• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Targacept initiates phase IIb study of TC-5214

Targacept initiates phase IIb study of TC-5214

May 30, 2013
CenterWatch Staff

Targacept, a clinical-stage biopharmaceutical company developing novel neuronal nicotinic receptors (NNR) therapeutics, plans the initiation of a phase IIb clinical study of TC-5214 as a treatment for overactive bladder (OAB). TC-5214 acts potently on alpha3beta4 and other NNRs located in or around the bladder  believed to play a key role in bladder contraction and signaling of the urge to urinate.

"Overactive bladder has a devastating effect on quality of life for millions of individuals, and currently available medications have significant drawbacks," said Eric Rovner, M.D., professor of urology, Medical University of S.C., College of Medicine, and an investigator in Targacept's study.

The phase IIb study is a double-blind, placebo-controlled, randomized, parallel-group trial to be conducted at sites in the U.S. The study's co-primary endpoints are change in micturition frequency per 24 hours and change in urinary incontinence episodes per 24 hours, in each case from baseline to 12 weeks. The study,  designed to enroll approximately 750 patients, includes a three-to-five-week screening period followed by a 12-week treatment period during which patients receive either one of three doses of TC-5214 (0.5mg, 1mg or 2mg) or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose).

Because orally administered TC-5214 is eliminated more than 90% unchanged through the bladder, Targacept believes the compound offers potential for a low dose to be beneficial while minimizing systemic side effects characteristic of current therapies and enhancing patient compliance.

TC-5214 was associated with exaggerated bladder effects in preclinical studies, including increased urinary retention and beneficial changes in bladder contraction, bladder capacity and frequency of urination. TC-5214 already has a substantial safety database resulting from prior clinical studies in approximately 2,400 subjects in a different indication.

"With a strong scientific rationale, supportive findings, measurable clinical endpoints and a well-defined regulatory path, we view overactive bladder as a promising indication for development of this advanced compound," said Dr. Stephen A. Hill, Targacept's president and CEO.

Upcoming Events

  • 17May

    Three Data Trends to Consider Now When Developing Your Decentralized Clinical Trial Strategy

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing