ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.

This study has been completed.

Sponsored by: 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: JNJ-31001074
Drug: Placebo
Phase II

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:   144
Study Start Date:   December 2007
Study Completion Date:   July 2008

Arms Assigned Interventions
001: Experimental Drug: JNJ-31001074
10 mg daily for 4 weeks
002: Experimental Drug: JNJ-31001074
30 mg daily for 4 weeks
003: Placebo Comparator Drug: Placebo
one dose 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 takng 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:     Alza Corporation Clinical Trial     Alza Corporation, DE, USA    
  More Information


Responsible Party:   Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Director Clinical Research )
Study ID Numbers:   CR014608, C-2007-008
First Received:   November 29, 2007
Last Updated:   October 1, 2008
ClinicalTrials.gov Identifier:   NCT00566449
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  

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on October 03, 2008




Links to all studies - primarily for crawlers