| ID | Type | Description | Link |
|---|---|---|---|
| C-2007-008 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | JNJ-31001074 10 mg daily for 4 weeks |
|
| 003 | Placebo Comparator | Placebo one dose daily for 4 weeks |
|
| 002 | Experimental | JNJ-31001074 30 mg daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | one dose daily for 4 weeks |
| |
| JNJ-31001074 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irvine | California | United States | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
10 mg daily for 4 weeks |
|
| JNJ-31001074 | Drug | 30 mg daily for 4 weeks |
|
| Lafayette |
| California |
| United States |
| San Francisco | California | United States |
| Bradenton | Florida | United States |
| Fort Myers | Florida | United States |
| Orlando | Florida | United States |
| South Miami | Florida | United States |
| Eagle | Idaho | United States |
| Libertyville | Illinois | United States |
| Overland Park | Kansas | United States |
| Boston | Massachusetts | United States |
| Farmington | Michigan | United States |
| Chapel Hll | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Dayton | Ohio | United States |
| Portland | Oregon | United States |
| Media | Pennsylvania | United States |
| Austin | Texas | United States |
| Houston | Texas | United States |
| Herndon | Virginia | United States |
| Seattle | Washington | United States |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C574166 | bavisant |
Not provided
Not provided
Not provided