Trial Outcomes & Findings for Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 (NCT NCT00763971)
NCT ID: NCT00763971
Last Updated: 2021-06-14
Results Overview
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
336 participants
Primary outcome timeframe
Baseline and up to 7 weeks
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
Lisdexamfetamine Dimesylate (LDX)
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
113
|
112
|
111
|
|
Overall Study
COMPLETED
|
80
|
74
|
42
|
|
Overall Study
NOT COMPLETED
|
33
|
38
|
69
|
Reasons for withdrawal
| Measure |
Lisdexamfetamine Dimesylate (LDX)
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
4
|
|
Overall Study
Protocol Violation
|
3
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
11
|
22
|
54
|
|
Overall Study
Unable to swallow capsule
|
2
|
1
|
1
|
|
Overall Study
Personal reason
|
3
|
0
|
0
|
|
Overall Study
Exclusion criteria met
|
1
|
0
|
0
|
|
Overall Study
Sponsor decision
|
1
|
0
|
0
|
|
Overall Study
Due to holiday season
|
2
|
0
|
1
|
|
Overall Study
Randomization error
|
0
|
0
|
1
|
|
Overall Study
Medical monitor decision
|
0
|
0
|
1
|
|
Overall Study
Moved to another country
|
0
|
1
|
0
|
|
Overall Study
Subject wanted dose reduction
|
0
|
1
|
0
|
|
Overall Study
Lack of availability
|
0
|
1
|
0
|
|
Overall Study
Performed final visit on phone
|
0
|
1
|
0
|
|
Overall Study
Participation in 489-326 required
|
1
|
0
|
0
|
Baseline Characteristics
Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
Baseline characteristics by cohort
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=111 Participants
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=111 Participants
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=110 Participants
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10.9 years
STANDARD_DEVIATION 2.87 • n=93 Participants
|
10.9 years
STANDARD_DEVIATION 2.63 • n=4 Participants
|
11.0 years
STANDARD_DEVIATION 2.82 • n=27 Participants
|
10.9 years
STANDARD_DEVIATION 2.77 • n=483 Participants
|
|
Age, Customized
6-12 years
|
77 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
236 Participants
n=483 Participants
|
|
Age, Customized
13-17 years
|
34 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
96 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=93 Participants
|
90 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
268 Participants
n=483 Participants
|
|
Region of Enrollment
France
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Region of Enrollment
Hungary
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Region of Enrollment
Spain
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
Region of Enrollment
Poland
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
Germany
|
36 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
107 Participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Region of Enrollment
Italy
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Region of Enrollment
Sweden
|
18 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
52 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 7 weeksPopulation: Full Analysis set (FAS) defined as all subjects who were randomized and who took at least 1 dose of investigational product.
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=98 Participants
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=103 Participants
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=104 Participants
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks
|
-24.3 Scores on a scale
Standard Error 1.16
|
-18.7 Scores on a scale
Standard Error 1.14
|
-5.7 Scores on a scale
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Up to 7 weeksPopulation: FAS
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=100 Participants
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=104 Participants
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=104 Participants
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
|
78.0 percentage of participants
|
60.6 percentage of participants
|
14.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to 7 weeksPopulation: FAS
The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=96 Participants
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=99 Participants
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=100 Participants
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks
|
-24.5 Scores on a scale
Standard Error 1.70
|
-18.4 Scores on a scale
Standard Error 1.69
|
-3.2 Scores on a scale
Standard Error 1.69
|
SECONDARY outcome
Timeframe: Baseline and up to 7 weeksPopulation: FAS
HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=98 Participants
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=103 Participants
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=97 Participants
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks
Baseline
|
0.811 Scores on a scale
Standard Deviation 0.1451
|
0.822 Scores on a scale
Standard Deviation 0.1377
|
0.806 Scores on a scale
Standard Deviation 0.1460
|
|
Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks
Up to 7 weeks
|
0.878 Scores on a scale
Standard Deviation 0.1322
|
0.887 Scores on a scale
Standard Deviation 0.1151
|
0.843 Scores on a scale
Standard Deviation 0.1431
|
SECONDARY outcome
Timeframe: Baseline and up to 7 weeksPopulation: FAS
The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=78 Participants
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=75 Participants
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=80 Participants
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks
|
8.6 T-scores
Standard Error 1.08
|
7.1 T-scores
Standard Error 1.10
|
-0.2 T-scores
Standard Error 1.07
|
SECONDARY outcome
Timeframe: Baseline and up to 7 weeksPopulation: FAS
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=79 Participants
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=83 Participants
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=87 Participants
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks
|
-0.3 Scores on a scale
Standard Error 0.04
|
-0.3 Scores on a scale
Standard Error 0.04
|
0.0 Scores on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline and up to 7 weeksPopulation: Safety Population defined as all subjects who took at least 1 dose of investigational product.
The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=20 Participants
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=21 Participants
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=22 Participants
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks
|
-9.15 Scores on a scale
Standard Deviation 11.264
|
-9.71 Scores on a scale
Standard Deviation 6.936
|
-2.59 Scores on a scale
Standard Deviation 7.436
|
SECONDARY outcome
Timeframe: Up to 7 weeksPopulation: Safety Population
C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=25 Participants
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=29 Participants
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=27 Participants
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation
|
1 participants
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Non-suicidal self injurious behavior
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
Lisdexamfetamine Dimesylate (LDX)
Serious events: 3 serious events
Other events: 80 other events
Deaths: 0 deaths
Methylphenidate Hydrochloride
Serious events: 2 serious events
Other events: 72 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=111 participants at risk
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=111 participants at risk
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=110 participants at risk
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.90%
1/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.90%
1/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.90%
1/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Infections and infestations
Appendicitis
|
0.90%
1/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Nervous system disorders
Loss of conciousness
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Vascular disorders
Hematoma
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.90%
1/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
Other adverse events
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=111 participants at risk
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
|
Methylphenidate Hydrochloride
n=111 participants at risk
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
|
Placebo
n=110 participants at risk
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
6/111 • Number of events 6
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
3.6%
4/111 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
5.5%
6/110 • Number of events 10
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal upper pain
|
7.2%
8/111 • Number of events 15
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
8.1%
9/111 • Number of events 10
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
5.5%
6/110 • Number of events 9
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
5/111 • Number of events 8
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
1.8%
2/111 • Number of events 2
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
2.7%
3/110 • Number of events 3
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
10.8%
12/111 • Number of events 14
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
7.2%
8/111 • Number of events 8
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
2.7%
3/110 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
4/111 • Number of events 5
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
3.6%
4/111 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
General disorders
Fatigue
|
4.5%
5/111 • Number of events 5
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.90%
1/111 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
2.7%
3/110 • Number of events 3
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
General disorders
Irritability
|
3.6%
4/111 • Number of events 6
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
3.6%
4/111 • Number of events 5
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
General disorders
Pyrexia
|
2.7%
3/111 • Number of events 3
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
4.5%
5/111 • Number of events 5
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
3.6%
4/111 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
2.7%
3/111 • Number of events 3
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Infections and infestations
Influenza
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
2.7%
3/111 • Number of events 3
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
7.2%
8/111 • Number of events 9
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
12.6%
14/111 • Number of events 14
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
7.3%
8/110 • Number of events 9
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
3/111 • Number of events 3
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.90%
1/111 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
1.8%
2/110 • Number of events 2
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
3.6%
4/111 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Wrong drug administered
|
3.6%
4/111 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
1.8%
2/111 • Number of events 2
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Investigations
Electrocardiogram QT prolonged
|
2.7%
3/111 • Number of events 7
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.90%
1/111 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Investigations
Weight decreased
|
13.5%
15/111 • Number of events 15
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
4.5%
5/111 • Number of events 5
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.8%
12/111 • Number of events 13
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
5.4%
6/111 • Number of events 8
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
1.8%
2/110 • Number of events 2
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.2%
28/111 • Number of events 31
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
15.3%
17/111 • Number of events 21
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
2.7%
3/110 • Number of events 3
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Nervous system disorders
Dizziness
|
3.6%
4/111 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
1.8%
2/111 • Number of events 2
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Nervous system disorders
Headache
|
14.4%
16/111 • Number of events 21
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
19.8%
22/111 • Number of events 30
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
20.0%
22/110 • Number of events 27
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Nervous system disorders
Migraine
|
2.7%
3/111 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.90%
1/111 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Psychiatric disorders
Aggression
|
3.6%
4/111 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
2.7%
3/111 • Number of events 3
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Psychiatric disorders
Initial insomnia
|
2.7%
3/111 • Number of events 3
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
6.3%
7/111 • Number of events 7
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Psychiatric disorders
Insomnia
|
14.4%
16/111 • Number of events 16
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
8.1%
9/111 • Number of events 9
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Psychiatric disorders
Sleep disorder
|
5.4%
6/111 • Number of events 6
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
1.8%
2/111 • Number of events 2
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.91%
1/110 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Psychiatric disorders
Tic
|
1.8%
2/111 • Number of events 2
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
2.7%
3/111 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
1.8%
2/110 • Number of events 2
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
3/111 • Number of events 3
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
7.2%
8/111 • Number of events 8
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/110
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.90%
1/111 • Number of events 1
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
0.00%
0/111
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
2.7%
3/110 • Number of events 4
Safety Population defined as all subjects who took at least 1 dose of investigational product.
|
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