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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01357993
First received: May 19, 2011
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Attention-Deficit / Hyperactivity Disorder
Drug: JNS001
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Throughout the study period (Month 12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Baseline to titration visits (Week 1-4) and to months 2-12 or discontinuation ] [ Designated as safety issue: No ]
  • Change in the scores of the CAARS-S: SV from baseline of the preceding study to each visit and to endpoint [ Time Frame: Baseline to months 1-12 or discontinuation ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline to titration visits (Week 1-4) and to months 2-12 or discontinuation ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline to months 1-12 or discontinuation ] [ Designated as safety issue: No ]

Enrollment: 253
Study Start Date: May 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (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 48 weeks
Drug: JNS001
18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357993

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
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01357993     History of Changes
Other Study ID Numbers: CR017758, JNS001-JPN-A02
Study First Received: May 19, 2011
Last Updated: March 27, 2014
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Methylphenidate hydrochloride
Concerta
Adults
Attention-Deficit / Hyperactivity Disorder
ADHD
Long term safety

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 April 15, 2014