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JNJ-31001074

Phase 2

Attention Deficit Hyperactivity Disorder | Small molecule | Other |Johnson & Johnson|Last Updated: May 13, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment68
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00566449A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.PHASE2 COMPLETED 32 — — Dec 1, 2007Jul 1, 2008May 13, 201421 United States
NCT00890240A Study to Evaluate Pharmacokinetics, Safety and Tolerability After a Single Dose Administration of of JNJ-31001074 in Children (6-11 Years) With Attention Deficit Hyperactivity Disorder (ADHD)PHASE1 COMPLETED 18 — — May 1, 2009Nov 1, 2009Apr 16, 2010 - —
NCT00890292A Study to Evaluate Pharmacokinetics, Safety and Tolerability After a Single Dose Administration of JNJ-31001074 in Pediatric Patients (12-17 Years) With Attention Deficit Hyperactivity Disorder (ADHD)PHASE1 COMPLETED 18 — — May 1, 2009Dec 1, 2009Apr 16, 2010 - —
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Study Endpoints
Primary Endpoints
The primary study objective is to evaluate the safety and effectiveness of JNJ- 31001074 in adult patients with ADHD.
ADHD assessments, vital signs, laboratory tests and ECGs will be collected 7 times during the study; at screening, baseline and 5 weekly visit. Adverse events will be collected throughout the study.
The objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of JNJ-31001074 after a single dose administration of JNJ-31001074 in pediatric patients with ADHD, 6 to 11 years of age, inclusive.
3 days of blood and urine sampling
The objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of JNJ-31001074 after a single dose administration of JNJ-31001074 in pediatric patients with ADHD, 12 to 17 years of age, inclusive.
3 days of blood and urine sampling
Secondary Endpoints
The secondary study objective is to assess drug levels in adults with ADHD after taking JNJ-31001074.
Samples to measure drug levels in the blood will be collected three times at baseline and termination visits and once at visits done at Weeks 1, 2, and 3.
Incidence and type of adverse events and changes in clinical laboratory results, electrocardiograms(ECGs),physical examination,vital signs,Clinical Global Impression of Severity of Illness(CGI-S) scale and Columbia-Suicide Severity Rating Scale (C-SSRS)
24 days (includes a 21 day screening phase and a 3-day open-label treatment phase
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
001EXPERIMENTALJNJ-31001074 10 mg daily for 4 weeks
003PLACEBO_COMPARATORPlacebo one dose daily for 4 weeks
002EXPERIMENTALJNJ-31001074 30 mg daily for 4 weeks
Interventions
NameTypeDescription
PlaceboDRUGone dose daily for 4 weeks
JNJ-31001074DRUG10 mg daily for 4 weeks
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Eligibility Criteria
Age Range18 Years — 64 Years
SexMALE
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Diagnosis of attention deficit hyperactivity disorder with symptoms from age 7 * In good general health * Willing to not take any other ADHD medication or start any behaviorial modification programs during the study * Willing to use approved birth control throughout the study ...

Countries:United States
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