NCT00566449

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of JNJ-31001074 compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 13, 2014

Status Verified

April 1, 2014

Enrollment Period

7 months

First QC Date

November 29, 2007

Last Update Submit

April 24, 2014

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity DisorderADHDJNJ-31001074

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • 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.

Study Arms (3)

001

EXPERIMENTAL

JNJ-31001074 10 mg daily for 4 weeks

Drug: JNJ-31001074

003

PLACEBO COMPARATOR

Placebo one dose daily for 4 weeks

Drug: Placebo

002

EXPERIMENTAL

JNJ-31001074 30 mg daily for 4 weeks

Drug: JNJ-31001074

Interventions

PlaceboDRUG

one dose daily for 4 weeks

003
JNJ-31001074DRUG

10 mg daily for 4 weeks

001

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 and for 3 months afterwards

You may not qualify if:

  • Any psychiatric condition including acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social personality disorder or borderline personality disorder
  • Autism, asperger's syndrome, mental retardation
  • Presence of motor tics, history of Tourette's syndrome or family history of Tourette's syndrome
  • History of substance use/abuse disorder or eating disorder
  • History of myocardial infarction, stroke, glaucoma, seizures, hypertension, heart rhythm abnormalities or color blindness
  • Use of prescription medication or herbal supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Irvine, California, United States

Location

Unknown Facility

Lafayette, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Fort Myers, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

South Miami, Florida, United States

Location

Unknown Facility

Eagle, Idaho, United States

Location

Unknown Facility

Libertyville, Illinois, United States

Location

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Farmington, Michigan, United States

Location

Unknown Facility

Chapel Hll, North Carolina, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Dayton, Ohio, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Media, Pennsylvania, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Herndon, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

bavisant

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Alza Corporation Clinical Trial

    ALZA

    STUDY DIRECTOR

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2007

First Posted

December 3, 2007

Study Start

December 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

May 13, 2014

Record last verified: 2014-04

Locations

US(21)