A Phase 3 interventional study of Placebo and SPD489 (Lisdexamfetamine dimesylate) in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire. Completed at 48 sites in United States. Open to participants aged 4 Years to 5 Years. Per ClinicalTrials.gov, last updated 2021-06-08.
Sponsored by Shire · Phase 3, Interventional, and Treatment
The purpose of this study is to determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old diagnosed with ADHD.
Exclusion Criteria:
Participant has a current, controlled (requiring medication or therapy) or uncontrolled, co-morbid psychiatric disorder including but not limited to any of the below co-morbid Axis I disorders and Axis II disorders:
i. post-traumatic stress disorder or adjustment disorder ii. bipolar illness, psychosis, or a family history of these disorders iii. pervasive developmental disorder iv. obsessive-compulsive disorder (OCD) v. psychosis/schizophrenia vi. a serious tic disorder, or a family history of Tourette's disorder vii. 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.
viii. a history of physical, sexual, or emotional abuse ix. 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.
Participant will receive placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.
Drug: Placebo
Participants will be randomized to receive SPD489 capsule in a 5:5:5:5:6 ratio to SPD489 5, 10, 20, 30 milligram (mg) orally once daily for 6 weeks. Dosing will begin with the lowest strength of SPD489 (5 mg), and will be titrated until the randomly assigned fixed-dose is reached.
Drug: SPD489 (Lisdexamfetamine dimesylate) · Drug: SPD489
Placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.
SPD489 capsule in a 5:5:5:5:6 ratio to 5, 10, 20, 30 mg orally once daily for 6 weeks.
SPD489
Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6
ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Full analysis set (FAS) consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.
Time frame: Baseline, Week 6
Clinical Global Impressions Global Improvement (CGI-I) at Week 6
CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. FAS consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.
Time frame: Week 6
Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6
Dose response relationship was evaluated by using the ADHD-RS Preschool Version Total Score. ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Dose response analysis set consisted of all participants in the safety analysis set who had at least 1 valid primary efficacy measurement on the randomized target dose level of the investigational product.
Time frame: Baseline, Week 6
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 investigational product (IP) and that does not necessarily had a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of IP and no later than 3 days following the last dose of IP.
Time frame: From start of study drug administration up to follow-up (Week 7)
Number of Participants With Potentially Clinically Significant Changes in Vital Signs
Vital sign assessments included blood pressure (systolic and diastolic), average pulse rate. Number of participants with potentially clinically significant changes in vital signs were reported. mmHg represents millimetre of mercury in the outcome measure data.
Time frame: Week 6
Change From Baseline in Height at Week 6
Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor.
Time frame: Baseline, Week 6
Change From Baseline in Body Weight at Week 6
Body weight was measured in percentile without shoes. Body weight percentile was normalized by sex and age using the Centers for Disease Control and Prevention (CDC) growth charts. Body weight percentiles were categorized as lesser than (\<) 5th, 5th to \< 95th, and greater than or equal to (\>=) 95th percentiles. Change from baseline in body weight at Week 6 was reported.
Time frame: Baseline, Week 6
Change From Baseline in Body Mass Index (BMI) at Week 6
BMI was derived from height and weight. BMI percentile was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI \< 5th percentile); Healthy weight (BMI 5th percentile up to \< 85th percentile); Overweight (BMI 85th percentile \< 95th percentile); Obese (BMI \>= 95th percentile). Change from baseline in body mass index at Week 6 was reported.
Time frame: Baseline, Week 6
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values
Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. ULN in measure data represents upper limit of normal, mcmol/L represents to Micromoles Per Litre, \> = represents greater than or equal to.
Time frame: Week 6
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Number of participants with potentially clinically significant changes in ECG parameters were reported. QTcF interval represents QT Fridericia's Correction Formula interval, QTcB interval represents QTc corrected by Bazett's in measure data.
Time frame: Week 6
Children's Sleep Habits Questionnaire (CSHQ) at Week 6
Children's Sleep Habits Questionnaire was a tool designed to screen the most common sleep problems in children, and consisted of 33 items for scoring. The instrument evaluated the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, 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, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.
Time frame: Week 6
Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS)
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: Up to Week 6
The study was conducted at 49 sites in United States between 06 September 2017 (first participant enrolled) and 23 October 2018 (last participant completed).
| Milestone | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Started | 46 | 40 | 37 | 37 | 39 |
| Received treatment | 45 | 39 | 35 | 34 | 38 |
| Completed | 37 | 32 | 26 | 30 | 25 |
| Not completed | 9 | 8 | 11 | 7 | 14 |
| Withdrew: Adverse event | 2 | 0 | 2 | 2 | 4 |
| Withdrew: Lost to follow-up | 2 | 2 | 1 | 1 | 5 |
| Withdrew: Protocol violation | 0 | 0 | 2 | 0 | 1 |
| Withdrew: Withdrawal by participant or parent/lar | 4 | 5 | 1 | 0 | 2 |
| Withdrew: Other: unspecified | 0 | 0 | 3 | 1 | 1 |
| Withdrew: Participant who did not received anydose | 1 | 1 | 2 | 3 | 1 |
ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Full analysis set (FAS) consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.
| Score on a scale | Placebo | Pooled SPD489 Doses (10, 20, and 30 mg) |
|---|---|---|
| Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6 | -9.1 ± 2.36 | -14.2 ± 1.57 |
CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. FAS consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.
| Score on a scale | Placebo | Pooled SPD489 Doses (10, 20, and 30 mg) |
|---|---|---|
| Clinical Global Impressions Global Improvement (CGI-I) at Week 6 | 3.4 ± 0.18 | 2.8 ± 0.13 |
Dose response relationship was evaluated by using the ADHD-RS Preschool Version Total Score. ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Dose response analysis set consisted of all participants in the safety analysis set who had at least 1 valid primary efficacy measurement on the randomized target dose level of the investigational product.
| Score on a scale | Placebo | SPD489 30 mg | SPD489 20 mg | SPD489 10 mg | SPD489 5 mg |
|---|---|---|---|---|---|
| Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6 | -9.1 ± 2.36 | -15.3 ± 2.62 | -17.0 ± 2.90 | -10.8 ± 2.63 | -13.5 ± 2.53 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a investigational product (IP) and that does not necessarily had a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of IP and no later than 3 days following the last dose of IP.
| Participants | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 19 | 13 | 15 | 18 | 22 |
Vital sign assessments included blood pressure (systolic and diastolic), average pulse rate. Number of participants with potentially clinically significant changes in vital signs were reported. mmHg represents millimetre of mercury in the outcome measure data.
| Participants | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Pulse: >=130 beats per minute (bpm), Week 6 | 0 | 0 | 0 | 0 | 0 |
| Pulse: <=55 bpm, Week 6 | 0 | 0 | 0 | 0 | 0 |
| Systolic Blood Pressure (BP): >=120 mmHg, Week 6 | 0 | 0 | 0 | 1 | 0 |
| Systolic BP: <75 mmHg, Week 6 | 0 | 0 | 0 | 0 | 0 |
| Diastolic BP: >=85 mmHg, Week 6 | 0 | 0 | 0 | 0 | 0 |
| Diastolic BP: <40 mmHg, Week 6 | 0 | 0 | 0 | 0 | 0 |
Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor.
| Centimeter | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Change From Baseline in Height at Week 6 | 0.7 ± 1.21 | 0.7 ± 1.50 | 0.7 ± 1.08 | 1.0 ± 1.29 | 0.5 ± 1.20 |
Body weight was measured in percentile without shoes. Body weight percentile was normalized by sex and age using the Centers for Disease Control and Prevention (CDC) growth charts. Body weight percentiles were categorized as lesser than (\<) 5th, 5th to \< 95th, and greater than or equal to (\>=) 95th percentiles. Change from baseline in body weight at Week 6 was reported.
| Weight percentile | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Change From Baseline in Body Weight at Week 6 | -1.1 ± 5.94 | -1.0 ± 8.00 | -2.8 ± 6.37 | -4.8 ± 9.59 | -5.8 ± 8.05 |
BMI was derived from height and weight. BMI percentile was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI \< 5th percentile); Healthy weight (BMI 5th percentile up to \< 85th percentile); Overweight (BMI 85th percentile \< 95th percentile); Obese (BMI \>= 95th percentile). Change from baseline in body mass index at Week 6 was reported.
| BMI percentile | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Change From Baseline in Body Mass Index (BMI) at Week 6 | -1.6 ± 11.17 | -0.9 ± 14.06 | -5.1 ± 10.49 | -6.7 ± 14.28 | -7.4 ± 11.91 |
Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. ULN in measure data represents upper limit of normal, mcmol/L represents to Micromoles Per Litre, \> = represents greater than or equal to.
| Participants | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Eosinophils/Leukocytes: Greater than (>)10% | 1 | 0 | 2 | 5 | 0 |
| Lymphocytes/Leukocytes: Greater than (>) 70% | 1 | 0 | 0 | 0 | 0 |
| Neutrophils/Leukocytes: Less than (<) 30% | 6 | 2 | 1 | 3 | 1 |
| Platelets: >600x10^9/Litre (L) | 0 | 0 | 0 | 0 | 1 |
| Alanine aminotransferase: >= 3x ULN | 1 | 0 | 0 | 0 | 0 |
| Aspartate aminotransferase: >=3x ULN | 1 | 0 | 0 | 0 | 0 |
| Creatinine: >176.8 mcmol/L or >1.5x ULN | 0 | 0 | 0 | 1 | 0 |
| Glucose: <3.05 Millimole per liter (mmol/L) | 1 | 1 | 0 | 0 | 0 |
| Glucose: >8.88 Millimole per liter (mmol/L) | 0 | 0 | 1 | 0 | 0 |
| Potassium: >5.5 Millimole per liter (mmol/L) | 1 | 0 | 0 | 0 | 0 |
| Ketones: Positive value (excluding trace) | 1 | 0 | 2 | 3 | 3 |
| Occult blood: Positive value (excluding trace) | 1 | 0 | 1 | 1 | 3 |
| Protein: Positive value (excluding trace) | 7 | 1 | 3 | 4 | 5 |
Number of participants with potentially clinically significant changes in ECG parameters were reported. QTcF interval represents QT Fridericia's Correction Formula interval, QTcB interval represents QTc corrected by Bazett's in measure data.
| Participants | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Heart Rate (< 55 Beats per minute) | 0 | 0 | 0 | 0 | 0 |
| Heart Rate (> 130 Beats per minute) | 0 | 0 | 0 | 0 | 0 |
| QRS Interval (> = 90 millisecond [msec]) | 1 | 1 | 0 | 1 | 2 |
| QT Interval (> = 440 msec) | 0 | 0 | 0 | 0 | 0 |
| QTcB Interval (> =440 msec and <480 msec) | 1 | 1 | 2 | 3 | 2 |
| QTcB Interval (>=480 msec and <500 msec) | 0 | 0 | 0 | 0 | 0 |
| QTcB Interval (>=500 msec) | 0 | 0 | 0 | 0 | 0 |
| QTcF Interval (> =440 msec and <480 msec) | 0 | 0 | 0 | 0 | 0 |
| QTcF Interval (>=480 msec and <500 msec) | 0 | 0 | 0 | 0 | 0 |
| QTcF Interval (>=500 msec) | 0 | 0 | 0 | 0 | 0 |
| ECG Abnormality - Rhythm | 0 | 1 | 0 | 0 | 0 |
Children's Sleep Habits Questionnaire was a tool designed to screen the most common sleep problems in children, and consisted of 33 items for scoring. The instrument evaluated the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, 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, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.
| Score on scale | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Bedtime resistance: Week 6 | 9.7 ± 3.22 | 9.4 ± 3.30 | 10.3 ± 3.36 | 10.2 ± 3.60 | 10.3 ± 3.30 |
| Sleep-onset delay: Week 6 | 1.7 ± 0.74 | 1.7 ± 0.80 | 1.8 ± 0.75 | 1.8 ± 0.75 | 1.8 ± 0.76 |
| Sleep duration: Week 6 | 3.9 ± 1.20 | 3.9 ± 1.20 | 3.9 ± 1.35 | 4.1 ± 1.70 | 4.1 ± 1.62 |
| Sleep anxiety: Week 6 | 5.7 ± 2.37 | 5.8 ± 2.17 | 6.5 ± 2.36 | 6.5 ± 2.75 | 6.4 ± 2.37 |
| Night wakings: Week 6 | 4.7 ± 1.78 | 4.2 ± 1.23 | 4.6 ± 1.58 | 4.3 ± 1.36 | 4.1 ± 1.39 |
| Parasomnias: Week 6 | 8.6 ± 1.97 | 8.9 ± 1.70 | 8.8 ± 1.50 | 8.2 ± 1.54 | 8.4 ± 1.34 |
| Sleep-disordered breathing: Week 6 | 3.5 ± 1.00 | 3.6 ± 1.02 | 3.3 ± 0.68 | 3.4 ± 0.70 | 3.5 ± 0.95 |
| Daytime sleepiness: Week 6 | 10.9 ± 3.58 | 10.9 ± 3.33 | 10.3 ± 3.33 | 9.8 ± 3.57 | 12.4 ± 4.46 |
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.
| Participants | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS) | 0 | 1 | 1 | 1 | 0 |
Collected over From start of the study drug administration up to follow up (Week 7). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/45 (0%) | 0/45 (0%) | 4/45 (8.9%) |
| SPD489 5 mg | 0/39 (0%) | 0/39 (0%) | 8/39 (20.5%) |
| SPD489 10 mg | 0/35 (0%) | 0/35 (0%) | 11/35 (31.4%) |
| SPD489 20 mg | 0/34 (0%) | 0/34 (0%) | 14/34 (41.2%) |
| SPD489 30 mg | 0/38 (0%) | 0/38 (0%) | 18/38 (47.4%) |
| Event | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg |
|---|---|---|---|---|---|
| Decreased appetiteMetabolism and nutrition disorders | 4/45 | 3/39 | 3/35 | 6/34 | 8/38 |
| IrritabilityPsychiatric disorders | 0/45 | 3/39 | 4/35 | 3/34 | 4/38 |
| Affect labilityPsychiatric disorders | 0/45 | 2/39 | 3/35 | 1/34 | 1/38 |
| Initial insomniaPsychiatric disorders | 2/45 | 1/39 | 1/35 | 0/34 | 3/38 |
| ConstipationGastrointestinal disorders | 1/45 | 0/39 | 0/35 | 2/34 | 0/38 |
| NasopharyngitisInfections and infestations | 0/45 | 1/39 | 0/35 | 2/34 | 2/38 |
| Weight decreasedInvestigations | 0/45 | 0/39 | 0/35 | 2/34 | 0/38 |
| HeadacheNervous system disorders | 0/45 | 0/39 | 1/35 | 2/34 | 0/38 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/45 | 1/39 | 2/35 | 2/34 | 2/38 |
| Upper respiratory tract infectionInfections and infestations | 1/45 | 2/39 | 2/35 | 0/34 | 0/38 |
Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product.
| Age, Continuous(months) | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 61.9 ± 6.32 | 60.7 ± 6.32 | 60.9 ± 7.18 | 61.1 ± 5.88 | 61.2 ± 7.23 | 61.2 ± 6.54 |
| Sex: Female, Male(Participants) | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg | Total |
|---|---|---|---|---|---|---|
| Female | 16 | 12 | 13 | 10 | 11 | 62 |
| Male | 29 | 27 | 22 | 24 | 27 | 129 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 8 | 6 | 11 | 2 | 5 | 32 |
| Not Hispanic or Latino | 37 | 33 | 24 | 32 | 33 | 159 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | SPD489 5 mg | SPD489 10 mg | SPD489 20 mg | SPD489 30 mg | Total |
|---|---|---|---|---|---|---|
| Race — White | 19 | 17 | 18 | 18 | 17 | 89 |
| Race — Black or African American | 23 | 20 | 15 | 15 | 16 | 89 |
| Race — American Indian or Alaska Native | 0 | 0 | 0 | 0 | 1 | 1 |
| Race — Multiple | 1 | 1 | 0 | 1 | 3 | 6 |
| Race — Other: Not specified | 1 | 1 | 2 | 0 | 1 | 5 |
| Race — Missing | 1 | 0 | 0 | 0 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
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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