NCT01357993

A Long-Term Study on Safety of JNS001 in Adults With Attention-Deficit Hyperactivity Disorder

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Attention-Deficit / Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	JNS001	18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-05-23
• Last updated: 2014-03-28

Locations

29 sites across 1 country: Japan