Trial Outcomes & Findings for An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder (NCT NCT01323192)
NCT ID: NCT01323192
Last Updated: 2013-09-06
Results Overview
CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.
COMPLETED
PHASE3
284 participants
Baseline (Day 0) to Endpoint (Week 8)
2013-09-06
Participant Flow
The study was conducted at 39 study sites in Japan.
284 participants were randomly assigned and treated with JNS001 or placebo in this study. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
Participant milestones
| Measure |
JNS001
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
Participants received matching placebo orally once daily for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
141
|
|
Overall Study
COMPLETED
|
134
|
135
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
JNS001
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
Participants received matching placebo orally once daily for 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Noncompliance with study medication
|
0
|
3
|
|
Overall Study
Nonmedical reasons
|
0
|
1
|
Baseline Characteristics
An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder
Baseline characteristics by cohort
| Measure |
JNS001
n=143 Participants
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
n=141 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-24 years of age
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Customized
25-35 years of age
|
60 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Age, Customized
36-49 years of age
|
55 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Age, Customized
50-64 years of age
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
143 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Endpoint (Week 8)Population: Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.
Outcome measures
| Measure |
JNS001
n=143 Participants
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
n=140 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline to Endpoint in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Scores of Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV)
|
-12.5 Scores on a scale
Standard Deviation 9.27
|
-7.9 Scores on a scale
Standard Deviation 9.61
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Endpoint (Week 8)Population: Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment.
CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O: SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.
Outcome measures
| Measure |
JNS001
n=143 Participants
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
n=140 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) Total Score Other Than Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Score
|
-19.5 Scores on a scale
Standard Deviation 15.42
|
-12.5 Scores on a scale
Standard Deviation 15.87
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Endpoint (Week 8)Population: Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.
Outcome measures
| Measure |
JNS001
n=143 Participants
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
n=140 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores
|
-1.0 Scores on a scale
Full Range 16.45 • Interval -5.0 to 1.0
|
-1.0 Scores on a scale
Full Range 16.55 • Interval -4.0 to 2.0
|
SECONDARY outcome
Timeframe: Endpoint (Week 8)Population: Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.
Outcome measures
| Measure |
JNS001
n=143 Participants
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
n=140 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
|---|---|---|
|
Clinical Global Impression of Change (CGI-C) Scores
|
3 Scores on a scale
Interval 1.0 to 6.0
|
3 Scores on a scale
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Endpoint (Week 8)Population: Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
CAARS-S:SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-S:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.
Outcome measures
| Measure |
JNS001
n=143 Participants
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
n=140 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in the Conners' Adult Attention Deficit-Hyperactivity Disorder (ADHD) Rating Scales-Self Report: Screening Version (CAARS-S:SV) Score
|
-18.0 Scores on a scale
Standard Deviation 16.45
|
-10.9 Scores on a scale
Standard Deviation 16.55
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Endpoint (Week 8)Population: Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
Q-LES-Q-SF is a 16-item questionnaire in which each question is rated on a 5-point scale with scores ranging from "1 = very poor" to "5 = very good". The total raw score is calculated by summing up the scores for the 16 items. The raw total score is transformed into a percentage maximum possible score using the following formula:(raw total score -minimum score) / (maximum possible raw score -minimum score). The minimum raw score on the Q-LES-Q-SF is 16 (worst), and the maximum score is 80 (best). A higher score indicates a better quality of life.
Outcome measures
| Measure |
JNS001
n=143 Participants
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
n=140 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores
|
2.4 Scores on a scale
Standard Deviation 14.00 • Interval -5.0 to 1.0
|
0.8 Scores on a scale
Standard Deviation 12.69 • Interval -4.0 to 2.0
|
Adverse Events
JNS001
Placebo
Serious adverse events
| Measure |
JNS001
n=143 participants at risk
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
n=141 participants at risk
Participants received matching placebo orally once daily for 8 weeks.
|
|---|---|---|
|
Psychiatric disorders
Psychotic disorder
|
0.70%
1/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous tension
|
0.70%
1/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
Other adverse events
| Measure |
JNS001
n=143 participants at risk
Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
|
Placebo
n=141 participants at risk
Participants received matching placebo orally once daily for 8 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
16.8%
24/143 • 9 weeks
|
13.5%
19/141 • 9 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
3/143 • 9 weeks
|
2.1%
3/141 • 9 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
39.9%
57/143 • 9 weeks
|
7.1%
10/141 • 9 weeks
|
|
Psychiatric disorders
Insomnia
|
10.5%
15/143 • 9 weeks
|
9.9%
14/141 • 9 weeks
|
|
Psychiatric disorders
Anxiety
|
4.2%
6/143 • 9 weeks
|
2.1%
3/141 • 9 weeks
|
|
Nervous system disorders
Headache
|
8.4%
12/143 • 9 weeks
|
6.4%
9/141 • 9 weeks
|
|
Nervous system disorders
Dizziness
|
4.2%
6/143 • 9 weeks
|
1.4%
2/141 • 9 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/143 • 9 weeks
|
2.1%
3/141 • 9 weeks
|
|
Nervous system disorders
Tremor
|
2.1%
3/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
Cardiac disorders
Palpitations
|
18.2%
26/143 • 9 weeks
|
1.4%
2/141 • 9 weeks
|
|
Cardiac disorders
Tachycardia
|
5.6%
8/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
Vascular disorders
Hot flush
|
2.8%
4/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
Gastrointestinal disorders
Nausea
|
14.7%
21/143 • 9 weeks
|
2.8%
4/141 • 9 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
6/143 • 9 weeks
|
4.3%
6/141 • 9 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.9%
7/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
5/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
3/143 • 9 weeks
|
0.71%
1/141 • 9 weeks
|
|
Gastrointestinal disorders
Constipation
|
2.8%
4/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
3/143 • 9 weeks
|
0.71%
1/141 • 9 weeks
|
|
General disorders
Thirst
|
14.0%
20/143 • 9 weeks
|
4.3%
6/141 • 9 weeks
|
|
General disorders
Pyrexia
|
4.9%
7/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
General disorders
Malaise
|
4.2%
6/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
General disorders
Chest discomfort
|
2.8%
4/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
Investigations
Weight decreased
|
7.0%
10/143 • 9 weeks
|
0.00%
0/141 • 9 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
2.1%
3/143 • 9 weeks
|
1.4%
2/141 • 9 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/143 • 9 weeks
|
2.1%
3/141 • 9 weeks
|
Additional Information
Medical Director
Janssen Pharm KK Japan
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60