Trial Outcomes & Findings for Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT01328756)
NCT ID: NCT01328756
Last Updated: 2021-06-10
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
314 participants
Primary outcome timeframe
Baseline up to 3 days after the last dose of study treatment (up to 2 years)
Results posted on
2021-06-10
Participant Flow
This study enrolled participants from 3 antecedent studies (SPD489-317 \[NCT01106430\], SPD489-325 \[NCT00763971\], and SPD489-326 \[NCT00784654\]), or directly enrolled.
If participants from previous SDP489 studies had a gap of more than 7 days before participation in this study, they were required to have baseline Attention-Deficit/Hyperactivity Disorder (ADHD) total score of at least 28, to be enrolled. Of 348 participants screened, 314 participants were enrolled and treated.
Participant milestones
| Measure |
Lisdexamfetamine Dimesylate
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 milligram (mg) capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period. At optimization period, participants started SPD489 30 mg and dose was titrated until acceptable response (30% reduction from baseline in ADHD Rating Scale-IV total score, clinical global impression-improvement \[CGI-I\]score of 1 or 2 with tolerable side effects) was achieved. Maximum dose was 70mg. Dose adjustments were done in dose maintenance period.
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|---|---|
|
Overall Study
STARTED
|
314
|
|
Overall Study
COMPLETED
|
191
|
|
Overall Study
NOT COMPLETED
|
123
|
Reasons for withdrawal
| Measure |
Lisdexamfetamine Dimesylate
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 milligram (mg) capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period. At optimization period, participants started SPD489 30 mg and dose was titrated until acceptable response (30% reduction from baseline in ADHD Rating Scale-IV total score, clinical global impression-improvement \[CGI-I\]score of 1 or 2 with tolerable side effects) was achieved. Maximum dose was 70mg. Dose adjustments were done in dose maintenance period.
|
|---|---|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Adverse Event
|
39
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Withdrawal by Subject
|
41
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Other
|
29
|
Baseline Characteristics
Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Lisdexamfetamine Dimesylate
n=314 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 2.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
250 Participants
n=5 Participants
|
|
Clinical Global Impressions - Severity of Illness (CGI-S) Rating
Normal, not all ill
|
0 Participants
n=5 Participants
|
|
Clinical Global Impressions - Severity of Illness (CGI-S) Rating
Borderline mentally ill
|
0 Participants
n=5 Participants
|
|
Clinical Global Impressions - Severity of Illness (CGI-S) Rating
Mildly ill
|
1 Participants
n=5 Participants
|
|
Clinical Global Impressions - Severity of Illness (CGI-S) Rating
Moderately ill
|
69 Participants
n=5 Participants
|
|
Clinical Global Impressions - Severity of Illness (CGI-S) Rating
Markedly ill
|
152 Participants
n=5 Participants
|
|
Clinical Global Impressions - Severity of Illness (CGI-S) Rating
Severely ill
|
81 Participants
n=5 Participants
|
|
Clinical Global Impressions - Severity of Illness (CGI-S) Rating
Among the most extremely ill participants
|
11 Participants
n=5 Participants
|
|
Body Weight
|
46.13 kilogram(s)
STANDARD_DEVIATION 16.434 • n=5 Participants
|
|
Height
|
152.29 centimeters
STANDARD_DEVIATION 16.633 • n=5 Participants
|
|
Body Mass Index (BMI)
|
19.22 kilogram per square meter
STANDARD_DEVIATION 3.389 • n=5 Participants
|
|
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): Total Score
|
41.1 scores on a scale
STANDARD_DEVIATION 7.03 • n=5 Participants
|
|
ADHD-RS-IV: Inattention Subscale Score
|
22.1 scores on a scale
STANDARD_DEVIATION 3.52 • n=5 Participants
|
|
ADHD-RS-IV: Hyperactivity/Impulsivity Subscore
|
19 scores on a scale
STANDARD_DEVIATION 5.86 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 3 days after the last dose of study treatment (up to 2 years)Population: Safety population included all participants who took at least 1 dose of Lisdexamfetamine dimesylate during this study.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=314 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
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|---|---|
|
Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Any TEAE
|
282 participants
|
|
Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAE
|
28 participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Safety population with participants evaluable for this outcome
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=313 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)
|
7 beats per minute
Standard Deviation 11.6
|
PRIMARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Safety population with participants evaluable for this outcome
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=313 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)
|
3.2 mmHg
Standard Deviation 9.05
|
PRIMARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Safety population with participants evaluable for this outcome
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=313 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)
|
3.4 mmHg
Standard Deviation 10.33
|
PRIMARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Safety population with participants evaluable for this outcome
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=313 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)
|
2.1 kilogram(s)
Standard Deviation 5.83
|
PRIMARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Safety population with participants evaluable for this outcome
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=301 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in Height at Last On-treatment Assessment (LOTA)
|
6.1 centimeter(s)
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Safety population with participants evaluable for this outcome
BMI was calculated as (weight \[kilogram\] per height \[square meter\]).
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=313 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)
|
-0.5 kilogram per square meter
Standard Deviation 1.72
|
PRIMARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Safety population with participants evaluable for this outcome
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=303 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)
|
7.1 beats per minute
Standard Deviation 13.51
|
PRIMARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Safety population with participants evaluable for this outcome
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=302 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)
|
-10.3 milliseconds
Standard Deviation 23.53
|
PRIMARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Safety population with participants evaluable for this outcome
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=302 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)
|
-0.6 milliseconds
Standard Deviation 15.24
|
PRIMARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Safety population with participants evaluable for this outcome
The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=313 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)
|
-10.3 scores on a scale
Standard Deviation 9.64
|
SECONDARY outcome
Timeframe: Baseline (Week 0), LOTA (Week 104)Population: Full Analysis Set (FAS) population included all participants who took at least 1 dose of SPD489 and had at least 1 on-treatment post baseline efficacy assessment.
ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=299 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)
|
-25.8 Scores on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: LOTA (Week 104)Population: FAS population
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=299 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
Very much improved
|
141 participants
|
|
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
Much improved
|
92 participants
|
|
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
Minimally improved
|
28 participants
|
|
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
No change
|
20 participants
|
|
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
Minimally worse
|
13 participants
|
|
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
Much worse
|
5 participants
|
|
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
Very much worse
|
0 participants
|
SECONDARY outcome
Timeframe: LOTA (Week 104)Population: FAS population
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate
n=299 Participants
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
|
|---|---|
|
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
Among the most extremely ill participants
|
2 participants
|
|
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
Normal, not all ill
|
73 participants
|
|
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
Borderline mentally ill
|
97 participants
|
|
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
Mildly ill
|
67 participants
|
|
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
Moderately ill
|
39 participants
|
|
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
Markedly ill
|
17 participants
|
|
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
Severely ill
|
4 participants
|
Adverse Events
Lisdexamfetamine Dimesylate
Serious events: 28 serious events
Other events: 250 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lisdexamfetamine Dimesylate
n=314 participants at risk
Lisdexamfetamine dimesylate (Vyvanse, SPD489) 30 to 70 mg capsule once daily orally.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Gastrointestinal disorders
Dental caries
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Gastrointestinal disorders
Disbacteriosis
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
General disorders
Condition aggravated
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
General disorders
Pyrexia
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Appendicitis
|
0.96%
3/314 • Number of events 3 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Cellulitis
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Infectious peritonitis
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Lobar pneumonia
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Mumps
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Oral herpes
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.64%
2/314 • Number of events 2 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Injury, poisoning and procedural complications
Agitation postoperative
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Nervous system disorders
Migraine
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Nervous system disorders
Syncope
|
1.9%
6/314 • Number of events 7 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Psychiatric disorders
Oppositional defiant disorder
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Psychiatric disorders
Panic attack
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.32%
1/314 • Number of events 1 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
Other adverse events
| Measure |
Lisdexamfetamine Dimesylate
n=314 participants at risk
Lisdexamfetamine dimesylate (Vyvanse, SPD489) 30 to 70 mg capsule once daily orally.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.2%
29/314 • Number of events 37 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.9%
28/314 • Number of events 34 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Gastrointestinal disorders
Nausea
|
9.9%
31/314 • Number of events 41 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
27/314 • Number of events 33 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
General disorders
Irritability
|
11.5%
36/314 • Number of events 39 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
General disorders
Pyrexia
|
9.9%
31/314 • Number of events 40 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Gastroenteritis
|
5.7%
18/314 • Number of events 21 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Nasopharyngitis
|
23.2%
73/314 • Number of events 129 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Infections and infestations
Pharyngitis
|
5.1%
16/314 • Number of events 18 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Investigations
Weight decreased
|
20.1%
63/314 • Number of events 68 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
54.1%
170/314 • Number of events 214 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Nervous system disorders
Headache
|
21.7%
68/314 • Number of events 139 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Psychiatric disorders
Depressed mood
|
6.1%
19/314 • Number of events 20 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Psychiatric disorders
Initial insomnia
|
12.1%
38/314 • Number of events 46 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Psychiatric disorders
Insomnia
|
19.1%
60/314 • Number of events 75 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Psychiatric disorders
Tic
|
5.7%
18/314 • Number of events 25 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
22/314 • Number of events 25 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
18/314 • Number of events 24 • Baseline up to 3 days after the last dose of study treatment (up to 2 years)
AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER