Ongoing Clinical Trials

Open Label Randomized Clinical Trial of the Use of Huperzine A as compared to Phenobarbital Treatment of Canine Epilepsy

Our hospital is enrolling naturally occurring epileptic dogs  in a new study  to compare Huperzine A to Phenobarbital treatment in the control of seizures. The goal of this study is to determine if Huperzine A is comparable to Phenobarbital therapy in dogs with canine epilepsy in reducing the frequency of seizures.

Huperzine A is a natural plant derivative found to be safe in dogs and proven to reduce the level of brain excitation.   As such, this compound may have antiepileptic properties to help canine patients resistant to phenobarbital therapy.

This is an open label, non-placebo controlled clinical field study for dogs that are known epileptic dogs with suspected or confirmed idiopathic epilepsy based on one of the following criteria:

  • Age of onset of the first seizure between 1 to 7 years, with a normal neurologic exam and no metabolic disease at screening , or any exposure/ingestion of toxins that could account for seizures.
  • A history of 3 or more generalized seizures within the 6 months prior to enrollment, but no evidence of cluster seizures (3 seizures within 24 hours).
  • Normal screening physical
  • Prior treatment with an epileptic drug is allowed only if treatment duration was 3 days or less. If a dog was treated with an anti-seizure medication for 3 days or less, then there will be a 3 day wash period prior to starting study.
  • Age: ≥ 1 year
  • Weight: > 5kg
  • Non-pregnant, non-lactating, not intended for breeding

Benefits to your client:

Dogs that qualify will receive the following at no cost:

  • Physical and neurological examinations (pre and post-therapy)
  • CBC/Chemistry/UA (pre and post-therapy)
  • Phenobarbital blood levels (pre and post-therapy)
  • Huperzine A or Phenobarbital medication
  • $100 gift certificate upon enrollment and $100 gift certificate upon completion

Duration of study: The study duration is 6 months

Referring veterinarians will also receive a $100 gift certificate for each patient enrolled into the study.

Please contact us if you have any patients that you are feel are eligible to be enrolled in this study.

Dr. Michael Podell, Diplomate ACVIM (Neurology)
mpodell@cvesc.net

Jennifer Stalter, BS,  CVT
Clinical Trials Coordinator
jstalter@cvesc.net

 

OPEN LABEL CLINICAL TRIAL OF THE BENEFIT OF CONVECTION ENHANCED DELIVERY (ced) OF TEMOZOLOMIDE ENCAPSULATED NANOPARTICLES FOR THE TREATMENT OF CANINE GlIOMA

We are currently enrolling canine patients into a new clinical trial to treat glioma.  This is a collaborator study with the Department of Neurosurgery in the Pritzker School of Medicine at the University of Chicago to assess the feasibility and potential efficacy of a novel delivery method of chemotherapy directly to the affected region of the brain.

BACKGROUND INFORMATION

Major obstacles to the effective treatment of malignant brain tumors in people and dogs include the poor delivery of therapeutic agents across the blood brain barrier, the inability to specifically target cancerous cells, and the toxicity of systemically administered agents to normal tissues. In addition, the inability to image the distribution of therapeutic agent hampers the planning of subsequent treatments.

To address these issues, investigators at the University of Chicago have developed a treatment strategy involving direct brain delivery of biocompatible nanoparticles (NPs).  We plan on using poly lactic acid/ polycaprolacton / magnetite nanoparticles (PMNPs) encapsulating a chemotherapeutic agent, temozolomide,  that is introduced by convection enhanced delivery (CED) to allow real-time magnetic resonance imaging (MRI) during therapy.  The goal is to provide targeted chemotherapy to the area of the tumor that can be monitored at time of drug delivery to enhance tumor therapy while sparing normal brain tissue in dogs and people.

ELIGIBLE PATIENTS:

  • Any brachycephalic dog (Boxers, Boston terriers, bulldogs) with new onset of epileptic seizures over the age of 5 years without any metabolic diseases.
  • Any dog previously diagnosed with a highly suspected glioma based on MRI findings or biopsy confirmation.

STUDY REQUIREMENTS:

This will be an open-label, non-placebo controlled clinical field study using dogs with naturally occurring glioma. A target of 10 dogs will be enrolled in this study.

Eligible dogs will undergo an initial screening MRI scan with anesthesia, CED treatment and a follow-up MRI scan after treatment for enrolled dogs at NO COST TO THE OWNER.

Qualifying dogs in this study will receive a single dose of an investigational product, poly lactic acid/ polycaprolactone /magnetite nanoparticles (PMNPs) encapsulating a chemotherapeutic agent, temozolomide,  via CED.  The patient will be evaluated at 60 day intervals over a 6 month period.  Additional tumor therapy as needed is allowed at the owner’s cost.

CONTACT INFORMATION:

For further information of questions please contact:
Dr. Michael Podell at mpodell@cvesc.net or 773-281-7110