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JNS001

Phase 3

Attention-Deficit / Hyperactivity Disorder | Small molecule | Other |Johnson & Johnson|Last Updated: Mar 28, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment253
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01357993A Long-Term Study on Safety of JNS001 in Adults With Attention-Deficit Hyperactivity DisorderPHASE3 COMPLETED 253 — — May 1, 2011Mar 1, 2013Mar 28, 201429 Japan
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Throughout the study period (Month 12)
Secondary Endpoints
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
001EXPERIMENTALJNS001 18 mg 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks
Interventions
NameTypeDescription
JNS001DRUG18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites29

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...

Countries:Japan
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