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| ID | Type | Description | Link |
|---|---|---|---|
| 31001074ATT2001 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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The purpose of this study is to evaluate the efficacy and safety/tolerability of 3 different dosages of JNJ-31001074 compared with placebo in adult patients with attention-deficit/hyperactivity disorder (ADHD).
This will be a randomized (study drug assigned by chance), double-blind (neither the investigator nor the patient know the name of the assigned study drug), placebo- and active-controlled, parallel-group, multicenter study in patients with adult ADHD. The study population will include approximately 426 male and female patients, 18 to 55 years of age (inclusive) with a DSM-IV diagnosis of ADHD, who will be randomly assigned (like flipping a coin) in a 1:1:1:1:1:1 ratio to 1 of 6 treatment groups (1 milligrams per day [mg/d] JNJ-31001074, 3 mg/d JNJ-31001074, 10 mg/d JNJ 31001074, 80 mg/d atomoxetine HCl, 54 mg/d controlled-release [OROS] methylphenidate HCl, or placebo). Study centers will make every attempt to include approximately 4 women for every 10 men randomized. The study will consist of 3 phases: a screening phase of up to 7 days; a 42-day double-blind treatment phase; and a 7-day post-treatment phase, in which the investigator staff will call patients 7 days after the last dose of study drug, to ask about any adverse events. The total duration of patient participation will be approximately 8 weeks. During the screening and double-blind treatment phases, patients will have periodic assessments at visits (screening, Day 1, Day 4, Day 7, Day 14, Day 28, and Day 42) of the following: severity of ADHD symptoms, including inattention and impulsivity; daily function; sleep experience; and cigarette consumption and cigarette craving. In addition, patients will be asked to include an adult household member to complete the observer version of the Conners Adult ADHD Rating Scale (CAARS-O:SV) at the beginning and end of the study. Patients will take one oral capsules each day in the morning upon awakening, either JNJ-31001074 (1, 3, or 10 mg), matching atomoxetine HCL (40 or 80 mg), matching OROS methylphenidate HCl (36 or 54 mg), or matching placebo. For atomoxetine HCl, patients will receive 40 mg/d for the first 3 days, and 80 mg/d for the remainder of the study. For OROS methylphenidate HCl, patients will receive 36 mg/d for the first 3 days, and 54 mg/d for the remainder of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | JNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days |
|
| 002 | Experimental | JNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days |
|
| 003 | Experimental | JNJ-31001074 10 mg/d 10-mg capsule once daily for 42 days |
|
| 004 | Active Comparator | Atomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days |
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| 005 | Active Comparator | OROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days |
|
| 006 | Placebo Comparator | Placebo capsule once daily for 42 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine 80 mg/d | Drug | 40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the ADHD rating scale total score | Through Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints will include Clinical Global Impression of Change (CGI-C). | At the end of the double-blind treatment phase (Day 42) | |
| Other secondary endpoints will include the change from baseline in the Conners Adult ADHD Rating Scale (CAARS-S:SV) and the Clinical Global Impression - Severity (CGI-S). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22519922 | Derived | Weisler RH, Pandina GJ, Daly EJ, Cooper K, Gassmann-Mayer C; 31001074-ATT2001 Study Investigators. Randomized clinical study of a histamine H3 receptor antagonist for the treatment of adults with attention-deficit hyperactivity disorder. CNS Drugs. 2012 May 1;26(5):421-34. doi: 10.2165/11631990-000000000-00000. |
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| Placebo | Drug | Placebo capsule once daily for 42 days |
|
| OROS methylphenidate HCl 54 mg/d | Drug | 36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days |
|
| JNJ-31001074 3 mg/d | Drug | 3-mg capsule once daily for 42 days |
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| JNJ-31001074 1 mg/d | Drug | 1-mg capsule once daily for 42 days |
|
| JNJ-31001074 10 mg/d | Drug | 10-mg capsule once daily for 42 days |
|
| Through the end of the double-blind treatment phase (Day 42) |
| Lafayette |
| California |
| United States |
| Los Alamitos | California | United States |
| Santa Ana | California | United States |
| Wildomar | California | United States |
| Bradenton | Florida | United States |
| Jacksonville | Florida | United States |
| North Miami | Florida | United States |
| Orlando | Florida | United States |
| South Miami | Florida | United States |
| St. Petersburg | Florida | United States |
| Atlanta | Georgia | United States |
| Boise | Idaho | United States |
| Eagle | Idaho | United States |
| Libertyville | Illinois | United States |
| Overland Park | Kansas | United States |
| Prairie Village | Kansas | United States |
| Rochester Hills | Michigan | United States |
| Saint Charles | Missouri | United States |
| Mount Kisco | New York | United States |
| New York | New York | United States |
| Raleigh | North Carolina | United States |
| Dayton | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Eugene | Oregon | United States |
| Portland | Oregon | United States |
| Media | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Memphis | Tennessee | United States |
| Austin | Texas | United States |
| Wharton | Texas | United States |
| Burlington | Vermont | United States |
| Herndon | Virginia | United States |
| Seattle | Washington | United States |
| Middleton | Wisconsin | 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 |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| C574166 | bavisant |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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