For Patients
The following information is intended for patients outside of the United States and is not intended for US audiences.
About the MRTLE2 Study
The MRTLE Study wants to learn more about the safety and effectiveness of an investigational medication for epilepsy that is not controlled with other anti-epileptic drugs.
Adults who enter the study will have a 50/50 chance of receiving the investigational medication or placebo, a substance that looks like the study drug, but has no active ingredients. The medication will be given through an implantable pump.
All participants will have the pump system implanted. After recovering from surgery, they will be randomly placed in one of two groups. One will receive the study drug, CT-010. The other group will receive a placebo.
Adults who receive the study drug will receive various doses throughout the study. All patients will be monitored for safety and tolerability.
After the study is completed, both groups will have the opportunity to try the study drug. They will not be told what groups they were in until the last patient has completed the study.
What is a Clinical Study?
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. ClinicalTrials.gov includes both interventional and observational studies.
Clinical Trials
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators give patients investigational medicines and then measure certain outcomes in the participants, which is used to learn more about the safety and efficacy of the investigational medicine.
Clinical trials used in drug development are sometimes described by phase. These phases are defined by the regulatory agencies.
*National Library of Medicine (NLM) and ClinicalTrials.gov. (2019, March) Learn About Clinical Studies. Retrieved October 3, 2019, from http://www.clinicaltrials.gov/.