Clinical Trial

Clinical trials are crucial to learning and are required for commercial licensing of therapeutic drugs.  Field trials that are required by FDA to licence treatments are called effectiveness studies.

  • Effectiveness studies are placebo or "active" controlled studies using natural disease cases.
  • Effectiveness studies that were used to license drugs are available to the public. Search using the key words "Freedom of Information Summary (fill in the drug name here).
  • A client consent form is required for this type of study.

Some of our trials are designed to gather data from animals suffering from EPM or EPM related diseases, they are potential clinical benefit studies.

  • Potential benefit studies aren't always controlled studies.
  • Potential benefit studies are used to support the FDA submissions.
  • A veterinarian is involved in this type of study.

Please read the entrance requirements for each study. Studies vary, some are placebo controlled or are designed to use an active control (the "placebo" is a licensed EPM medication).  Some studies are designed to show potential benefits of the treatment and are uncontrolled. A PLACEBO CONTROLLED STUDY WILL BE CLEARLY EXPLAINED BEFORE YOU ENROLL.  YOU MAY NOT ENTER A PLACEBO CONTROLLED STUDY WITHOUT SIGNING AND RETURNING THE INFORMATION FORM.

RESCUE PROGRAM

In the last two years Pathogenes has donated over $20,000 in services and medications to diagnose and treat horses in need.  In 2017 we require a copy of the tax exempt status of the organization (rescue) associated with the horse. To participate in our rescue program please submit:

  • A serum sample,
  • A synopsis of the horses history and prior treatment,
  • Brief description of the need,
  • A copy of the 501 (c) 3 status of the organization.

Horses that don't require a 501 (c) 3:

  • Miniature horses are exempt from the 501 (c) 3 status requirement,
  • Zoo animals are exempt from the 501 (c) 3 status requirement,
  • Horses with penile paralysis, urinary incontinence, bowel stasis may be exempt from the 501 (c) 3 status.

 

OROGIN FIELD EFFECTIVENESS STUDY

The protocol is designed to determine the difference between treatment success rate between Orogin and a licensed agent, Protazil, in a non-inferiority study.

  • All adult horses of any breed of either sex may enroll;
  • Clinical signs characterized by a gait assessment score of > 2 and < 5;
  • A diagnosis of EPM supported by IFAT testing, positive serum: CSF ratio <100;
  • A diagnosis of EPM supported by additional diagnostic work up to rule out other causes of ataxia;
  • Has not been treated for EPM within 60 days of enrollment.

Exclusion criteria are the same as those that are found in the Freedom of Information Summary for Protazil. FIS Protazil.  Veterinarians are invited to inquire and receive the protocol for this study.

 

NEUROQUEL FIELD EFFECTIVENESS STUDY

This study has FDA concurrence.  The study objectives are intended to evaluate the effectiveness of NeuroQuel over a placebo for the treatment of residual or recurrent clinical signs of EPM. The entrance requirements are:

  • A horse between 2-20 years weighing at least 600 pounds of either sex;
  • Must have an original diagnosis of EPM that includes:
    • A positive test for EPM (CSF testing required);
  • Treated for EPM using an FDA approved treatment within 90 days of enrollment;
  • Residual signs of EPM that include a gait assessment score (GAS) of 2 by the end of treatment or that recurred after the cessation of therapy.

A signed consent form must be completed for this study. NQ Owner Consent.  Veterinarians are invited to call and receive the protocol for this study.

EPM PREVENTION STUDY (potential benefit study)

The study objectives are to elucidate conditions present in "sidewinder" horses, evaluate dose and duration of therapy, and monitor relapses.

  • Any age, breed, or sex may be considered for entry into the study;
  • A horse must show chronic, relapsing/remitting signs of "EPM" after treatment for EPM;
  • Relapses may be between 90 days to five years;
  • The horse must have no signs of EPM to enter the study;
  • A veterinarian must be involved in the case.

Preliminary results have been obtained from 117 horses.  The initial data is under review for publication.