \> represents "greater than".

    Time frame: Week 52/ET

  4. Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS) at Week 52/ Early Termination (ET)

    C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported.

    Time frame: Week 52/ET

  5. Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values at Week 52/ Early Termination (ET)

    Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported.

    Time frame: Week 52/ET

  6. Number of Participants With Potentially Clinically Significant Changes in Vital Signs at Week 52/ Early Termination (ET)

    Vital sign assessments included blood pressure, pulse and respiratory rate. Number of participants with potentially clinically significant changes in vital signs were reported.

    Time frame: Week 52/ET

  7. Number of Participants With Shift From Baseline in Body Mass Index (BMI) Percentiles at Week 52/Early Termination (ET)

    BMI was derived from height and weight. BMI was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI \< 5th percentile); Healthy weight (BMI 5th percentile up to \< 85th percentile); Overweight (BMI 85th percentile \< 95th percentile); Obese (BMI \>= 95th percentile). Number of participants with shift from baseline in BMI percentile categories at Week 52/ET was reported.

    Time frame: Week 52/ET

Secondary outcomes

  1. Clinical Global Impressions Global Improvement (CGI-I) at Week 52/ Early Termination (ET)

    CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

    Time frame: Week 52/ET

  2. Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 52/ Early Termination (ET)

    ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17).

    Time frame: Week 52/ET

07

Results

Posted Mar 5, 2021

Participant flow

This study was conducted at 32 sites in United States of America from 21 August 2015 (first participant first visit) to 03 January 2020 (last participant last visit).

Participant flow — Overall Study
MilestoneSPD489
Started113
Completed69
Not completed44
Withdrew: Adverse event5
Withdrew: Protocol violation2
Withdrew: Withdrawal by subject14
Withdrew: Lost to follow-up5
Withdrew: Lack of efficacy8
Withdrew: Other10

Outcome measures

PrimaryNumber 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 (Week 53)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
ParticipantsSPD489
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)86
PrimaryChange From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)

Sleep patterns included sleep diary data and children's sleep habits questionnaire (CSHQ), which was parent report questionnaire designed to screen for the most common sleep problems in children, and consisted of 33 items for scoring and several extra items intended to provide administrators with other potentially useful information about respondents. The instrument evaluates the child's sleep based on behavior within 8 different sub scales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, and daytime sleepiness: 8 to 24.

Time frame:
Week 52/ET
Reported as:
Mean · Score on scale
Change From Baseline in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire (CSHQ) at Week 52/ Early Termination (ET)
Score on scaleSPD489
Bedtime Resistance: Week 52/ET8.9 ± 3.04
Sleep-onset Delay: Week 52/ET1.6 ± 0.67
Sleep Duration: Week 52/ET3.8 ± 1.26
Sleep Anxiety: Week 52/ET5.5 ± 2.09
Night Wakings: Week 52/ET4.2 ± 1.59
Parasomnias: Week 52/ET8.6 ± 1.54
Sleep-disordered Breathing: Week 52/ET3.4 ± 0.74
Daytime Sleepiness: Week 52/ET10.1 ± 3.78
PrimaryNumber of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)

12-lead ECG was evaluated and recorded. ECG variables included heart rate, PR interval, QRS interval, QT interval, and corrected QT interval (QTc). The QTc was calculated using both Bazett (QTcB=QT/\[RR\]1/2) and Fridericia (QTcF=QT/\[RR\]1/3) corrections. Here, \> = represents "greater than or equal to", \< represents "lesser than" and \> represents "greater than".

Time frame:
Week 52/ET
Reported as:
Count of participants · Participants
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters at Week 52/ Early Termination (ET)
ParticipantsSPD489
Heart Rate (< 55 Beats per minute)0
Heart Rate (> 130 Beats per minute)0
PR Interval (>= 200 millisecond [msec])0
QRS Interval (>= 90 msec)3
QT Interval (> = 440 msec)0
QTcB Interval (> = 440 msec and < 480 msec)5
QTcB Interval (>= 480 msec and < 500 msec)0
QTcB Interval (>= 500 msec)0
QTcF Interval (> = 440 msec and < 480 msec)0
QTcF Interval (>= 480 msec and < 500 msec)0
QTcF Interval (>= 500 msec)0
ECG Interpretation0
ECG Abnormality - Rhythm0
PrimaryNumber of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS) at Week 52/ Early Termination (ET)

C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported.

Time frame:
Week 52/ET
Reported as:
Count of participants · Participants
Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS) at Week 52/ Early Termination (ET)
ParticipantsSPD489
Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS) at Week 52/ Early Termination (ET)0
PrimaryNumber of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values at Week 52/ Early Termination (ET)

Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported.

Time frame:
Week 52/ET
Reported as:
Count of participants · Participants
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values at Week 52/ Early Termination (ET)
ParticipantsSPD489
Hematology: Eosinophils/Leukocytes: Greater than (>)10%12
Hematology: Hematocrit: Less than (<) 0.32
Hematology: Leukocytes: <3 × 10^9/Liter (L)1
Hematology: Leukocytes: >16 × 10^9/L1
Hematology: Lymphocytes/leukocytes: >70%1
Hematology: Neutrophils: <1 × 10^9/L1
Hematology: Neutrophils/leukocytes: <30%15
Hematology: Platelets: <75 × 10^9/L1
Biochemistry and Endocrinology: Glucose: <3.05 Millimole per liter (mmol/L)2
Biochemistry and Endocrinology: Glucose: >8.88 mmol/L2
Biochemistry and Endocrinology: Potassium: >5.5 mmol/L1
Biochemistry and Endocrinology: Protein: >90 gram per liter (g/L)1
Biochemistry and Endocrinology: Thyrotropin: < Lower limit of normal (LLN)7
Urinalysis: Ketones: Positive value (excluding trace)15
Urinalysis: Occult blood: Positive value (excluding trace)2
Urinalysis: Protein: Positive value (excluding trace)30
PrimaryNumber of Participants With Potentially Clinically Significant Changes in Vital Signs at Week 52/ Early Termination (ET)

Vital sign assessments included blood pressure, pulse and respiratory rate. Number of participants with potentially clinically significant changes in vital signs were reported.

Time frame:
Week 52/ET
Reported as:
Count of participants · Participants
Number of Participants With Potentially Clinically Significant Changes in Vital Signs at Week 52/ Early Termination (ET)
ParticipantsSPD489
Number of Participants With Potentially Clinically Significant Changes in Vital Signs at Week 52/ Early Termination (ET)0
SecondaryClinical Global Impressions Global Improvement (CGI-I) at Week 52/ Early Termination (ET)

CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

Time frame:
Week 52/ET
Reported as:
Mean · Score on a scale
Clinical Global Impressions Global Improvement (CGI-I) at Week 52/ Early Termination (ET)
Score on a scaleSPD489
Clinical Global Impressions Global Improvement (CGI-I) at Week 52/ Early Termination (ET)2.0 ± 0.91
SecondaryChange From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 52/ Early Termination (ET)

ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17).

Time frame:
Week 52/ET
Reported as:
Mean · Score on a scale
Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 52/ Early Termination (ET)
Score on a scaleSPD489
Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 52/ Early Termination (ET)-24.2 ± 13.34
PrimaryNumber of Participants With Shift From Baseline in Body Mass Index (BMI) Percentiles at Week 52/Early Termination (ET)

BMI was derived from height and weight. BMI was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI \< 5th percentile); Healthy weight (BMI 5th percentile up to \< 85th percentile); Overweight (BMI 85th percentile \< 95th percentile); Obese (BMI \>= 95th percentile). Number of participants with shift from baseline in BMI percentile categories at Week 52/ET was reported.

Time frame:
Week 52/ET
Reported as:
Count of participants · Participants
Number of Participants With Shift From Baseline in Body Mass Index (BMI) Percentiles at Week 52/Early Termination (ET)
ParticipantsSPD489
Underweight: Week 52/ET8
Healthy Weight: Week 52/ET78
Overweight: Week 52/ET12
Obese: Week 52/ET3

Adverse events

Collected over From start of study drug administration up to follow-up (Week 53). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Total0/113 (0%)0/113 (0%)57/113 (50.4%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventTotal
Decreased appetiteMetabolism and nutrition disorders18/113
PyrexiaGeneral disorders11/113
InfluenzaInfections and infestations10/113
Pharyngitis streptococcalInfections and infestations9/113
NasopharyngitisInfections and infestations8/113
Upper respiratory tract infectionInfections and infestations8/113
Weight decreasedInvestigations7/113
Affect labilityPsychiatric disorders7/113
CoughRespiratory, thoracic and mediastinal disorders7/113
VomitingGastrointestinal disorders6/113

Baseline characteristics

Safety analysis set consisted of all participants who took at least 1 dose of investigational product.

Age, Continuous
Age, Continuous(Years)SPD489
Mean4.8 ± 0.63
Sex: Female, Male
Sex: Female, Male(Participants)SPD489
Female33
Male80
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SPD489
Hispanic or Latino12
Not Hispanic or Latino101
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SPD489
American Indian or Alaska Native1
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American42
White63
More than one race2
Unknown or Not Reported5
08

Study locations

50 sites
  • Harmonex, Inc
    Dothan, Alabama 36303, United States
  • Preferred Research Partners, Inc.
    Little Rock, Arkansas 72211, United States
  • Sun Valley Research Center
    Imperial, California 92251, United States
  • Alliance for Wellness d/b/a Alliance for Research
    Long Beach, California 90807, United States
  • AVIDA
    Newport Beach, California 92660, United States
  • Asclepes Research
    Panorama City, California 91402, United States
  • Psychiatric Centers at San Diego
    San Diego, California 92108, United States
  • University of California
    San Francisco, California 94143, United States
  • Elite Clinical Trials, Inc
    Wildomar, California 92595, United States
  • Avail Clinical Research, LLC
    DeLand, Florida 32720, United States
  • Sarkis Clinical Trials
    Gainesville, Florida 32607, United States
  • Medical Research Group of Central Florida
    Orange City, Florida 32763, United States
  • Clinical Neuroscience Solutions
    Orlando, Florida 32801, United States
  • APG Research, LLC
    Orlando, Florida 32803, United States
  • University of South Florida
    Saint Petersburg, Florida 33701, United States
  • University of South Florida Department Of Psychiatry
    Tampa, Florida 33613, United States
  • iResearch Atlanta LLC
    Decatur, Georgia 30030, United States
  • Lake Charles Clinical Trials
    Lake Charles, Louisiana 70629, United States
  • Kennedy Krieger Institute
    Baltimore, Maryland 21205, United States
  • Rochester Center for Behavioral Medicine
    Rochester Hills, Michigan 48306, United States
  • Clinical Neurophysiology Services
    Sterling Heights, Michigan 48314, United States
  • Washington University
    Saint Louis, Missouri 63110, United States
  • Premier Psychiatric Reseach Institute, LLC
    Lincoln, Nebraska 68526, United States
  • Center For Psychiatry and Behavioral Medicine In
    Las Vegas, Nevada 89128, United States
  • Jersey Shore University Medical Center (JSUMC)
    Neptune, New Jersey 7753, United States
  • Manhattan Behavioral Medicine
    New York, New York 10036, United States
  • University of Rochester
    Rochester, New York 14627, United States
  • Duke Child and Family Center
    Durham, North Carolina 27705, United States
  • University of Cincinnati
    Cincinnati, Ohio 45219, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • Pediatric Associates of Fairfield, Inc.
    Fairfield, Ohio 45014, United States
  • IPS Research Company
    Oklahoma City, Oklahoma 73103, United States
  • Oklahoma Clinical Research Center
    Oklahoma City, Oklahoma 73112, United States
  • Paradigm Research Professionals
    Oklahoma City, Oklahoma 73118, United States
  • Cutting Edge Research Group
    Oklahoma City, Oklahoma 73120, United States
  • Cyn3rgy Research Center
    Gresham, Oregon 97030, United States
  • Rainbow Research Inc
    Barnwell, South Carolina 29812, United States
  • Carolina Clinical Trials, Inc.
    Charleston, South Carolina 29407, United States
  • Coastal Carolina Research
    Mount Pleasant, South Carolina 29464, United States
  • Clinical Neuroscience Solutions, Inc
    Memphis, Tennessee 38119, United States
  • BioBehavioral Research of Austin
    Austin, Texas 78759, United States
  • Bayou City Research Limited
    Houston, Texas 77007, United States
  • BI Research Center
    Houston, Texas 77084, United States
  • Red Oak Psychiatry Associates
    Houston, Texas 77090, United States
  • Road Runner Research
    San Antonio, Texas 78249, United States
  • Family Psychiatry of the Woodlands
    The Woodlands, Texas 77381, United States
  • Ericksen Research and Development
    Clinton, Utah 84015, United States
  • Clinical Research Partners, LLC
    Petersburg, Virginia 23805, United States
  • Northwest Clinical Research Center
    Bellevue, Washington 98007, United States
  • Seattle Childrens Hospital
    Seattle, Washington 98105, United States
09

References and documents

Publications

  • Childress AC, Lloyd E, Johnson SA Jr, Gunawardhana L, Arnold V. A Long-Term, Open-Label Safety and Tolerability Study of Lisdexamfetamine Dimesylate in Children Aged 4-5 Years with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2022 Mar;32(2):98-106. doi: 10.1089/cap.2021.0138. Epub 2022 Mar 8. PubMed 35230142 ↗

Study documents

  • Study protocol · Oct 21, 2014
  • Study protocol · Jun 28, 2017
  • Study protocol · Oct 20, 2017
  • Statistical analysis plan · Jul 17, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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, Sap, Icf, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02466386
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Jun 9, 2015
Start date
Aug 21, 2015
Primary completion
Jan 3, 2020
Completion
Jan 3, 2020
Results posted
Mar 5, 2021
Last update
Mar 5, 2021

Study contacts

Shire Physician
study director · Shire

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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