The STARS Study is testing an inhaler containing an investigational drug to see whether it could help people who experience prolonged epileptic seizures. Two versions of the inhaler will be compared in this study: one version will contain the active investigational drug; the other version will contain a placebo. Both versions of the inhaler look identical, but the placebo version contains no active medication. All participants must collaborate with a study partner to assist them throughout the study.
The STARS Study will last up to approximately 19 weeks and is made up of 3 parts:
- Part 1: Screening (6 weeks) – If you are interested in taking part, you will visit the nearest study site twice to have tests. The results of these tests will show whether you and your study partner are able to take part.
- Part 2: Study treatment (12 weeks) – If eligible, you will be given an inhaler containing the study drug (investigational drug or placebo) to take during 1 qualifying prolonged seizure, if experienced. During this period, you may have tests at the study site or your home. The study staff will also call you every week to check on your health.
- Part 3: Follow-up – If the inhaler was used, return to the study site for health checks 5–12 days later. If the inhaler was not used, return to the study site 5–12 days after the study treatment period ends.
A computer will randomly assign you to your study drug. You will have a 50% (1 out of 2) chance of receiving the investigational drug and a 50% chance of receiving placebo. You cannot choose which study drug to receive. Neither you nor the study staff will know which study drug you are receiving (although if it is medically necessary to find out, the study doctor can do so quickly). This ensures that results from the tests are handled in the same, unbiased way.
After your final follow-up visit, you and your study partner may have an opportunity to join the STARS Extension Study, during which all prolonged seizure participants will receive the investigational drug for up to approximately 4 years. The purpose of the STARS Extension Study is to assess the safety and effectiveness of the investigational drug over a longer period.
What happens during the study?
Various tests and assessments will occur during the study, including (but not limited to) the following:
A sample is collected by inserting a small needle into a vein in your arm.
The study doctor will check your appearance, and also listen to the sounds of your breathing. You will also have your height and weight measured.
A machine records your heartbeat through patches attached to your chest, arms and legs.
Your temperature, blood pressure, oxygen levels, pulse rate and breathing rate will be measured.
You will be asked to record details about any seizures experienced.
You will answer questions about how you are feeling and how your epileptic seizures affect your life.
method of administration
Interested?Find your nearest study site