Do you have stress, anxiety, or nightmares due to a traumatic event?

What is the IMPACT-2 Study? A clinical trial exploring the effect of an investigational oral medication for PTSD symptoms.

Who can participate? People who have experienced a traumatic event and are now suffering symptoms of post-traumatic stress disorder (PTSD).

Where? The study is being conducted at select locations throughout the US and UK.

When? Now – the study is actively enrolling new participants.

If you qualify, what can you expect from the IMPACT-2 Study?

• Evaluations of your PTSD symptoms and overall health from a local physician
• Study-related care at no cost and the potential to receive investigational oral medication
• Compensation for travel expenses.
• The opportunity to help advance PTSD research, which may benefit other people with PTSD in the future.
• Privacy: All participant’s information will remain completely confidential.

If you are dealing with stress, anxiety, or insomnia due to a traumatic event, you may qualify for the IMPACT-2 Study. See if you qualify and be connected to a participating site nearest to you by filling out a brief questionnaire.

1. What is the purpose of a clinical study?
Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by each country’s regulatory authorities. These rules help protect the rights and safety of those who volunteer to take part in clinical trials.

2. Is study participation confidential?
Yes, both your health history and participation in the study is kept strictly confidential. This includes military participants, regardless of your current service status.

3. How long does the study last? What happens at the visits?
Your total participation in the study will take 4 – 5 months, and will involve 10 – 14 visits to your local study site. If you qualify for the study, you will take the study medication weekly over a 4-week period (called the Treatment Period). The study medication will be taken at your local study site. Following the Treatment Period, you will return to your local study site 4 more times over an 8-week period for additional follow-up. At most visits, you will undergo routine safety assessments (vital signs, labwork, and ECG). Your study doctor and team will ask how you are feeling, how your symptoms of post-traumatic stress may have changed and whether or not your daily life has been impacted.

4. What if I join the study and decide I do not want to participate anymore?
As with all clinical studies, your participation is completely voluntary. You may leave the study at any time without any effect on your future medical care.

5. I am interested in possibly moving forward. What is the next step?
To see if you might qualify for the study, and to get connected with your local study centre, the next step is taking the pre-screening questionnaire. Please click here to get started.

Many people will experience a life-threatening traumatic event in their lifetime, including but not limited to:

• Physical or sexual assault (with or without a weapon)
• Domestic abuse
• A serious accident (in the workplace, in a vehicle, in public, etc.)
• Natural disaster
• Military/first responder traumatic events

Events such as these can trigger a range of symptoms, including:

• Flashbacks, nightmares, or trouble sleeping
• Avoiding things that bring on distressing memories
• Negative thoughts or feelings, feeling detached
• Feeling on edge or easily startled
• Feeling that normal day to day activities, relationships, and overall state of mind has changed drastically since the traumatic event

While these symptoms often go away in a few weeks, for some they never go away and linger for months or even years – a condition known as post-traumatic stress disorder (PTSD).