Trial Outcomes & Findings for A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD (NCT NCT02683265)
NCT ID: NCT02683265
Last Updated: 2023-02-21
Results Overview
ADHD-RS-IV is 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often. The total score is the sum of the scores for all 18 items and could range from 0 (no impairment) to 54 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents. The ADHD-RS-IV Preschool Version was used to determine eligibility, optimal dosing and the efficacy of double blind treatment.
COMPLETED
PHASE4
158 participants
2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
2023-02-21
Participant Flow
The Enrolled Population consisted of all subjects who were not screen failures. Of these enrolled subjects, 119 entered the Open-label Treatment Phase and 90 were randomized to the Double-blind Treatment Phase.
Participant milestones
| Measure |
Open-label Treatment Phase
6-week open-label treatment phase. Aptensio XR capsules administered orally, once daily.
|
Aptensio XR
Optimized dose of Aptensio XR administered orally, once daily.
|
Placebo Comparator
Placebo capsules administered orally, once daily.
|
|---|---|---|---|
|
Open-label Treatment Phase
STARTED
|
119
|
0
|
0
|
|
Open-label Treatment Phase
COMPLETED
|
90
|
0
|
0
|
|
Open-label Treatment Phase
NOT COMPLETED
|
29
|
0
|
0
|
|
Double-blind Treatment Phase
STARTED
|
0
|
40
|
50
|
|
Double-blind Treatment Phase
COMPLETED
|
0
|
38
|
48
|
|
Double-blind Treatment Phase
NOT COMPLETED
|
0
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD
Baseline characteristics by cohort
| Measure |
Aptensio XR
n=40 Participants
Optimized dose of Aptensio XR administered orally, once daily.
|
Placebo Comparator
n=50 Participants
Placebo capsules administered orally, once daily.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 months
STANDARD_DEVIATION 5.59 • n=5 Participants
|
59.2 months
STANDARD_DEVIATION 6.42 • n=7 Participants
|
58.9 months
STANDARD_DEVIATION 6.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.Population: The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment.
ADHD-RS-IV is 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often. The total score is the sum of the scores for all 18 items and could range from 0 (no impairment) to 54 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents. The ADHD-RS-IV Preschool Version was used to determine eligibility, optimal dosing and the efficacy of double blind treatment.
Outcome measures
| Measure |
Aptensio XR
n=39 Participants
Optimized dose of Aptensio XR administered orally, once daily.
|
Placebo Comparator
n=49 Participants
Placebo capsules administered orally, once daily.
|
|---|---|---|
|
Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Total Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
|
6.3 score on a scale
Standard Deviation 12.26
|
17.3 score on a scale
Standard Deviation 16.76
|
SECONDARY outcome
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.Population: The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment.
This 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Hyperactivity-Impulsivity even items. The Hyperactivity-Impulsivity subscale score was the sum of the scores for the 9 even items and could range from 0 (no impairment) to 27 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents.
Outcome measures
| Measure |
Aptensio XR
n=39 Participants
Optimized dose of Aptensio XR administered orally, once daily.
|
Placebo Comparator
n=50 Participants
Placebo capsules administered orally, once daily.
|
|---|---|---|
|
Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Hyperactivity-Impulsivity Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
|
3.36 score on a scale
Standard Deviation 6.434
|
9.37 score on a scale
Standard Deviation 8.762
|
SECONDARY outcome
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.Population: The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment.
This 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Inattention subscales were based upon the sum of the odd items. The Inattention subscale score was the sum of the scores for the 9 odd items and could range from 0 (no impairment) to 27 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents.
Outcome measures
| Measure |
Aptensio XR
n=39 Participants
Optimized dose of Aptensio XR administered orally, once daily.
|
Placebo Comparator
n=49 Participants
Placebo capsules administered orally, once daily.
|
|---|---|---|
|
Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Inattention Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
|
2.9 score on a scale
Standard Deviation 6.48
|
7.9 score on a scale
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.Population: The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment.
The scale provides a global rating of illness severity during the trial. The subject is rated relative to the clinician's past experience with other subjects who have the same diagnosis. The CGI-S scale is 1 question and rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill subjects). A lower value a better the outcome.
Outcome measures
| Measure |
Aptensio XR
n=39 Participants
Optimized dose of Aptensio XR administered orally, once daily.
|
Placebo Comparator
n=50 Participants
Placebo capsules administered orally, once daily.
|
|---|---|---|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
Baseline · 6 = Severely ill
|
1 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
Baseline · 7 = Among the most extremely ill subjects
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
End of Double-blind Treatment · 1 = Normal, not at all ill
|
4 Participants
|
3 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
End of Double-blind Treatment · 7 = Among the most extremely ill subjects
|
0 Participants
|
2 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
Baseline · 1 = Normal, not at all ill
|
7 Participants
|
13 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
Baseline · 2 = Borderline mentally ill
|
15 Participants
|
14 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
Baseline · 3 = Mildly ill
|
8 Participants
|
11 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
Baseline · 4 = Moderately ill
|
7 Participants
|
11 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
Baseline · 5 = Markedly ill
|
1 Participants
|
1 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
End of Double-blind Treatment · 2 = Borderline mentally ill
|
12 Participants
|
5 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
End of Double-blind Treatment · 3 = Mildly ill
|
5 Participants
|
4 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
End of Double-blind Treatment · 4 = Moderately ill
|
6 Participants
|
10 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
End of Double-blind Treatment · 5 = Markedly ill
|
10 Participants
|
19 Participants
|
|
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
End of Double-blind Treatment · 6 = Severely ill
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.Population: The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment.
The scale provides a global rating of illness improvement during the trial. The subject is rated relative to the clinician's past experience with other subjects who have the same diagnosis. The CGI-I scale is 1 question, and rates improvement compared with a baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A lower value is a better the outcome.
Outcome measures
| Measure |
Aptensio XR
n=39 Participants
Optimized dose of Aptensio XR administered orally, once daily.
|
Placebo Comparator
n=50 Participants
Placebo capsules administered orally, once daily.
|
|---|---|---|
|
Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline).
1 = Very much improved
|
6 Participants
|
5 Participants
|
|
Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline).
2 = Much improved
|
8 Participants
|
6 Participants
|
|
Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline).
3 = Minimally improved
|
3 Participants
|
4 Participants
|
|
Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline).
4 = No change
|
11 Participants
|
13 Participants
|
|
Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline).
5 = Minimally worse
|
4 Participants
|
1 Participants
|
|
Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline).
6 = Much worse
|
6 Participants
|
16 Participants
|
|
Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline).
7 = Very much worse
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.Population: The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment.
Conners EC BEH-P(S) is an assessment tool used to obtain a parent's observations about his/her child's behavior. This tool is designed to assess a range of behavioral, emotional, \& social issues in young children. The tool consists of 47 items, responses to which are summarized in 6 behavioral scales \& 2 validity scales. Items on Conners assessment are rated on a Likert scale ranging from 0-3. The ratings were converted to raw item scores. Raw item scores were grouped, standardized, and/or compared to lookup tables for interpretation. Assessments were presented as T-scores: item raw scores for a given scale are added together; this raw sum is compared to age- and gender-matched normative data and converted to a T-score. Higher scores indicate higher concerns. T-score is a standard score with a mean of 50 and standard deviation of 10. Note that Conners assessments do not use T-scores greater than 90; raw scores that produce extremely high T-scores are reported as ''T-score \>= 90."
Outcome measures
| Measure |
Aptensio XR
n=39 Participants
Optimized dose of Aptensio XR administered orally, once daily.
|
Placebo Comparator
n=50 Participants
Placebo capsules administered orally, once daily.
|
|---|---|---|
|
Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind
Inattention/Hyperactivity
|
1.92 T-score
Standard Deviation 11.412
|
7.73 T-score
Standard Deviation 15.067
|
|
Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind
Defiant/Aggressive Behaviors
|
1.00 T-score
Standard Deviation 11.016
|
3.67 T-score
Standard Deviation 11.033
|
|
Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind
Mood and Affect
|
2.63 T-score
Standard Deviation 11.780
|
5.13 T-score
Standard Deviation 12.335
|
|
Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind
Physical Symptoms
|
1.92 T-score
Standard Deviation 13.200
|
-0.15 T-score
Standard Deviation 11.130
|
|
Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind
Social Functioning / Atypical Behaviors
|
3.79 T-score
Standard Deviation 10.437
|
3.83 T-score
Standard Deviation 11.960
|
|
Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind
Anxiety
|
1.89 T-score
Standard Deviation 10.211
|
-0.02 T-score
Standard Deviation 8.299
|
Adverse Events
Open-label Treatment Phase
Aptensio XR
Placebo Comparator
Serious adverse events
| Measure |
Open-label Treatment Phase
n=119 participants at risk
6-week open-label treatment phase. Aptensio XR capsules administered orally, once daily.
|
Aptensio XR
n=40 participants at risk
Optimized dose of Aptensio XR administered orally, once daily.
|
Placebo Comparator
n=50 participants at risk
Placebo capsules administered orally, once daily.
|
|---|---|---|---|
|
Infections and infestations
Campylobacter infection
|
0.84%
1/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
Other adverse events
| Measure |
Open-label Treatment Phase
n=119 participants at risk
6-week open-label treatment phase. Aptensio XR capsules administered orally, once daily.
|
Aptensio XR
n=40 participants at risk
Optimized dose of Aptensio XR administered orally, once daily.
|
Placebo Comparator
n=50 participants at risk
Placebo capsules administered orally, once daily.
|
|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
15.1%
18/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Psychiatric disorders
Irritability
|
14.3%
17/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Psychiatric disorders
Emotional Disorder
|
11.8%
14/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
2.0%
1/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Psychiatric disorders
Affect lability
|
10.1%
12/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Psychiatric disorders
Initial insomnia
|
6.7%
8/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.0%
25/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
2.5%
1/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Investigations
Weight decreased
|
17.6%
21/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Vascular disorders
Hypertension
|
13.4%
16/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
7.5%
3/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
8/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
7/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
2.0%
1/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Nervous system disorders
Headache
|
7.6%
9/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
General disorders
Pyrexia
|
5.9%
7/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
2.0%
1/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
6/119 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
5.0%
2/40 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
0.00%
0/50 • The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place