An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention-Deficit Hyperactivity Disorder |
Drug: JNS001 Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of JNS001 in Adults With Attention-Deficit/Hyperactivity Disorder at Doses of 18 mg, 36 mg, 54 mg, or 72 mg Per Day |
- Change in DSM-IV Total ADHD Symptoms scores (18 items) of the investigator-rated Conners' Adult ADHD Rating Scale-Observer: Screening Version (CAARS-O: SV) from baseline to the end of the double-blind (DB) phase [ Time Frame: Baseline (Day 0) to the end of the double-blind (DB) phase (ie, Week 8 or early discontinuation in DB phase) ] [ Designated as safety issue: No ]
- Changes from baseline (Day 0) in the scores of the CAARS-S: SV [ Time Frame: Baseline (Day 0) to Week 4 ] [ Designated as safety issue: No ]
- Changes from baseline (Day 0) in the scores of the CAARS-S: SV [ Time Frame: Baseline (Day 0) to Week 6 ] [ Designated as safety issue: No ]
- Changes from baseline (Day 0) in the scores of the CAARS-S: SV [ Time Frame: Baseline (Day 0) to Week 8 ] [ Designated as safety issue: No ]
- Changes from baseline (Day 0) in total score of Q-LES-Q-SF [ Time Frame: Baseline (Day 0) to Week 4 ] [ Designated as safety issue: No ]
- Changes from baseline (Day 0) in total score of Q-LES-Q-SF [ Time Frame: Baseline (Day 0) to Week 6 ] [ Designated as safety issue: No ]
- Changes from baseline (Day 0) in total score of Q-LES-Q-SF [ Time Frame: Baseline (Day 0) to Week 8 ] [ Designated as safety issue: No ]
- Changes from baseline (Day 0) in the scores of the CGI-S at endpoint [ Time Frame: Baseline (Day 0) to the end of the double-blind (DB) phase (ie, Week 8 or early discontinuation in DB phase) ] [ Designated as safety issue: No ]
| Enrollment: | 284 |
| Study Start Date: | March 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
JNS001 18 mg 27 mg and 36 mg tablets (18-72 mg/day) once daily for 8 weeks
|
Drug: JNS001
18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 8 weeks
|
|
Placebo Comparator: 002
Placebo 18 mg 27 mg and 36 mg matching placebo tablets (18-72 mg/day) once daily for 8 weeks
|
Drug: Placebo
18 mg, 27 mg and 36 mg matching placebo tablets (18-72 mg/day) once daily for 8 weeks
|
Detailed Description:
This is a randomized (the study drug is assigned by chance), double-blind (DB, neither physician nor patient knows the name of the assigned drug), multicenter, placebo-controlled, parallel group (each group of patients will be treated at the same time), dose-titration study. This study consists of a screening period, a DB phase (titration period and efficacy assessment period), and post-study phase. The study includes a 1 to 2-week screening period for wash-out of prohibited drugs, and screening for eligibility. Eligible patients will be randomly assigned to receive JNS001 or placebo in a ratio of 1:1. The study also includes a 4-week titration period. Patients will be titrated from a starting dose of 18 mg/day or matching placebo for 7 days (+/- 2 days), and continue with a weekly (+/- 2 days) increment of 18 mg until an individualized dose is achieved. Once an individualized dose is achieved, patients will remain on that dose for the rest of the titration period as far as tolerable. Doses can be tapered down only once during the titration period in the study, and their dose cannot be up-titrated again for the rest of the period. The 4-week titration period will be followed by the 4-week efficacy assessment period. The post-study phase for collection of additional safety data will be scheduled for 1 week after a patient's final study treatment. The study drug will be administered with water once daily in the morning at doses of 18 mg, 36 mg, 54 mg, 72 mg per day or the matching placebo. The study treatment period is 8 weeks (titration period of 4 weeks and efficacy assessment period of 4 weeks).
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations| Japan | |
| Bunkyo, Japan | |
| Chiba, Japan | |
| Chigasaki, Japan | |
| Chiyoda, Japan | |
| Fuchu, Japan | |
| Fukuoka, Japan | |
| Fukushima, Japan | |
| Fukushima N/A, Japan | |
| Hamamatsu, Japan | |
| Higashi-Osaka, Japan | |
| Ichikawa, Japan | |
| Iruma, Japan | |
| Isehara, Japan | |
| Kashihara, Japan | |
| Kishiwada, Japan | |
| Kobe, Japan | |
| Kumamoto, Japan | |
| Kurume, Japan | |
| Matsuyama, Japan | |
| Matsuyama N/A, Japan | |
| Nagasaki, Japan | |
| Nagoya, Japan | |
| Nagoya N/A, Japan | |
| Nara, Japan | |
| Neyagawa, Japan | |
| Osaka, Japan | |
| Saitama, Japan | |
| Sakai, Japan | |
| Sapporo, Japan | |
| Setagaya, Japan | |
| Shibuya, Japan | |
| Takatsuki, Japan | |
| Tokyo, Japan | |
| Yokohama, Japan | |
| Yokohama N/A, Japan | |
| Study Director: | Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. |
More Information
No publications provided
| Responsible Party: | Janssen Pharmaceutical K.K. |
| ClinicalTrials.gov Identifier: | NCT01323192 History of Changes |
| Other Study ID Numbers: | CR017755, JNS001-JPN-A01 |
| Study First Received: | March 10, 2011 |
| Last Updated: | December 24, 2012 |
| Health Authority: | Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center |
Keywords provided by Janssen Pharmaceutical K.K.:
|
Concerta Adults Attention-Deficit/Hyperactivity Disorder ADHD Methylphenidate hydrochloride |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013