Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
INSYS Therapeutics Inc
Age
1–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Completed activities through Day 11 in INS011-14-029 or Part A (Visit 6) INS011-15-054
Informed consent/assent (as applicable) was voluntarily provided by the participant and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and local requirements
Is medically stable with no anticipated changes in chronic medications in the opinion of the Investigator
Continues to meet protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder
In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able to continue keeping accurate seizure diaries
You may not be if
Inadequate supervision by parent(s)/caregiver(s)
History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
1. the safety or well-being of the participant or study staff
2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
