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

Attention-Deficit / Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357993
• Other study ID #: CR017758
• Secondary ID: JNS001-JPN-A02
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2011
• Last updated: March 27, 2014
• Start date: May 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2014
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation CenterJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit / Hyperactivity Disorder
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability		Throughout the study period (Month 12)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External 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