Clinical trial NCT01472991: Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Fixed Dose Study to Assess Efficacy, Safety, and Tolerability of TC-5619 in Adults With Inattentive-Predominant Attention Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Targacept Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 disorder (ADHD) utilizing the Connor's Adult ADHD Rating Scale-Investigator Completed Version (CAARS-INV) inattentive subscale scores through 4 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Inattentive predominant ADHD per DSM-IV TR) criteria at Screening
2. Score ≥ 2 on at least 6 of 9 items in the inattentive subscale of the CAARS-INV at Baseline (Day 1)
3. Score of \< 2 on at least 4 of 9 items in the hyperactive/impulsivity subscale of the CAARS-INV at Baseline (Day 1)
4. Score ≥ 4 (at least moderate) on the CGI-S
5. 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 Criteria:

1. Current DSM-IV Axis I psychiatric disorder other than ADHD;
2. Use of tobacco cessation agents within 4 weeks prior to Screening
3. Known or suspected drug abuse within the last 6 months prior to Screening
4. Urine drug screen positive for illegal or non-prescribed drugs at Screening
5. Patients at imminent risk of suicide or of danger to themselves or others as judged by the investigator
6. Use of drugs affecting cognitive function within 4 weeks prior to Day 1. This includes use of any concomitant medications for treatment of ADHD.
7. 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
8. Myocardial infarction within past year
9. Seizure disorder within past year
10. Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed)
11. HbA1C \> 7.4 at Screening
12. BMI \< 15 or \> 35; male weight \< 100 lbs; female weight \< 80 lbs.
13. Current tuberculosis (TB) or known systemic infection \[Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)\]
14. Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control
15. 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

Primary outcomes:
measure: Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV)
timeFrame: 4 weeks
Secondary outcomes:
measure: Conner's Adult ADHD-Investigator Version total score
timeFrame: 4 weeks
measure: Conner's Adult ADHD Rating Scale-Subject Self-Rating Version (CAARS-S)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Southwestern Research, Inc
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Boston
country: United States
facility: Clinical Trials Network & Institute, Massachusetts General Hospital
state: Massachusetts
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Reseach, Inc.
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials, LP
state: Texas
Study officials:
affiliation: Clinical Trials Network & Institute, Massachusetts General Hospital
name: Timothy Wilens, MD
role: PRINCIPAL_INVESTIGATOR
References: