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JNS001 · 2 trials · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | JNS001 18 mg 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks |
| JNS001 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| JNS001 | DRUG | 18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks |
| Placebo | DRUG | Participants will receive matching placebo orally once daily for 8 weeks. |
Inclusion Criteria: * Patients (and their legally-acceptable representative if patients are 18 or 19 years old) must have signed an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study * Patients...
JNS001 is being developed for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults. It is a small molecule therapeutic candidate studied in the psychiatry therapeutic area. The clinical program has focused on adult patients aged 18 years and older.
JNS001 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. The company has sponsored the clinical development program for this ADHD candidate.
JNS001 is in Phase 3 clinical development. Two Phase 3 trials have been completed, and no trials are currently active. The drug is investigational and has not been approved by regulatory authorities for any indication.
JNS001 has been evaluated in two completed Phase 3 trials: NCT01357993, a long-term safety study in adults with ADHD, and NCT01323192, an efficacy and safety study in adults with ADHD. Both trials were conducted in Japan and together enrolled 537 patients.
Both Phase 3 trials of JNS001 were randomized, double-blind, and placebo-controlled. They enrolled adults aged 18 years and older with ADHD in Japan. NCT01357993 enrolled 253 patients for long-term safety, and NCT01323192 enrolled 284 patients for efficacy and safety.