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

NCT01357993 | Completed Phase 3

• 2 other identifiers: CR017758JNS001-JPN-A02
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 29

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).

Conditions

Attention-Deficit / Hyperactivity Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Throughout the study period (Month 12)

Secondary Outcomes (4)

• 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

Study Arms (1)

001

EXPERIMENTAL

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

Drug: JNS001

Interventions

JNS001 DRUG

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

001

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (29)

Unknown Facility

Chiba, Japan

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Chigasaki, Japan

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Chiyoda City, Japan

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Fuchū, Japan

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Fukuoka, Japan

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Fukushima, Japan

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Hamamatsu, Japan

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Higashiosaka, Japan

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Ichikawa, Japan

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Iruma, Japan

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Isehara, Japan

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Kashihara, Japan

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Kishiwada, Japan

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Kobe, Japan

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Kumamoto, Japan

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Kurume, Japan

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Matsuyama, Japan

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Nagasaki, Japan

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Nagoya, Japan

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Nara, Japan

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Neyagawa, Japan

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Osaka, Japan

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Saitama, Japan

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Sakai, Japan

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Sapporo, Japan

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Shibuya City, Japan

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Takatsuki, Japan

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Tokyo, Japan

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Yokohama, Japan

Location

Related 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

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

JP (29)