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

Phase 2

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: TC-5619-238 25mg; Drug: Placebo; Drug: TC-5619-238 5mg

• Registration Number: NCT01472991
• Lead Sponsor: Targacept Inc.

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-04
• Disposition First Submitted: 2013-04-22
• Disposition First Submitted QC: 2013-04-22
• Last Update Submitted: 2013-04-22
• Disposition First Posted: 2013-04-30
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TC-5619-238 (25mg)	TC-5619-238 25mg	TC-5619-238 25 mg will be provided as hard gelatin capsules
Placebo	Placebo	Placebo will be provided as hard gelatin capsules similar to TC-5619-238
TC-5619-238 (5 mg)	TC-5619-238 5mg	TC-5619-238 5 mg will be provided as hard gelatin capsules.

Primary Outcome Measures

Name	Time	Method
Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV)	4 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Conner's Adult ADHD-Investigator Version total score	4 weeks	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).
Conner's Adult ADHD Rating Scale-Subject Self-Rating Version (CAARS-S)	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).

Trial Locations

Locations (12)

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Orlando, Florida, United States

Compass Research, Inc.; 🇺🇸 Orlando, Florida, United States

Florida Clinical Research Center, LLC; 🇺🇸 Maitland, Florida, United States

CNS Healthcare; 🇺🇸 Memphis, Tennessee, United States

Compass Research, LLC; 🇺🇸 Orlando, Florida, United States

Synergy Clinical Research Center; 🇺🇸 National City, California, United States

Southwestern Research, Inc; 🇺🇸 Beverly Hills, California, United States

Clinical Trials Network & Institute, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Neuro-Behavioral Clinical Reseach, Inc.; 🇺🇸 Canton, Ohio, United States

FutureSearch Clinical Trials, LP; 🇺🇸 Austin, Texas, United States

MCB Clinical Research Centers, LLC; 🇺🇸 Colorado Springs, Colorado, United States

Midwest Clinical Research Center; 🇺🇸 Dayton, Ohio, United States