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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

November 14, 2011
April 22, 2013
November 2011
July 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01472991 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)
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 is to assess if TC-5619 improves symptoms for adults diagnosed with the inattentive-predominant subtype of ADHD over a 4-week treatment period.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: TC-5619-238 5mg
    TC-5619-238 5mg capsule taken once daily for 4 weeks
  • Drug: TC-5619-238 25mg
    TC-5619-238 25mg capsules taken once daily for 4 weeks
  • Drug: Placebo
    Placebo capsules will be taken once daily for 4 weeks
  • Experimental: TC-5619-238 (25mg)
    TC-5619-238 25 mg will be provided as hard gelatin capsules
    Intervention: Drug: TC-5619-238 25mg
  • Placebo Comparator: Placebo
    Placebo will be provided as hard gelatin capsules similar to TC-5619-238
    Intervention: Drug: Placebo
  • Experimental: TC-5619-238 (5 mg)
    TC-5619-238 5 mg will be provided as hard gelatin capsules.
    Intervention: Drug: TC-5619-238 5mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01472991
TC-5619-238-CRD-004
No
Targacept Inc.
Targacept Inc.
Not Provided
Principal Investigator: Timothy Wilens, MD Clinical Trials Network & Institute, Massachusetts General Hospital
Targacept Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP