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| ID | Type | Description | Link |
|---|---|---|---|
| JNS001-JPN-A02 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The main purpose of this study is to evaluate long-term safety and tolerability of JNS001 at 18 to 72 mg per day in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
This is a multicenter, open-label (all people involved know the identity of the intervention), dose-titration (to adjust the dose of a drug until optimal result is reached), long-term safety study in adult patients with a diagnosis of ADHD. The study consists of the Long-term phase (4-week titration period and 44-week maintenance period) and the 1-week Post-study phase. The 4 week-titration period is to find the individualized dose for each patient regardless of the treatments in the preceding study (JNS001-JPN-A01). Patients will be titrated from a starting dose of 18 mg/day for 7 days, and continue with a weekly (+/- 2 days) increment of 9 or 18 mg until an individualized dose is achieved. The titration period will be followed by a 44-week maintenance period which has combined 48-week (1-year) treatment duration with the titration period. During the maintenance period, the dose will be adjusted between 18 to 72 mg depending on the patients' symptoms. In the post-study phase, safety information will be collected after the last dose of the study treatment or premature discontinuation. The study drug will be administered with water once daily in the morning at doses of 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, or 72 mg per day. The study treatment period is 48 weeks (titration period of 4 weeks and maintenance period of 44 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | JNS001 18 mg 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNS001 | Drug | 18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | Throughout the study period (Month 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in DSM-IV Total ADHD symptoms scores (18 items) of the investigator-rated CAARS-O: SV from baseline of the preceding study (JNS001-JPN-A01) to each visit and to endpoint | Baseline to titration visits (Week 1-4) and to months 2-12 or discontinuation | |
| Change in the scores of the CAARS-S: SV from baseline of the preceding study to each visit and to endpoint |
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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 | |||||
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| Label | URL |
|---|---|
| An Open-Label, Dose-Titration, Long-Term Study to Evaluate the Safety of JNS001 in Adults with Attention-Deficit/Hyperactivity Disorder at Doses of 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg or 72 mg per day | View source |
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| Baseline to months 1-12 or discontinuation |
| Change in the scores of the CGI-S from baseline of the preceding study in the scores of the CGI-S at each visit and endpoint | Baseline to titration visits (Week 1-4) and to months 2-12 or discontinuation |
| Change in total score of Q-LES-Q-SF from baseline of the preceding study in the scores of the Q-LES-Q-SFat each visit and endpoint | Baseline to months 1-12 or discontinuation |
| 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 |
| Shibuya City | Japan |
| Takatsuki | Japan |
| Tokyo | Japan |
| Yokohama | Japan |
| 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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