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

NCT ID: NCT01357993

Last Updated: 2014-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

001

JNS001 18 mg 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks

Group Type: EXPERIMENTAL

JNS001

Intervention Type: DRUG

18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks

Interventions

JNS001

18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks

Intervention Type: DRUG

Eligibility Criteria

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 who completed the preceding study (JNS001-JPN-A01), are considered to be appropriate to continue JNS001 treatment into this extension study by investigator or subinvestigator
• Women of childbearing potential must have a negative urine pregnancy test at the final assessment in the preceding study. If sexually active, continue to use an effective method of birth control throughout the study
• Men must agree to use a double-barrier method of birth control and not donate sperm during the study and for 90 days after receiving the last dose of study drug.

Exclusion Criteria

• Patients who have reported AEs which would prevent transfer to this study from the preceding study (JNS001-JPN-A01)
• Patients who had been judged ineligible as patients for this study by investigator or subinvestigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Shibuya City, , Japan

Takatsuki, , Japan

Tokyo, , Japan

Yokohama, , Japan

Countries

Japan

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1110&filename=CR017758_CSR.pdf

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

Other Identifiers

JNS001-JPN-A02

Identifier Type: OTHER

Identifier Source: secondary_id

CR017758

Identifier Type: -

Identifier Source: org_study_id