A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.
April 24, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Investigate the Safety and Efficacy of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is being done to assess safety and tolerability and to explore the effectiveness of a new, experimental drug in the treatment of attention deficit hyperactivity disorder in adults.
Approximately 144 adult patients with ADHD will be recruited for the study.
Patients who meet study criteria will need to stop taking any ADHD medications they are currently using.
They will be randomly assigned to one of 3 treatment arms; each patient has an equal chance of receiving 10 mg JNJ-31001017, 30 mg JNJ-31001074, or placebo.
Placebo has no active drug.
This is a blinded study, i.e. the patient, the study doctor and the study sponsor will not know what treatment the patient receives until all patients complete the study.
Patients will be dispensed a bottle containing study drug for the upcoming week at 4 of the study visits.
The study doctor and the sponsor will monitor the study for the occurrence of possible side effects.
In addition to a screening visit, patients will return weekly for 6 additional study visits including an end of study visit and a follow-up visit.
Patients will take study drug for a total of 4 weeks.
After completing the study, patients may resume other ADHD medications.
Medical and ADHD history, physical examination, blood pressure, heart rate, temperature, weight and ECGs will be checked periodically throughout the study.
Blood samples will be taken for standard safety laboratory tests as well as for the measurement of the drug blood level.
Questionnaires relating to ADHD and cognitive testing will be administered throughout the study.
Each day for four weeks, patients will take orally, at least one hour before eating in the morning, 1 tablet containing either 10 mg JNJ-31001074, 30 mg JNJ-31001074 or placebo.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Irvine, California, United States
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Lafayette, California, United States
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San Francisco, California, United States
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Florida
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Bradenton, Florida, United States
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Fort Myers, Florida, United States
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Orlando, Florida, United States
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South Miami, Florida, United States
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Idaho
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Eagle, Idaho, United States
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Illinois
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Libertyville, Illinois, United States
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Kansas
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Overland Park, Kansas, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Farmington, Michigan, United States
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North Carolina
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Chapel Hll, North Carolina, United States
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Raleigh, North Carolina, United States
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Ohio
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Dayton, Ohio, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Media, Pennsylvania, United States
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Texas
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Austin, Texas, United States
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Houston, Texas, United States
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Virginia
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Herndon, Virginia, United States
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Washington
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Seattle, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 and for 3 months afterwards
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 001
JNJ-31001074 10 mg daily for 4 weeks
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10 mg daily for 4 weeks
30 mg daily for 4 weeks
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Placebo Comparator: 003
Placebo one dose daily for 4 weeks
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one dose daily for 4 weeks
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Experimental: 002
JNJ-31001074 30 mg daily for 4 weeks
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10 mg daily for 4 weeks
30 mg daily for 4 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary study objective is to evaluate the safety and effectiveness of JNJ- 31001074 in adult patients with ADHD.
Time Frame: 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.
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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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The secondary study objective is to assess drug levels in adults with ADHD after taking JNJ-31001074.
Time Frame: 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.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
November 29, 2007
First Submitted That Met QC Criteria
November 29, 2007
First Posted (Estimate)
December 3, 2007
Study Record Updates
Last Update Posted (Estimate)
May 13, 2014
Last Update Submitted That Met QC Criteria
April 24, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR014608
- C-2007-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.