Clinical trial NCT00566449: A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
ADHD
JNJ-31001074
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2007-12-03
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary study objective is to evaluate the safety and effectiveness of JNJ- 31001074 in adult patients with ADHD.
timeFrame: 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:
measure: The secondary study objective is to assess drug levels in adults with ADHD after taking JNJ-31001074.
timeFrame: 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.
Other outcomes:
Locations:
city: Irvine
country: United States
state: California
city: Lafayette
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Eagle
country: United States
state: Idaho
city: Libertyville
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: Farmington
country: United States
state: Michigan
city: Chapel Hll
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Media
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Herndon
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: ALZA
name: Alza Corporation Clinical Trial
role: STUDY_DIRECTOR
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: