A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00566449

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Drug: Placebo Drug: JNJ-31001074 Drug: JNJ-31001074	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 JNJ-31001074 10 mg daily for 4 weeks	Drug: JNJ-31001074 10 mg daily for 4 weeks
Placebo Comparator: 003 Placebo one dose daily for 4 weeks	Drug: Placebo one dose daily for 4 weeks
Experimental: 002 JNJ-31001074 30 mg daily for 4 weeks	Drug: JNJ-31001074 30 mg daily for 4 weeks

Arm

Intervention/Treatment

Experimental: 001

JNJ-31001074 10 mg daily for 4 weeks

Drug: JNJ-31001074

10 mg daily for 4 weeks

Placebo Comparator: 003

Placebo one dose daily for 4 weeks

Drug: Placebo

one dose daily for 4 weeks

Experimental: 002

JNJ-31001074 30 mg daily for 4 weeks

Drug: JNJ-31001074

30 mg daily for 4 weeks

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Irvine	California	United States
2	Lafayette	California	United States
3	San Francisco	California	United States
4	Bradenton	Florida	United States
5	Fort Myers	Florida	United States
6	Orlando	Florida	United States
7	South Miami	Florida	United States
8	Eagle	Idaho	United States
9	Libertyville	Illinois	United States
10	Overland Park	Kansas	United States
11	Boston	Massachusetts	United States
12	Farmington	Michigan	United States
13	Chapel Hll	North Carolina	United States
14	Raleigh	North Carolina	United States
15	Dayton	Ohio	United States
16	Portland	Oregon	United States
17	Media	Pennsylvania	United States
18	Austin	Texas	United States
19	Houston	Texas	United States
20	Herndon	Virginia	United States
21	Seattle	Washington	United States

Sponsors and Collaborators

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

Investigators

Study Director: 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.