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

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00566449

Purpose

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	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Placebo Drug: JNJ-31001074	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	December 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566449

Sponsors and Collaborators

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

Investigators

Study Director:

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

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

More Information

No publications provided

Responsible Party:	Director Clinical Research, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00566449 History of Changes
Obsolete Identifiers:	NCT00767078
Other Study ID Numbers:	CR014608, C-2007-008
Study First Received:	November 29, 2007
Last Updated:	June 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Attention Deficit Hyperactivity Disorder
ADHD
JNJ-31001074

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012