Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen by Timothy Wilens, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Targacept Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Timothy Wilens, MD

Principal Investigator

Clinical Trials Network & Institute, Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

Score ≥ 4 (at least moderate) on the CGI-S

Tobacco non-users as indicated by lack of tobacco use within the last 6 months prior to Screening, and by negative urinary cotinine level of < 50 ng/mL after quantification

Diagnosis of Inattentive predominant ADHD per DSM-IV TR) criteria at Screening

Treatment Details

Interventions

• Placebo (Other)
• TC-5619-238 25mg (Other)
• TC-5619-238 5mg (Other)

Participant Groups

Group I: TC-5619-238 (5 mg) Experimental Treatment 1 Intervention

TC-5619-238 5 mg will be provided as hard gelatin capsules.

Group II: TC-5619-238 (25mg) Experimental Treatment 1 Intervention

TC-5619-238 25 mg will be provided as hard gelatin capsules

Group III: Placebo Placebo Group 1 Intervention

Placebo will be provided as hard gelatin capsules similar to TC-5619-238

Who Is Running the Clinical Trial?

Targacept Inc.

Lead Sponsor

Trials

22

Recruited

9,800+