Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder

Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate with or without incontinence (leaking). The purpose of this study is to test whether dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of OAB.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Placebo; Drug: dexmecamylamine

Detailed Description

The study included a three- or five-week screening period, followed by a 12-week treatment period during which patients received either one of three doses of dexmecamylamine or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a two-week follow-up period. A total of 768 subjects with overactive bladder were randomized into the double-blind treatment period of the study.

• Study Type: Interventional
• Enrollment (Actual): 1635
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Simon-Williamson Clinic, P.C.
    • Dothan, Alabama, United States, 36305
      • Physician's Resource Group
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc
    • Mobile, Alabama, United States, 36608
      • Mobile Ob-Gyn, P.C.
    • Mobile, Alabama, United States, 33324
      • Coastal Clinical Research, Inc.
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Radiant Research, Inc.
    • Glendale, Arizona, United States, 85306
      • Clinical Trials of Arizona, Inc.
    • Phoenix, Arizona, United States, 85051
      • Beach Clinical Studies
    • Scottsdale, Arizona, United States, 85251
      • Radiant Research, Inc.
    • Tucson, Arizona, United States, 85710
      • Radiant Research, Inc.
    • Tucson, Arizona, United States, 85704
      • Genova Clinical Research, Inc.
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
  • California
    • Long Beach, California, United States, 90806
      • Atlantic Urology Medical Group
    • Los Angeles, California, United States, 90036
      • Adam D. Karnes, MD
    • Murrieta, California, United States, 92562
      • Tri Valley Urology Medical Group
    • Paramount, California, United States, 90723
      • Center for Clinical Trials, LLC
    • Sacramento, California, United States, 95821
      • Northern California Research
    • San Diego, California, United States, 92120
      • San Diego Sexual Medicine
    • San Diego, California, United States, 92123
      • Genesis Research
    • Thousand Oaks, California, United States, 91360
      • Westlake Medical Research
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center, LLC
    • Denver, Colorado, United States, 80211
      • InFocus Clinical Research
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • Women's Health Specialty Care
    • Middlebury, Connecticut, United States, 06762
      • Connecticut Clinical Research Center, LLC
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Brooksville, Florida, United States, 34601
      • Meridien Reseach
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • Coral Springs, Florida, United States, 33065
      • 3H Clinical Research Corporation
    • Hialeah, Florida, United States, 33012
      • Palm Spring Research Institute
    • Kissimmee, Florida, United States, 34741
      • American Medical Research Institute
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Lauderdale Lakes, Florida, United States, 33319
      • Sunrise Medical Research
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute, Inc.
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • Plant City, Florida, United States, 33563
      • Clinical Research of Central Florida
    • Summerfield, Florida, United States, 34491
      • Lakeview Medical Research
    • Tallahassee, Florida, United States, 32308
      • Southeastern Research Group, Inc.
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Central Florida
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Atlanta Medical Research Institute
    • Atlanta, Georgia, United States, 30342
      • Radiant Reseach, Inc.
    • Columbus, Georgia, United States, 31904
      • Southeast Regional Research Group
    • Roswell, Georgia, United States, 30076
      • Perimeter North Medical Research, Inc.
    • Savannah, Georgia, United States, 31406
      • Fellows Research Alliance, Inc.
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • North Idaho Urology
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Radiant Research, Inc.
    • Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists, Inc.
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology PSC
    • Newburgh, Indiana, United States, 47630
      • Deaconess Clinic Gateway Health Center
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Heartland Research Associates, LLC
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates, LLC
    • Shawnee, Kansas, United States, 66218
      • GTC Research
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40291
      • Bluegrass Clinical Research
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity, LLC
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
    • Shreveport, Louisiana, United States, 71115
      • Willis-Knighton Physician Network
  • Maryland
    • Greenbelt, Maryland, United States, 20770
      • Mid Atlantic Urology Associates, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials, Inc.
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research, LLC
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc.
  • Michigan
    • Grand Rapids, Michigan, United States, 49544
      • Family Medicine Specialists, PC
    • Kalamazoo, Michigan, United States, 49009
      • Beyer Research
    • Kalamazoo, Michigan, United States, 49009
      • Westside Family Medical Center, Pc
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Reseach Group, LLC
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Radiant Research, Inc.
    • Woodbury, Minnesota, United States, 55125
      • Metro Urology
  • Mississippi
    • Carriere, Mississippi, United States, 39426
      • Mississippi Medical Research, LLC
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center For Pharmaceutical Research
    • St. Louis, Missouri, United States, 63141
      • Radiant Research, Inc.
  • Montana
    • Billings, Montana, United States, 59102
      • Montana Health Research Institute, Inc.
    • Missoula, Montana, United States, 59808
      • Five Valleys Urology
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinical of Lincoln, P.C.
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Summit Medical Group
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence Ob-Gyn Clinical Research, LLC
    • Voorhees, New Jersey, United States, 08043
      • Delaware Valley Urology, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
    • Albuquerque, New Mexico, United States, 87109
      • Southwest Clinical Research
  • New York
    • Albany, New York, United States, 12208
      • The Urological Institute of Northeastern New York
    • Garden City, New York, United States, 11530
      • Advanced Urology Centers of New York
    • Kingston, New York, United States, 12401
      • Premier Medical Group of the Hudson Valley, PC
    • New York, New York, United States, 10016
      • Manhattan Medical Research Practice PLLC
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley, PC
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research, Inc.
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
    • Columbus, Ohio, United States, 43212
      • Radiant Research, Inc.
    • Zanesville, Ohio, United States, 43701
      • Physicians' Research, Inc.
  • Pennsylvania
    • Bala Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of SE PA
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia, LLC
    • West Reading, Pennsylvania, United States, 19611
      • Advanced Clinical Concepts
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • Greater Providence Clinical Research, LLC
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc.
    • Bluffton, South Carolina, United States, 29910
      • Fellows Research Alliance, Inc.
    • Charleston, South Carolina, United States, 29407
      • Medical Research South, LLC
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
    • Simpsonville, South Carolina, United States, 29681
      • Hillcrest Clinical Research, LLC
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Meridian Clinical Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic
    • Johnson City, Tennessee, United States, 37601
      • Advanced Therapeutics, Inc.
    • Nashville, Tennessee, United States, 37203
      • Tennesse Women's Care
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc.
    • Bryan, Texas, United States, 77802
      • DiscoverResearch, Inc.
    • Carrollton, Texas, United States, 75010
      • Research Across America
    • Dallas, Texas, United States, 75234
      • Research Across America
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78209
      • Quality Research Inc.
    • San Antonio, Texas, United States, 78229
      • Radiant Reseach, Inc.
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Associates of Tidewater, Inc.
    • Norfolk, Virginia, United States, 23502
      • The Group for Women
  • Washington
    • Mountlake Terrace, Washington, United States, 98043
      • Integrity Medical Research, LLC
    • Renton, Washington, United States, 98055
      • Valley Women's Clinic
    • Seattle, Washington, United States, 98105
      • Seattle Women's Health, Research, Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Verified medical history of overactive bladder for at least 6 months
• Capable of walking unassisted to use the bathroom
• Able to measure voided urine volume and complete the diary without assistance
• If the subject is currently being treated with an OAB medication, the subject is willing to discontinue OAB medications while participating in this study

Exclusion Criteria:

• Diagnosis of a neurological disease affecting bladder function
• Stress incontinence, insensate incontinence, overflow incontinence or incontinence due to urinary fistula
• History of incomplete bladder emptying, bladder outflow obstruction or post-void residual bladder volume > 150 mL
• Males with benign prostatic hyperplasia or with a prostate-specific antigen (PSA) of 4 ng/mL or more
• Other urinary tract pathology such as malignancy, ureteric reflux, bladder stone, uninvestigated hematuria, urethral stricture, or cystitis
• Prior treatment with intravesical or intraprostatic botulinum toxin in the last 2 years
• Myasthenia gravis
• Angle closure glaucoma
• Current implantation of interstim electrodes or vaginal surgical mesh
• Presence of a clinically significant medical condition at any time during the study
• Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs
• Participated in an investigational drug trial within 3 months of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; One tablet of placebo to be administered orally twice a day.	Drug: Placebo
EXPERIMENTAL: 0.5 mg dexmecamylamine (TC-5214); One tablet of 0.5 mg dexmecamylamine to be administered orally twice a day.	Drug: dexmecamylamine; Other Names: TC-5214
EXPERIMENTAL: 1 mg dexmecamylamine (TC-5214); One tablet of 1 mg dexmecamylamine to be administered orally twice a day.	Drug: dexmecamylamine; Other Names: TC-5214
EXPERIMENTAL: 2 mg dexmecamylamine (TC-5214); One tablet of 2 mg dexmecamylamine to be administered orally twice a day.	Drug: dexmecamylamine; Other Names: TC-5214

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in micturition frequency per 24 hours	Micturition: Any voiding episode recorded by the patient as "urinated" either with or without incontinence.	12 weeks
Change from baseline in urinary urge incontinence (UUI) episodes per 24 hours		12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the volume voided per micturition		12 weeks
Change from baseline in nocturia per 24 hours	Nocturia: A micturition that wakes the subject from sleep between the time the subject went to bed and the time the subject woke up.	12 weeks
Clinical Global Impression of Improvement (CGI-I)		12 weeks
Change from baseline in Patient Perception of Bladder Condition (PPBC)		12 weeks
Change from baseline in the Urgency Questionnaire		12 weeks
Change from baseline in disease specific quality of life (OABq)		12 weeks

Collaborators and Investigators

• Sponsor: Targacept Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (ESTIMATE): June 4, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: TC-5214-23-CRD-003