Clinical Trial 49237

Miami, FL 33155


Summary:

To monitor for potential chronic liver injury and liver fibrosis, in participants prescribed Epidiolex.

 



Criteria:

1. Participant is within the approved age range as per labeling recommendations.
2. Participant is either on existing Epidiolex therapy for treatment of a seizure disorder or is to be started on Epidiolex for treatment of an FDA-approved indication.
3. Participant and/or parent(s)/legal representative must be willing and able to give informed consent/assent for participation in the study.
4. Participant and their caregiver must be willing and able (in the investigator’s opinion) to comply with all study requirements.
5. Participant and/or parent(s)/legal representative is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
6. Participant is willing to refrain from strenuous exercise 48 to 72 hours prior to all study visits with the exception of unscheduled visits.
7. Any non-pharmacological therapies (e.g., ketogenic diet) must also be stable up to 4 weeks prior to Screening Visit and expected to be stable throughout the duration of the study.


Qualified Participants May Receive:

Up to $1000.00


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.