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| ID | Type | Description | Link |
|---|---|---|---|
| JNS001-JPN-A01 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The main purpose of this study is to evaluate the efficacy of JNS001 titrated to daily doses of 18 to 72 mg in adults with attention-deficit hyperactivity disorder (ADHD) relative to placebo.
This is a randomized (the study drug is assigned by chance), double-blind (DB, neither physician nor patient knows the name of the assigned drug), multicenter, placebo-controlled, parallel group (each group of patients will be treated at the same time), dose-titration study. This study consists of a screening period, a DB phase (titration period and efficacy assessment period), and post-study phase. The study includes a 1 to 2-week screening period for wash-out of prohibited drugs, and screening for eligibility. Eligible patients will be randomly assigned to receive JNS001 or placebo in a ratio of 1:1. The study also includes a 4-week titration period. Patients will be titrated from a starting dose of 18 mg/day or matching placebo for 7 days (+/- 2 days), and continue with a weekly (+/- 2 days) increment of 18 mg until an individualized dose is achieved. Once an individualized dose is achieved, patients will remain on that dose for the rest of the titration period as far as tolerable. Doses can be tapered down only once during the titration period in the study, and their dose cannot be up-titrated again for the rest of the period. The 4-week titration period will be followed by the 4-week efficacy assessment period. The post-study phase for collection of additional safety data will be scheduled for 1 week after a patient's final study treatment. The study drug will be administered with water once daily in the morning at doses of 18 mg, 36 mg, 54 mg, 72 mg per day or the matching placebo. The study treatment period is 8 weeks (titration period of 4 weeks and efficacy assessment period of 4 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNS001 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNS001 | Drug | Participants will receive JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | Baseline (Day 0) to Endpoint (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba | 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.
The study was conducted at 39 study sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | JNS001 | Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks. |
| FG001 | Placebo | Participants received matching placebo orally once daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Participants will receive matching placebo orally once daily for 8 weeks. |
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| Baseline (Day 0) to Endpoint (Week 8) |
| Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores | 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. | Baseline (Day 0) to Endpoint (Week 8) |
| Clinical Global Impression of Change (CGI-C) Scores | 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. | Endpoint (Week 8) |
| 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 | 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. | Baseline (Day 0) to Endpoint (Week 8) |
| Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores | 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. | Baseline (Day 0) to Endpoint (Week 8) |
| Chigasaki |
| Japan |
| Chiyoda City | Japan |
| Fuchū | Japan |
| Fukuoka | Japan |
| Fukushima | Japan |
| Hamamatsu | Japan |
| Higashiosaka | Japan |
| Ichikawa | Japan |
| Iruma | Japan |
| Isehara | Japan |
| Kashihara | Japan |
| Kishiwada | Japan |
| Kobe | Japan |
| Kumamoto | Japan |
| Kurume | Japan |
| Matsuyama | Japan |
| Nagasaki | Japan |
| Nagoya | Japan |
| Nara | Japan |
| Neyagawa | Japan |
| Osaka | Japan |
| Saitama | Japan |
| Sakai | Japan |
| Sapporo | Japan |
| Setagaya City | Japan |
| Shibuya City | Japan |
| Takatsuki | Japan |
| Tokyo | Japan |
| Yokohama | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | JNS001 | Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks. |
| BG001 | Placebo | Participants received matching placebo orally once daily for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 0) to Endpoint (Week 8) |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 0) to Endpoint (Week 8) |
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| Secondary | Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores | 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. | 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. | Posted | Median | Full Range | Scores on a scale | Baseline (Day 0) to Endpoint (Week 8) |
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| Secondary | Clinical Global Impression of Change (CGI-C) Scores | 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. | 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. | Posted | Median | Full Range | Scores on a scale | Endpoint (Week 8) |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 0) to Endpoint (Week 8) |
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| Secondary | Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 0) to Endpoint (Week 8) |
|
9 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JNS001 | Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks. | 2 | 143 | 117 | 143 | ||
| EG001 | Placebo | Participants received matching placebo orally once daily for 8 weeks. | 0 | 141 | 76 | 141 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychotic disorder | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Pneumothorax spontaneous tension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Thirst | General disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA Version 15.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA Version 15.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA Version 15.0 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA Version 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Janssen Pharm KK Japan | +81-3-4411-5509 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Title | Measurements |
|---|---|
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| 36-49 years of age |
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| 50-64 years of age |
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| Male |
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| Other |
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