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

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).

Study Overview

• Status: Completed
• Conditions: Attention-Deficit / Hyperactivity Disorder
• Intervention / Treatment: Drug: JNS001

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).

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan
  • Chigasaki, Japan
  • Chiyoda, Japan
  • Fuchu, Japan
  • Fukuoka, Japan
  • Fukushima, Japan
  • Hamamatsu, Japan
  • Higashi-Osaka, 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, Japan
  • Takatsuki, Japan
  • Tokyo, Japan
  • Yokohama, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 001; JNS001 18 mg 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks	Drug: JNS001; 18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	Throughout the study period (Month 12)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in DSM-IV Total ADHD symptoms scores (18 items) of the investigator-rated CAARS-O: SV from baseline of the preceding study (JNS001-JPN-A01) to each visit and to endpoint	Baseline to titration visits (Week 1-4) and to months 2-12 or discontinuation
Change in the scores of the CAARS-S: SV from baseline of the preceding study to each visit and to endpoint	Baseline to months 1-12 or discontinuation
Change in the scores of the CGI-S from baseline of the preceding study in the scores of the CGI-S at each visit and endpoint	Baseline to titration visits (Week 1-4) and to months 2-12 or discontinuation
Change in total score of Q-LES-Q-SF from baseline of the preceding study in the scores of the Q-LES-Q-SFat each visit and endpoint	Baseline to months 1-12 or discontinuation

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutical K.K.

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: May 19, 2011
• First Submitted That Met QC Criteria: May 19, 2011
• First Posted (Estimate): May 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 28, 2014
• Last Update Submitted That Met QC Criteria: March 27, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: ADHD; Adults; Concerta; Methylphenidate hydrochloride; Attention-Deficit / Hyperactivity Disorder; Long term safety
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: CR017758; JNS001-JPN-A02 (Other Identifier: Janssen Pharmaceutical K.K., Japan)