• 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 » Psyadon announces positive results from ecopipam Tourette’s study

Psyadon announces positive results from ecopipam Tourette’s study

January 19, 2017
CenterWatch Staff

Psyadon Pharmaceuticals, a company focused on treatments for neurological and psychiatric disorders, has announced that its lead product—ecopipam—produced significant reductions in total tic severity scores in children (7-17 years) with Tourette’s Syndrome.

The study’s primary endpoint was a statistically significant reduction in the mean Yale Global Tic Severity Score Total Tic Score (YGTSS-TTS). This is a well-validated and standard measure of the clinical efficacy of drugs treating Tourette’s Syndrome. Ecopipam caused significant reductions in the YGTSS-TTS at both two- and four weeks after initiating treatment. Furthermore, the side effects seen in the subjects taking ecopipam were comparable to those seen in the placebo-treated subjects, including no clinically significant changes in standard clinical lab tests or ECG’s, and no increases in body weights.

“Ecopipam works by blocking the dopamine D1 receptor which differentiates it from any other drug either on the market or currently in development. Since there hasn’t been a mechanistically new drug for the treatment of Tourette’s in over 30 years, this could offer a better option for people who suffer with the disease,” said Richard Chipkin, Ph.D., president and chief executive officer of Psyadon.

Donald Gilbert, M.D., the study’s Principal Investigator and professor and director of the Movement Disorder and Tourette Syndrome clinics at Cincinnati Children's Hospital Medical Center said, “Too many individuals with Tourette’s Syndrome remain symptomatic despite treatment with available drugs, or experience side effects like weight gain or sedation that limit their use. These results demonstrate the efficacy of D1 antagonism, an entirely new approach that doctors and scientists have speculated about for years. As importantly, the subjects in the study tolerated ecopipam very well, with no weight gain, sedation, or heart problems.”

The phase IIb study called “Ecopipam Treatment of Tourette’s Syndrome in Subjects 7-17 Years (PSY302),” was a double-blind, randomized, placebo-controlled crossover study conducted to assess the efficacy and safety of ecopipam in children with Tourette’s Syndrome.

Patients were instructed to take the study medication (either ecopipam or placebo) each evening before bedtime over a four-week treatment period. Patients were evaluated in the clinic every other week with telephone contacts on the alternate weeks. The primary efficacy endpoint was the change in the Yale Global Tic Severity Score-Total Tic Score (YGTSS-TTS), a well-validated rating scale typically used in Tourette’s Syndrome trials. The study was fully enrolled at 40 subjects.

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