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

Attention Deficit Hyperactivity Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472991
• Other study ID #: TC-5619-238-CRD-004
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2011
• Last updated: April 22, 2013
• Start date: November 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2013
• Source: Targacept Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• TC-5619-238 5mg
TC-5619-238 5mg capsule taken once daily for 4 weeks
• TC-5619-238 25mg
TC-5619-238 25mg capsules taken once daily for 4 weeks
• Placebo
Placebo capsules will be taken once daily for 4 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Targacept Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV)	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).	4 weeks	No
Secondary	Conner's Adult ADHD-Investigator Version total score	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).	4 weeks	No
Secondary	Conner's Adult ADHD Rating Scale-Subject Self-Rating Version (CAARS-S)	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).	4 weeks	No