A Phase 2 interventional study of Placebo and JNJ-31001074 in Attention Deficit Hyperactivity Disorder, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed at 21 sites in United States. Open to male participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-05-13.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 2, Interventional, and Treatment
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 32 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
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Exclusion Criteria:
JNJ-31001074 10 mg daily for 4 weeks
Drug: JNJ-31001074
Placebo one dose daily for 4 weeks
Drug: Placebo
JNJ-31001074 30 mg daily for 4 weeks
Drug: JNJ-31001074
one dose daily for 4 weeks
10 mg daily for 4 weeks
30 mg daily for 4 weeks
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.
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.
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.