Status:
COMPLETED
Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Targacept Inc.
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 dis...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01472991
Start Date
November 1 2011
End Date
July 1 2012
Last Update
April 30 2013
Active Locations (14)
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1
Southwestern Research, Inc
Beverly Hills, California, United States, 90210
2
Synergy Clinical Research Center
National City, California, United States, 91920
3
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States, 80910
4
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34201