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JNJ-31001074

Phase 2

Attention Deficit Hyperactivity Disorder | Small molecule | Psychiatry |Johnson & Johnson|Trials Updated: May 13, 2014

JNJ-31001074 development status

Highest phase Phase 2
Registered trials 6 across 2 sponsors since Dec 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment68

FDA Designations

No designations recorded

JNJ-31001074 clinical trials

JNJ-31001074 · 3 trials · 2 indications

Phase 2 1Phase 1 2
NCT00566449A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.Attention Deficit Hyperactivity Disorder
COMPLETED32 Analytics
PHASE2COMPLETED
A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.
Attention Deficit Hyperactivity DisorderUnlock trial analytics

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 to 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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Frequently asked questions about JNJ-31001074

What is JNJ-31001074?

JNJ-31001074 is an investigational small molecule developed by Johnson & Johnson for Attention Deficit Hyperactivity Disorder (ADHD). It has been studied in pediatric, child, and adult ADHD populations across three completed clinical trials. It is not an approved medicine and remains in clinical development.

What is JNJ-31001074 used for in ADHD?

JNJ-31001074 was studied as a treatment for Attention Deficit Hyperactivity Disorder. Trials enrolled children aged 6 to 11, pediatric patients aged 12 to 17, and adults aged 18 and older with ADHD. All three studies are completed, and the drug is investigational rather than approved for prescribing.

Who makes JNJ-31001074?

Johnson & Johnson, which trades under the ticker JNJ, is the developer of JNJ-31001074. The company sponsored the clinical program evaluating the compound in ADHD, including pharmacokinetic, safety, tolerability, and effectiveness studies in children, adolescents, and adults.

What phase is JNJ-31001074 in?

JNJ-31001074 has reached Phase 2. The Phase 2 study was a placebo-controlled, randomized, double-blind safety and effectiveness trial in adults with ADHD. Two earlier Phase 1 studies evaluated pharmacokinetics, safety, and tolerability after single-dose administration in children and pediatric patients.

What clinical trials is JNJ-31001074 in?

Three completed trials have studied JNJ-31001074: NCT00890292 in pediatric patients aged 12 to 17, NCT00890240 in children aged 6 to 11, and NCT00566449, a Phase 2 safety and effectiveness study in adults with ADHD conducted in the United States. Total enrollment across the program was 68 participants.