CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 284 enrolled
Drug / intervention
JNS001 +1 moredrug
Likely dose
JNS001 18 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01323192
NCT01323192Phase 3Completed

A Double-blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of JNS001 in Adults With Attention-Deficit/Hyperactivity Disorder at Doses of 18 mg, 36 mg, 54 mg, or 72 mg Per Day

Janssen Pharmaceutical K.K.·interventional·Posted Mar 25, 2011·Updated Sep 6, 2013

In Brief

A Phase 3 clinical trial evaluating JNS001 and Placebo for Attention-Deficit Hyperactivity Disorder. Completed, enrolled 284 participants across 30 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2011
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.3 years ago

Interventions

JNS001drug

Participants will receive JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.

Placebodrug

Participants will receive matching placebo orally once daily for 8 weeks.