Participating in Clinical Trials
Every day, research uncovers new information about epilepsy and seizures. Your involvement in clinical trials could help in the development of new medications or medical devices. You and many others may benefit from your willingness to become involved.
Volunteering to participate in a clinical trial is one of the best ways you can contribute to the understanding of epilepsy. Volunteers are vital to the clinical trial phase of the drug approval process. As a volunteer, you are the most critical link in a long chain of research and testing in the development of new medications.
The benefits of volunteering to participate in a clinic trial include:
- Participating in a research process that may lead to new therapies.
- Obtaining expert medical care with physicians that specialize in epilepsy and seizures during the trial.
- Learning new information about your condition.
- Gaining access to new research treatments before they become available to the public.
How Does Minnesota Epilepsy Group Protect Patients?
When conducting clinical trials, Minnesota Epilepsy Group’s most important responsibility is to protect patients through well-designed protocols, oversight and approval by a a dedicated Institutional Review Board (IRB) and a thorough informed consent process.
Clinical Trial Protocol
A protocol is a detailed plan that explains what will be done in a clinical trial and why. The plan is carefully designed to protect your health and welfare while addressing specific research questions. It outlines how many patients will participate, what medical tests they will receive and how often, and the treatment and monitoring plan. Research staff follows the protocol approved by the Institutional Review Board (IRB).
Who Is the Institutional Review Board?
An Institutional Review Board (IRB) is a group of healthcare professionals and members of the local community that review and approve a clinical trial before it begins. The IRB carefully reviews clinical trial activity. The primary responsibility of the IRB is to protect the safety and rights of clinical trial participants.
What Is Informed Consent?
Informed consent is the process designed to give volunteers the information they need to decide about participating in a clinical trial. This process allows the volunteer to ask questions and to exchange information freely with the clinical investigator. The clinical investigator is responsible for ensuring the informed consent is obtained from each research volunteer before that person participates in the clinical trial. The consent is not a contract. You may decide not to participate at any time during the trial.
If you agree to participate in a clinical trial after learning all that is involved, then you, the trial’s principal investigator (or nurse, if called for in the protocol) and a witness will sign and date the informed consent form. A copy of the form will be given to you.
Currently Enrolling Research Studies at Minnesota Epilepsy Group
Please note that we are actively recruiting for the following studies even if Minnesota Epilepsy Group is not listed as such on the study’s ClinicalTrials.gov web page:
- Preventing Epilepsy Using Vigabatrin in Infants with Tuberous Sclerosis Complex (PREVeNT Trial): A randomized, double-blind, placebo-controlled seizure prevention clinical trial for infants with Tuberous Sclerosis Complex (TSC)
- < 6 months of age
- 0 AEDs
- 0 seizures
- Must have TSC
Adult and Pediatric Studies:
Diazepam Buccal Soluble Film: An open-label safety and tolerability study of chronic intermittent use of Diazepam Buccal Soluble Film in children and adults
- 2 – 65 years of age
- Currently on ≥ 1 AEDs
- Requires a rescue medication at least one time per month, on average
- Must have motor seizures with clear alteration of awareness
Human Epilepsy Project 2: An observational study to identify clinical characteristics and biomarkers that predict disease outcome, progression, and treatment response in participants with treatment-resistant focal epilepsy
- 16 – 65 years of age
- Currently on ≥ 1 AEDs and has failed ≥ 4 AEDs
- Must be having ≥ 4 focal seizures per month (≥2 must be observable)
- IQ higher than 70
- No NEEs in past 12 months
TAK-935-18-002 – A Multicenter, Open-Label, Pilot Study of TAK-935 (OV935) in patients with 15Q Duplication Syndrome or CDKL5 Deficiency Disorder (ARCADE STUDY)
- 2 – 35 years of age
- Currently on 1-6 AEDs
- Must be having on average 3 or more motor seizures per month for past 3 months
- Must have genetic report confirming diagnosis
If you are interested in learning more about participating in an epilepsy research study at Minnesota Epilepsy Group, please email Sarah Ellis at firstname.lastname@example.org or call our office at (651) 241-5290 and ask for Sarah Ellis.