3. What will happen during the study and what do I and my child have to do?
The study consists of 4 visits to the study doctor’s clinic, a follow-up phone call, and daily phone calls during dosing days to discuss your child’s side effects, if any, and confirm doses were taken.
If you live more than 100 miles from a clinic site, the Rettland Foundation may be able to help with the cost of travel.
No blood draws will occur in the study. The entire study will complete from the first visit to the final follow-up phone call within 8 to 10 weeks depending on how close together study visits are scheduled.
At 2 visits, each participant will receive free of charge a bottle of medication for dosing at home. One bottle at one visit will contain 5 days of oral dosing of ketamine, and the other bottle at the other visit will contain 5 days of oral dosing of placebo. For each 5-day treatment, you will give your child 2 oral doses of study medication per day. The order in which the treatments are given is assigned by a computer and unknown by the study team. Each treatment will be evaluated by the parent and the study doctor for 2 weeks including the 5-day dosing period.
The same parent/caregiver will accompany the child to each of the 4 in-clinic visits that occur approximately every 2 weeks. 2 visits will be about 3 hours long where your child will be observed after dosing for 2 hours to ensure her safety before continuing dosing at home. Site sites may perform an EEG (a measure of brain activity by placing a special cap on your child’s head) at these 2 in-clinic dosing visits.
The same parent/caregiver will evaluate and complete questionnaires about their child’s symptoms at each visit, 2 times at home, and on the follow-up phone call.
Your child will wear 2 wearable sensors every day during the study to collect data on how her body works including her heart and breathing, motion and sleep. One sensor, the actigraph, is worn like a waterproof watch and only removed for data transfer at the study site. The other sensor, the hexoskin shirt, is a tank top that will be worn continuously but will be removed daily for a few hours break, and to charge the device at home and upload data. 2 shirts are provided so one shirt can be worn while the other can be placed in the washing machine at home when needed.
Dose your child twice a day on each of the 5 dosing days for each treatment, speak with the study site to discuss your child’s side effects, if any, and confirm doses were taken on each dosing day and the day after dosing.
Bring the 2 wearable sensors and used study drug bottle to each in-clinic visit.