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

Completed · Phase 2 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT01472991

Run by

Targacept Inc.

People needed

250

Starts

2011-11-01

Expected to finish

2012-07-01

Last updated by the study team

2013-04-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of Inattentive predominant ADHD per DSM-IV TR) criteria at Screening
• Score ≥ 2 on at least 6 of 9 items in the inattentive subscale of the CAARS-INV at Baseline (Day 1)
• Score of < 2 on at least 4 of 9 items in the hyperactive/impulsivity subscale of the CAARS-INV at Baseline (Day 1)
• 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

You may not qualify if…

• Current DSM-IV Axis I psychiatric disorder other than ADHD;
• Use of tobacco cessation agents within 4 weeks prior to Screening
• Known or suspected drug abuse within the last 6 months prior to Screening
• Urine drug screen positive for illegal or non-prescribed drugs at Screening
• Patients at imminent risk of suicide or of danger to themselves or others as judged by the investigator
• Use of drugs affecting cognitive function within 4 weeks prior to Day 1. This includes use of any concomitant medications for treatment of ADHD.
• History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular (CV), gastrointestinal (GI), or urological disorder; or diagnosis of major depressive disorder
• Myocardial infarction within past year
• Seizure disorder within past year
• Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed)
• HbA1C > 7.4 at Screening
• BMI < 15 or > 35; male weight < 100 lbs; female weight < 80 lbs.
• Current tuberculosis (TB) or known systemic infection [Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)]
• Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control
• Participation in another Central Nervous System (CNS)-related clinical trial in the last 3 months and any other clinical trial in last 30 days prior to Screening, or participation in a previous TC-5619 clinical trial

Where it is running

• Southwestern Research, Inc — Beverly Hills, California, United States
• Synergy Clinical Research Center — National City, California, United States
• MCB Clinical Research Centers, LLC — Colorado Springs, Colorado, United States
• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Florida Clinical Research Center, LLC — Maitland, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Compass Research, Inc. — Orlando, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Clinical Trials Network & Institute, Massachusetts General Hospital — Boston, Massachusetts, United States
• Neuro-Behavioral Clinical Reseach, Inc. — Canton, Ohio, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• CNS Healthcare — Memphis, Tennessee, United States
• FutureSearch Clinical Trials, LP — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.