If you participate, the RESET clinical research study may take place during a future sickle cell pain episode that requires you to be hospitalized.
You will not need to change how you treat your sickle cell pain at home and you will still get whatever pain medication you need while you are in the hospital. If your medical history makes you eligible for participation in the study and you decide to enroll, the total study duration will be approximately 44 days from the time of hospitalization for a pain episode. If enrolled, you would receive the investigational study drug or inactive placebo for a maximum of 8 days and, once your pain episode resolved, you would be discharged from the hospital.
Following your discharge from the hospital, the rest of the time on the study would include a 35-day follow-up period during which the study team would call and check on you a couple of times. At the end of this follow-up period you would need to come in to the study site for a follow up visit—this would be about 35 days after you had been discharged from the hospital following your pain episode.
If you take part in the study, you will receive study-related medication (or placebo) and study-related procedures and assessments at no cost to you or your insurance company. If necessary, transportation to the hospital where the study is being done will also be provided at no cost.
You will be hospitalized while receiving the study drug (or placebo) and will be under medical supervision. Your safety will be the priority. Your health will be carefully monitored and the study treatment will be stopped if you or the study doctor have any concerns, or if you change your mind about participating in the research study.
How Does the Study Drug Work?
The study drug for the RESET clinical research study is not a narcotic or opioid pain reliever. It may help relieve the reduction of blood flow that is known to lead to sickle cell pain episodes.