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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Targacept Inc.
ClinicalTrials.gov Identifier:
NCT01472991
First received: November 14, 2011
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: TC-5619-238 5mg
Drug: TC-5619-238 25mg
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Targacept Inc.:

Primary Outcome Measures:
  • Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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:
  • Conner's Adult ADHD-Investigator Version total score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 250
Study Start Date: November 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TC-5619-238 (25mg)
TC-5619-238 25 mg will be provided as hard gelatin capsules
Drug: TC-5619-238 25mg
TC-5619-238 25mg capsules taken once daily for 4 weeks
Placebo Comparator: Placebo
Placebo will be provided as hard gelatin capsules similar to TC-5619-238
Drug: Placebo
Placebo capsules will be taken once daily for 4 weeks
Experimental: TC-5619-238 (5 mg)
TC-5619-238 5 mg will be provided as hard gelatin capsules.
Drug: TC-5619-238 5mg
TC-5619-238 5mg capsule taken once daily for 4 weeks

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472991

Locations
United States, California
Southwestern Research, Inc
Beverly Hills, California, United States, 90210
Synergy Clinical Research Center
National City, California, United States, 91920
United States, Colorado
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States, 80910
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34201
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32216
Florida Clinical Research Center, LLC
Maitland, Florida, United States, 32751
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32806
Compass Research, Inc.
Orlando, Florida, United States, 32806
Compass Research, LLC
Orlando, Florida, United States, 32806
United States, Massachusetts
Clinical Trials Network & Institute, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Ohio
Neuro-Behavioral Clinical Reseach, Inc.
Canton, Ohio, United States, 44718
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
United States, Tennessee
CNS Healthcare
Memphis, Tennessee, United States, 38119
United States, Texas
FutureSearch Clinical Trials, LP
Austin, Texas, United States, 78731
Sponsors and Collaborators
Targacept Inc.
Investigators
Principal Investigator: Timothy Wilens, MD Clinical Trials Network & Institute, Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Targacept Inc.
ClinicalTrials.gov Identifier: NCT01472991     History of Changes
Other Study ID Numbers: TC-5619-238-CRD-004
Study First Received: November 14, 2011
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Targacept Inc.:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014