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

NCT01472991 | Completed Phase 2

• 1 other identifier: TC-5619-238-CRD-004
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 14

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Conner's Adult ADHD-Investigator Version total score

  4 weeks

• Conner's Adult ADHD Rating Scale-Subject Self-Rating Version (CAARS-S)

  4 weeks

Study Arms (3)

TC-5619-238 (25mg)

EXPERIMENTAL

TC-5619-238 25 mg will be provided as hard gelatin capsules

Drug: TC-5619-238 25mg

Placebo

PLACEBO COMPARATOR

Placebo will be provided as hard gelatin capsules similar to TC-5619-238

Drug: Placebo

TC-5619-238 (5 mg)

EXPERIMENTAL

TC-5619-238 5 mg will be provided as hard gelatin capsules.

Drug: TC-5619-238 5mg

Interventions

TC-5619-238 5mg DRUG

TC-5619-238 5mg capsule taken once daily for 4 weeks

TC-5619-238 (5 mg)

TC-5619-238 25mg DRUG

TC-5619-238 25mg capsules taken once daily for 4 weeks

TC-5619-238 (25mg)

Placebo DRUG

Placebo capsules will be taken once daily for 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Targacept Inc.: lead

Study Sites (14)

Southwestern Research, Inc

Beverly Hills, California, 90210, United States

Location

Synergy Clinical Research Center

National City, California, 91920, United States

Location

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34201, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32216, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

Compass Research, Inc.

Orlando, Florida, 32806, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Clinical Trials Network & Institute, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Neuro-Behavioral Clinical Reseach, Inc.

Canton, Ohio, 44718, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

FutureSearch Clinical Trials, LP

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Timothy Wilens, MD

  Clinical Trials Network & Institute, Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 17, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

US (14)