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CANINE EPILEPSY CLINICAL TRIAL

METriC: MiRNA-134 -antisense-oligonucleotide Epilepsy Treatment in Canines

A randomised double blinded placebo-controlled study: Helping dogs and humans with epilepsy

Canine epilepsy

Canine epilepsy is the most common neurological disorder in dogs. Up to one third of epileptic dogs do not respond to conventional anti-seizure medications affecting their quality of life and causing owners significant levels of anxiety.

Human epilepsy

Temporal lobe epilepsy is an acquired form of epilepsy resulting from a complex mixture of cellular and molecular modifications. It is the most common type of epilepsy in adults and as it is the case in dogs, up to one third of epileptic patients do not respond to conventional anti-seizure medications. Hence there is a need to look for new medications that act in a different way.

What is a clinical research study?

Clinical studies evaluate medical treatments to make sure they are safe and effective before they are approved and released to the general population. Studies are carefully designed and monitored with dog’s safety as the priority.

About this study

This study will test how safe and effective a new study medication is in dogs with canine idiopathic epilepsy non-responsive to conventional anti-seizure medications. This medication has never been used in dogs or humans before.

The study medication

The study medication (called Ant-134) silences a molecule called miRNA-134. MiRNAs are small non-coding RNAs that regulate protein levels within cells. The brain expresses several unique miRNAs, which are critical in development and function, including regulating neuronal structures including dendritic spines and hence influencing synaptic transmission. Initial results in other species showed long-lasting seizure control with no side effects. It is given as a single injection into the cerebrospinal fluid under general anaesthesia.

Further information regarding previous studies of the medication:

Is my dog eligible for this study

Your epileptic dog will have to fulfill the following criteria to enter the study:

Age: more than 2 years
Weight more than 5kg
Diagnosis of idiopathic epilepsy with a normal MRI scan and CSF
Having more than 4 seizures a month despite having tried at least 2 anti-seizure medications
Deemed otherwise healthy

Randomization

Dogs will be randomly placed (like the toss of a coin) into one of the study treatment groups. One group will receive the study medication and the other will receive a placebo. The placebo looks just like the study medication but contains no active ingredient. The dog owner, and study veterinarian will not know who is receiving the study medication and who is receiving a placebo. At the end of the study, the study medication will be offered to the dogs that received placebo, if there is evidence that it is safe and effective

Your responsibilities

Participation in the study is voluntary. Before your dog joins the study, you will read and sign an informed consent stating that you agree for your dog to be in the study. This is not a contract, and you are free to stop participating in the study for any reason at any time.

You will be required to attend the study site visits at the Small Animal Hospital of the University of Glasgow. You will also need to keep a record of your dog’s seizures and send us the information once a month.

Visits:

Day of treatment: your dog will stay in hospital for a minimum of 2 days
Day 15: Day visit
Day 45: Day visit
Day 90: Day visit
Day 180: Day visit

Cost

The study medication and all study-related procedures will be provided FREE of charge.

Benefits of participating

Clinical studies offer hope in an otherwise hopeless situation. This study offers the possibility of acquiring new knowledge, that has the potential to help many dogs, and maybe even humans with epilepsy in the future.