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

NCT01323192 | Completed Phase 3 Results

• 2 other identifiers: CR017755JNS001-JPN-A01
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 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.

Conditions

Attention-Deficit Hyperactivity Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Endpoint in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Scores of Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV)

  CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.

  Baseline (Day 0) to Endpoint (Week 8)

Secondary Outcomes (5)

• Mean Change From Baseline to Endpoint in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) Total Score Other Than Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Score

  Baseline (Day 0) to Endpoint (Week 8)

• Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores

  Baseline (Day 0) to Endpoint (Week 8)

• Clinical Global Impression of Change (CGI-C) Scores

  Endpoint (Week 8)

• Mean Change From Baseline to Endpoint in the Conners' Adult Attention Deficit-Hyperactivity Disorder (ADHD) Rating Scales-Self Report: Screening Version (CAARS-S:SV) Score

  Baseline (Day 0) to Endpoint (Week 8)

• Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores

  Baseline (Day 0) to Endpoint (Week 8)

Study Arms (2)

JNS001

EXPERIMENTAL

Drug: JNS001

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JNS001 DRUG

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

JNS001

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (30)

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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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Setagaya City, 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

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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director
• Organization: Janssen Pharm KK Japan

+81-3-4411-5509

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 25, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 6, 2013
• Results First Posted: September 6, 2013

Record last verified: 2013-06

Locations

JP (30)