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Study is to assess if TC-5619 improves symptoms for adults diagnosed with the inattentive-predominant subtype of ADHD over a 4-week treatment period.
A 3-arm, double-blind, randomized, placebo-controlled, multicenter, fixed dose study to assess efficacy and safety of TC-5619 in adults with inattentive-predominant attention deficit/hyperactivity disorder (ADHD) utilizing the Connor's Adult ADHD Rating Scale-Investigator Completed Version (CAARS-INV) inattentive subscale scores through 4 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TC-5619-238 (25mg) | Experimental | TC-5619-238 25 mg will be provided as hard gelatin capsules |
|
| Placebo | Placebo Comparator | Placebo will be provided as hard gelatin capsules similar to TC-5619-238 |
|
| TC-5619-238 (5 mg) | Experimental | TC-5619-238 5 mg will be provided as hard gelatin capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TC-5619-238 5mg | Drug | TC-5619-238 5mg capsule taken once daily for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV) | Scores on the inattentive subscale of the CAARS-INV obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Conner's Adult ADHD-Investigator Version total score | Scores on the total CAARS-INV obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo). | 4 weeks |
| Conner's Adult ADHD Rating Scale-Subject Self-Rating Version (CAARS-S) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Wilens, MD | Clinical Trials Network & Institute, Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwestern Research, Inc | Beverly Hills | California | 90210 | United States | ||
| Synergy Clinical Research Center |
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| TC-5619-238 25mg |
| Drug |
TC-5619-238 25mg capsules taken once daily for 4 weeks |
|
| Placebo | Drug | Placebo capsules will be taken once daily for 4 weeks |
|
Scores on the CAARS-S obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo). |
| 4 weeks |
| National City |
| California |
| 91920 |
| United States |
| MCB Clinical Research Centers, LLC | Colorado Springs | Colorado | 80910 | United States |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32216 | United States |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | United States |
| Compass Research, Inc. | Orlando | Florida | 32806 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Clinical Trials Network & Institute, Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Neuro-Behavioral Clinical Reseach, Inc. | Canton | Ohio | 44718 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| CNS Healthcare | Memphis | Tennessee | 38119 | United States |
| FutureSearch Clinical Trials, LP | Austin | Texas | 78731 | 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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