About this Research Study:
To pre‐qualify for this study, all eligible participants must:
- Be between 18 and 75 years old.
- Have been diagnosed with a TBI for 6 months or more.
- Have a history of aggression, agitation, or irritability that was not present before the TBI.
- Have a reliable caregiver who interacts with the patient at least 2 hours a day for at least 3 days a week.
There are additional criteria that are reviewed on this website, and by the study team at the study center at the first visit, if you pre-qualify.
This TBI Study involves attending study appointments, completing study procedures, taking the study drug (investigational drug or placebo), and reporting on the study participant’s behaviors.
This initial appointment is an opportunity for you to:
- Learn more about this TBI Study. You’ll be speaking with a study coordinator at the study center to learn more regarding potential participation.
- Ask any important questions you may have. These can be any questions you may have about this TBI Study or clinical research in general.
- Determine if this TBI Study may be right for you. After speaking with the study coordinator and learning details about this study, the research staff will review additional study criteria to determine eligibility. If eligible, the potential participant will be given an opportunity to decide if participation is right for them. The center will ask eligible participants to review and sign a consent form.
Eligible participants will be in this TBI Study for about 4 months. There will be 6 visits to the study center, and 2 phone call visits.
The investigational drug being studied in this TBI Study is a capsule taken orally.
There’s a 50% chance of receiving the investigational drug, and a 50% chance of receiving a placebo. A placebo looks like the investigational drug but contains no active medication.
Study participants, their study partners, and the study doctors will not know which study drug (investigational or placebo) the participant is receiving.
Please do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician.
Health and safety are always top priority of clinical research study centers and there are many precautions in place to help keep you safe. Here are some of the precautions study centers are taking.
- Assessing COVID-19 symptoms upon arrival.
- “No touch” thermometers to make your appointment as safe as possible.
- Requiring all staff and patients to wear masks.
- If you have COVID-19 symptoms, offices will ask that you do not arrive at the doctor’s office before first speaking with someone in the office. Many offices are equipped to do video visits.
- Virtual study visits.
- Physician distancing.
- Cleaning and disinfecting waiting rooms and exam rooms.
- E-check ins for patients – which enables you to check in from the parking lot and be contacted when an exam room is open to decrease the time you have to spend in waiting room.
The study centers are located throughout the United States.
All study‐related visits, tests, and study drugs will be provided at no-cost. In addition, reimbursement for study‐related travel may be provided.
This research study is designed to test the investigational drug for safety and effectiveness. One or more of the answers that you provided were outside of the eligibility criteria for this study. This does not mean you will not qualify for different research studies.
About Research Studies:
A research study (also known as a clinical trial) is a medical study that is designed to answer questions about the safety and efficacy of potential new drugs or procedures and to find out how well they work. These studies must be performed before a potential new medication or treatment can be approved for use in patients.
It is important to test drugs and medical devices in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments.
For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Participants will be selected based on the eligibility criteria and the number of participants needed by the researchers.
Research studies are used to test medications before they are sold to the general public. The testing that takes place during the studies provides information regarding the safety and effectiveness of the potential medication.
One way to find information about clinical trials is by searching this website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial’s purpose, who is qualified to participate, locations, and phone numbers to call for more information.
For those who are qualified, taking part in research studies offers benefits:
- Getting actively involved in their own health care.
- Having access to investigational research treatments.
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because each individual may respond differently to treatments.
For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.
Research studies can be sponsored by an organization such as a pharmaceutical company, a federal agency such as the Veterans Administration, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, doctor’s offices, and/or at hospitals.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the study. Participants must sign an “informed consent” form before joining the study, indicating they understand that the study is research, and that they can leave the research study at any time. This informed consent helps ensure that a prospective research study participant understands what is involved.