Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)
NCT ID: NCT01472991
Last Updated: 2013-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2011-11-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TC-5619-238 (25mg)
TC-5619-238 25 mg will be provided as hard gelatin capsules
TC-5619-238 25mg
TC-5619-238 25mg capsules taken once daily for 4 weeks
Placebo
Placebo will be provided as hard gelatin capsules similar to TC-5619-238
Placebo
Placebo capsules will be taken once daily for 4 weeks
TC-5619-238 (5 mg)
TC-5619-238 5 mg will be provided as hard gelatin capsules.
TC-5619-238 5mg
TC-5619-238 5mg capsule taken once daily for 4 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
Yes
Sponsors
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Targacept Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy Wilens, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Trials Network & Institute, Massachusetts General Hospital
Locations
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Southwestern Research, Inc
Beverly Hills, California, United States
Synergy Clinical Research Center
National City, California, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Compass Research, Inc.
Orlando, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Clinical Trials Network & Institute, Massachusetts General Hospital
Boston, Massachusetts, United States
Neuro-Behavioral Clinical Reseach, Inc.
Canton, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
CNS Healthcare
Memphis, Tennessee, United States
FutureSearch Clinical Trials, LP
Austin, Texas, United States
Countries
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Other Identifiers
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TC-5619-238-CRD-004
Identifier Type: -
Identifier Source: org_study_id