Clinical trial NCT01357993: A Long-Term Study on Safety of JNS001 in Adults With Attention-Deficit Hyperactivity Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention-Deficit / Hyperactivity Disorder
Keywords: Methylphenidate hydrochloride
Concerta
Adults
Attention-Deficit / Hyperactivity Disorder
ADHD
Long term safety
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Throughout the study period (Month 12)
Secondary outcomes:
measure: 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
timeFrame: Baseline to titration visits (Week 1-4) and to months 2-12 or discontinuation
measure: Change in the scores of the CAARS-S: SV from baseline of the preceding study to each visit and to endpoint
timeFrame: Baseline to months 1-12 or discontinuation
measure: 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
timeFrame: Baseline to titration visits (Week 1-4) and to months 2-12 or discontinuation
measure: 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
timeFrame: Baseline to months 1-12 or discontinuation
Other outcomes:
Locations:
city: Chiba
country: Japan
city: Chigasaki
country: Japan
city: Chiyoda
country: Japan
city: Fuchu
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Hamamatsu
country: Japan
city: Higashi-Osaka
country: Japan
city: Ichikawa
country: Japan
city: Iruma
country: Japan
city: Isehara
country: Japan
city: Kashihara
country: Japan
city: Kishiwada
country: Japan
city: Kobe
country: Japan
city: Kumamoto
country: Japan
city: Kurume
country: Japan
city: Matsuyama
country: Japan
city: Nagasaki
country: Japan
city: Nagoya
country: Japan
city: Nara
country: Japan
city: Neyagawa
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Sakai
country: Japan
city: Sapporo
country: Japan
city: Shibuya
country: Japan
city: Takatsuki
country: Japan
city: Tokyo
country: Japan
city: Yokohama
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References: