Clinical Trials and other Research Studies
For Families and Physicians
Our program aims to offer new treatment options to children with challenging epilepsies. Many of these treatment options are tailored to rare forms of epilepsy. All of the below mentioned trials are conducted in cooperation with pharmaceutical companies. We are happy to discuss the pros and cons of these trials with you. These trials are open for patients not only in Alberta but also from neighbouring provinces. Reach out to us to learn more about travel support and how a clinical trial usually works.
Please contact our Ucalgary email address for all inquiries regarding clinical trials: pediatricepilepsypro@ucalgary.ca
For Pharmaceutical Companies
Dr Julia Jacobs-LeVan is the Principal Investigator for treatment trails at the Alberta Children’s Epilepsy Program.
Our program has the infrastructure to conduct pharmaceutically sponsored and investigator initiated clinical trails in children with refractory epilepsies. We have experience with conducting trials in rare conditions and can accept out of province referrals for these trials.
We are supported by the University of Calgary, which allows us to guarantee a quick study start-up and ensure that all activities are in alignment with the legal and ethical requirements.
Trials will be supported by two study-coordinators.
Please contact Clinical Trial Services for more information.
Ongoing Clinical Trials
Children with Dravet Syndrome
We are conducting the Takeda 3001 study for children aged 2-21 years with Dravet syndrome.
This is a global study to evaluate the efficacy, safety, and tolerability of Soticlestat as an adjunctive therapy in pediatric and young adult subjects with Dravet syndrome.
For more information about this study, please refer to Study Record | ClinicalTrials.gov
Study Coordinators:
Ransi Nayakarathna
Email: Ransi.Nayakarathna@albertahealthservices.ca
Netanya Asna Ashari
Email: Netanya.AsnaAshari@albertahealthservices.ca
We are participating in the Momentum 2 Study for children with Dravet Syndrome.
This study is available only for patients who participated in the Momentum 1 Study. Recruitment in our site is closed now for both Momentum 1 and 2 Studies.
For more information about the Momentum 1 study, you can find the ClinicalTrials.gov page here.
Study Coordinator:
Paola Meza Santoscoy
Children with Rett Syndrome
The ANAVEX2-73 study does not aim to prevent seizures, but improve development in children diagnosed with typical Rett Syndrome. The study is explained in detail here. You can find the ClilnicalTrials.go page here.
Study Coordinators:
Netanya Asna Ashari
Email: Netanya.AsnaAshari@albertahealthservices.ca
Ransi Nayakarathna
Children with CDKL5 deficiency disorder
We are participating in the CANDID study for children with CDKL5 Deficiency Disorder.
This is a natural history study that will prospectively follow individuals (newborn to 55 years of age) with confirmed CDKL5 deficiency disorder over the course of 3 years.
For more information about the CANDID study, please refer to Study Record | ClinicalTrials.gov
Study Coordinators:
Netanya Asna Ashari
Email: Netanya.AsnaAshari@albertahealthservices.ca
Ransi Nayakarathna
Email: Ransi.Nayakarathna@albertahealthservices.ca
Children with Lennox-Gastaut Syndrome
This is a global study to evaluate the efficacy, safety, and tolerability of Soticlestat as an adjunctive therapy in pediatric and adult subjects with Lennox-Gastaut Syndrome between 2-55 years of age.
For more information about this study, please refer to Study Record | ClinicalTrials.gov
Study Coordinators:
Ransi Nayakarathna
Email: Ransi.nayakarathna@albertahealthservices.ca
Netanya Asna Ashari
Email: Netanya.AsnaAshari@albertahealthservices.ca
Other Research Studies
K2E Research Study
The purpose of this research study is to analyze the influence that the exposure to a structured and guided virtual educational platform about epilepsy (Knowledge2Empower) can have on the anxiety burden and quality of life of children and their parents after the first, unprovoked seizure; or after being diagnosed with epilepsy.
Epileptic seizures are the most common neurological symptom in childhood. A diagnosis of seizures and epilepsy usually results in a lot of stress and anxiety for the families. To date, the Neurology Clinic at the Alberta Children’s Hospital does not offer a program to support the families experiencing a seizure for the first time, or families who have just received the diagnosis of epilepsy for one of their family members beyond the therapeutical approach offered by the physicians.
Having a support program in place is very important because the connection between anxiety and epilepsy as a chronic disease has been relatively well researched. Patients with epilepsy show a higher level of anxiety and a higher rate of anxiety disorders. Even if the first, unprovoked epileptic seizure is initially a one-off event, it has been shown that the impact of a first epileptic seizure on health-related quality of life is comparable to that of newly diagnosed epilepsy.
A recent study done by our collaborators in Germany demonstrated that early intervention through a ‘First Seizure Clinic’ was able to reduce the anxiety in families experiencing a seizure for the first time. We believe that educating the families about what is happening to their affected relative and what to expect, will help decrease the levels of anxiety caused by the shock of experiencing a first seizure or receiving the diagnosis of epilepsy. This is the reason why we created Knowledge2Empower.
Knowledge2Empower is easily accessible through the internet, and it allows us to tailor the content according to the educational needs of the families. In comparison to support groups where attendance must be in person, Knowledge2Empower enables the families to decide when they want to watch the content and they can determine the pace they want to go through it. Making it easier for busy families to participate in this program without the pressure of having to take time off work or look for alternative childcare to attend an in-person session.
Study Design
If you want to participate in this study, you will be randomized into one of two groups: Early Access to Videos or Late Access to Videos as shown above. Your participation in the study will last 12 months from the moment you sign the consent form.