An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder

NCT ID: NCT01323192

Last Updated: 2013-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-04-30

Brief 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.

Detailed Description

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).

Conditions

Attention-Deficit Hyperactivity Disorder

Keywords

Concerta; Adults; Attention-Deficit/Hyperactivity Disorder; ADHD; Methylphenidate hydrochloride

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

JNS001

Group Type: EXPERIMENTAL

JNS001

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

JNS001

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who meet the criteria of ADHD (predominantly inattentive type [314.00], predominantly hyperactive-impulsive type [314.01], and combined type [314.01]) of DSM-IV-TR both at present and in childhood, based on Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) at screening
• DSM-IV Total ADHD Symptoms scores (18 items) of CAARS-O: SV score of = 24 as determined by investigator or co-investigator at baseline
• Healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG and clinical laboratory tests performed at screening
• Women of childbearing potential must have a negative urine pregnancy test at screening
• Patients (and their legally-acceptable representative if patients are 18 or 19 years of age) 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.

Exclusion Criteria

• Presence or history of co-morbid psychiatric diagnosis per DSM-IV-TR criteria of bipolar I disorder, schizophrenia, schizoaffective disorder, or severe obsessive compulsive disorders
• Presence of co-morbid psychiatric diagnosis per DSM-IV-TR criteria of pervasive developmental disorder (including autistic disorder or Asperger's disorder), suicidality, or any other diagnosis that in the judgment the investigator or co-investigator would exclude the patient from the study
• Presence of motor tics, history of Tourette's disorder, or family history of Tourette's disorder
• Known or suspected mental retardation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Chiba, , Japan

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

Countries

Japan

Other Identifiers

JNS001-JPN-A01

Identifier Type: OTHER

Identifier Source: secondary_id

CR017755

Identifier Type: -

Identifier Source: org_study_id