What is the Investigational Study Drug?
An investigational drug is a drug that has not yet been approved by the US Food and Drug Administration (FDA) to be prescribed by doctors.
The investigational study drug in the X-TOLE study is called XEN1101. It is a novel, selective KV7 potassium channel modulator. It is administered orally as a capsule and is to be taken once daily. It is also recommended to take the drug in the evening to reduce known central nervous system effects, such as dizziness and sedation consistent with this class of drug.
The placebo is also a capsule and looks identical to the XEN1101 but does not contain any drug. It is administered in the same manner as the investigational study drug. It is used in this research study to determine if XEN1101 is more effective than no treatment at all. If you participate in the X-TOLE Study, there is a 1 in 3 chance of receiving placebo. If you are in the placebo group, you may not receive any benefits from the study treatment; however, you may be eligible to participate in the open-label extension period of the study and receive active study drug for up to 1 year.
XEN1101 is an investigational drug and is not available for commercial sale worldwide.
To see if you are eligible for this study, Click Here.