Efficacy, Safety, and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)

NCT01124708 | Completed Phase 2

• 2 other identifiers: TC-5619-238-CRD-002PRO-05619-CRD-002
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 16

Brief Summary

ADHD has been associated with persistent deficits in the efficient allocation of attention and supports the notion that regulation of the cholinergic system may improve these cognitive deficits in ADHD. It has been suggested that the effects of nicotine are most pronounced on tasks that demand effortful processing (Rusted and Warburton 1994). In addition, a recent theory proposes that the cholinergic system allocates additional attentional resources during tasks that are demanding (i.e. sustained attention, set shifting, etc; Sarter and Bruno 1997). Thus it may be that in ADHD, cholinergic systems are under-responsive or under-developed and thus stimulation of nicotinic receptors via nicotinic agents may result in improved cognitive performance particularly on tests requiring effortful processing.

Conditions

ADHD

Keywords

ADHD; Attention Deficit Hyperactive Disorder

Outcome Measures

Primary Outcomes (1)

• CAARS-INV ADHD-rating scale

  •Clinician-administered ADHD-rating scale (CAARS-INV) and is the total of 3 subscales: Inattention, Hyperactivity-Impulsivity, and ADHD Index \[ Time Frame: Week -3, Day 1, Week 1, Week 4 (evaluation of 1mg dose); Week 8 (evaluation of 5mg Dose); and Week 12 (evaluation of 25mg dose)\]

  Week 12

Secondary Outcomes (4)

• CAARS-INV subscales

  Week 12

• CogState ADHD Battery

  Week 12

• CogState Stop-Signal Task scores

  Week 12

• CAARS-Self Rating (CAARS-S) total score

  Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo will be provided as white, opaque gelatin capsules in sham strengths of 1mg, 5mg, and 25mg

Drug: Placebo

TC-5619

ACTIVE COMPARATOR

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.

Drug: TC-5619-238

Interventions

TC-5619-238 DRUG

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.

TC-5619

Placebo DRUG

Placebo will be provided as white, opaque gelatin capsules in sham strengths of 1mg, 5mg, and 25mg

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 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Targacept Inc.: lead

Study Sites (16)

Florida Clinical Research Center, LLC

Bradenton, Florida, 34208, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32216, United States

Location

Fidelity Clinical Research, Inc

Lauderhill, Florida, 33319, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Scientifc Clinical Research, Inc.

North Miami, Florida, 33161, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

Atlanta Center For Clinical Research

Atlanta, Georgia, 30308, United States

Location

CRI Worldwide, LLC (Lourdes Division)

Willingboro, New Jersey, 08046, United States

Location

Neuro-Behavioral Clinical Research, Inc.

Canton, Ohio, 44718, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Oregon Center For Clinical Investigations, Inc. (OBBI, Inc.)

Portland, Oregon, 97210, United States

Location

CRI Worldwide, LLC (Kirkbride Division)

Philadelphia, Pennsylvania, 19139, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

FutureSearch Clinical Trials, LP

Austin, Texas, 78756, United States

Location

Claghorn-Lessem Research Clinic

Houston, Texas, 77008, United States

Location

Fletch Allen Health Care, Dept. of Psychiatry, Univ. of Vermont

Burlington, Vermont, 05401, 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

• Paul Newhouse, MD

  Fletcher Allen Health Care, Dept. of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 17, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: September 13, 2013

Record last verified: 2011-10

Locations

US (16)