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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00566449
First received: November 29, 2007
Last updated: April 24, 2014
Last verified: April 2014

November 29, 2007
April 24, 2014
December 2007
July 2008   (final data collection date for primary outcome measure)
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 ]
The primary study objective is to evaluate the safety and effectiveness of JNJ- 31001074 in adult patients with ADHD.
Complete list of historical versions of study NCT00566449 on ClinicalTrials.gov Archive Site
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 ]
The secondary study objective is to assess drug levels in adults with ADHD after taking JNJ-31001074.
Not Provided
Not Provided
 
A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: Placebo
    one dose daily for 4 weeks
  • Drug: JNJ-31001074
    10 mg daily for 4 weeks
  • Drug: JNJ-31001074
    30 mg daily for 4 weeks
  • Experimental: 001
    JNJ-31001074 10 mg daily for 4 weeks
    Intervention: Drug: JNJ-31001074
  • Placebo Comparator: 003
    Placebo one dose daily for 4 weeks
    Intervention: Drug: Placebo
  • Experimental: 002
    JNJ-31001074 30 mg daily for 4 weeks
    Intervention: Drug: JNJ-31001074
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00566449
CR014608, C-2007-008
No
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
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.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP