- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01124708
Efficacy, Safety, and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)
A Double-blind, Randomized, Placebo-controlled, Multicenter, Fixed Dose Titration Study to Assess Efficacy, Safety, and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)
Study Overview
Detailed Description
A randomized, parallel, forced-titration design is being used to assess effects of TC-5619 versus placebo on efficacy. A parallel group design allows the effects of TC-5619 to be clearly established, and the randomized nature of the design allows minimization of observer and subject bias. Because a forced dose up-titration design will be used, effects of individual doses will be preliminary, because the design confounds dose with time.
The doses chosen (1mg, 5mg, and 25mg) reflect an appropriate range around the anticipated efficacious dose (3-10 mg), based upon preclinical extrapolations to the human, and upon the pro-cognitive effects of TC-5619 identified by CDR in the MRD study (Targacept Study TC-5619-238-CLP-002).
All subjects will be tobacco non-users. It is possible that tobacco (nicotine) interferes with α7 NNR-mediated effects.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Bradenton, Florida, United States, 34208
- Florida Clinical Research Center, LLC
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Jacksonville, Florida, United States, 32216
- Clinical Neuroscience Solutions, Inc.
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Lauderhill, Florida, United States, 33319
- Fidelity Clinical Research, Inc
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Maitland, Florida, United States, 32751
- Florida Clinical Research Center, LLC
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North Miami, Florida, United States, 33161
- Scientifc Clinical Research, Inc.
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Orlando, Florida, United States, 32806
- Clinical Neuroscience Solutions, Inc.
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Georgia
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Atlanta, Georgia, United States, 30308
- Atlanta Center For Clinical Research
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New Jersey
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Willingboro, New Jersey, United States, 08046
- CRI Worldwide, LLC (Lourdes Division)
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Ohio
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Canton, Ohio, United States, 44718
- Neuro-Behavioral Clinical Research, Inc.
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Dayton, Ohio, United States, 45417
- Midwest Clinical Research Center
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Oregon
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Portland, Oregon, United States, 97210
- Oregon Center For Clinical Investigations, Inc. (OBBI, Inc.)
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19139
- CRI Worldwide, LLC (Kirkbride Division)
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Tennessee
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Memphis, Tennessee, United States, 38119
- Clinical Neuroscience Solutions, Inc.
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Texas
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Austin, Texas, United States, 78756
- FutureSearch Clinical Trials, LP
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Houston, Texas, United States, 77008
- Claghorn-Lessem Research Clinic
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Vermont
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Burlington, Vermont, United States, 05401
- Fletch Allen Health Care, Dept. of Psychiatry, Univ. of Vermont
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of ADHD per DSM-IV TR criteria
- Score > 2 on at least 6 of 9 items in at least 1 subscale of the CAARS-INV
- Score > 4 (at least moderate) on the Clinical Global Impression-Severity (CGI-S) index
- Age 18 - 65, male or female
- Tobacco non-users as indicated by lack of tobacco use within the last year prior to Screening, and by negative urinary cotinine level of < 50ng/mL after quantification
- Able to understand and sign informed consent
Exclusion Criteria:
- Current DSM-IV Axis I psychiatric disorder other than ADHD; use of MINI to exclude other major DSM-IV TR psychiatric diagnoses
- Known or suspected drug abuse within the last 12 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
- Use of drugs affecting cognitive function within 3 weeks prior to Day 1, including use of any medications for treatment of ADHD. Any medication wash-outs must be completed during the 3 weeks between Screening and Day 1.
- Any other restricted or prohibited drugs.
- Other concomitant medications that have been changed within 4 weeks prior to Screening
- Unable to comply with study procedures in opinion of investigator, including CogState ADHD test battery
- History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, CV, 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 TB or known systemic infection (HBV, HCV, HIV)
- Clinically significant finding on physical exam
- Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF > 450 (males) or QTcF > 480msec (females), and excluding LFTs > 1.5 times upper limits of normal
- Women of child-bearing potential and men unwilling or unable to use accepted methods of birth control
- Women with a positive pregnancy test, or who are lactating
- Participation in another clinical trial in last 3 months prior to Screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo will be provided as white, opaque gelatin capsules in sham strengths of 1mg, 5mg, and 25mg
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Placebo will be provided as white, opaque gelatin capsules in sham strengths of 1mg, 5mg, and 25mg
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Active Comparator: TC-5619
TC-5619-238 will be provided as white, opaque gelatin capsules in strengths of 1mg, 5mg, and 25mg (as free base).
Subjects will take 1mg TC-5619, 5mg TC-5619, 25mg TC-5619, one capsule once daily p.o.
|
TC-5619-238 will be provided as white, opaque gelatin capsules in strengths of 1mg, 5mg, and 25mg (as free base).
Subjects will take 1mg TC-5619, 5mg TC-5619, 25mg TC-5619, or matching placebo - one capsule once daily p.o.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAARS-INV ADHD-rating scale
Time Frame: Week 12
|
•Clinician-administered ADHD-rating scale (CAARS-INV) and is the total of 3 subscales: Inattention, Hyperactivity-Impulsivity, and ADHD Index [ Time Frame: Week -3, Day 1, Week 1, Week 4 (evaluation of 1mg dose); Week 8 (evaluation of 5mg Dose); and Week 12 (evaluation of 25mg dose)]
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAARS-INV subscales
Time Frame: Week 12
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CAARS-INV subscales: Inattention, Hyperactivity-Impulsivity, and ADHD Index, obtained [Time frame: Week -3, Day 1, Week 1, Week 4, Week 8, Week 12,Early Withdrawal (EW)]
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Week 12
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CogState ADHD Battery
Time Frame: Week 12
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CogState ADHD test battery [Time frame: Week -3, Day 1, Week 1, Week 4, Week 8, Week 12,Early Withdrawal (EW)]
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Week 12
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CogState Stop-Signal Task scores
Time Frame: Week 12
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CogState Stop-Signal Task scores [Time frame: Week -3, Day 1, Week 1, Week 4, Week 8, Week 12,Early Withdrawal (EW)]
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Week 12
|
CAARS-Self Rating (CAARS-S) total score
Time Frame: Week 12
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CAARS-S total score [Time frame: Week -3, Day 1, Week 1, Week 4, Week 8, Week 12,Early Withdrawal (EW)]
|
Week 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul Newhouse, MD, Fletcher Allen Health Care, Dept. of Psychiatry
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TC-5619-238-CRD-002
- PRO-05619-CRD-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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