Why is there a placebo in this study?

A placebo-designed study allows researchers to measure the effectiveness of a study drug by comparing the group on the active study medicine and the group on the placebo. After completion of this study, participants may be offered the option to move on to another study involving the study medicine (without a placebo).

Who is the study sponsor?

This study is funded by Cephalon, Inc.

Will it cost me anything to participate in the study?

No, there is no cost to the study participants. If you qualify to participate in this study, you will receive:

• Study-related tests and monitoring
• Study medicine
• Help with transportation

*Payment for time may also be provided.

Why don’t I meet the study requirements?

All clinical studies have a written research plan called a protocol that is designed to help protect the health and well-being of participants. All criteria contained in the protocol must be met in order to participate in the study.

Why was I asked about Workmen’s Compensation?

Any one who is involved with active litigation (lawsuit) or is currently receiving workmen’s compensation in relation to a head injury may not be able to take part in this research study.

Should I tell my doctor about this study?

Yes, you may wish to tell your doctor about the study, how long it will last, and the name of the doctor(s) at the study center. If you qualify for the study, you can give permission for the study-staff to follow-up with your doctor to provide additional information about your participation.

Why are there no active study centers in my area?

Study centers must meet strict criteria in order to participate in clinical studies. If there is no active center at this time, one may open at a later date. If you provide your contact information, we will be glad to contact you when the study center opens.

Do I have my choice of doctors conducting this research study?

If there is more than one study center in your area, you may choose the one you prefer when you complete the pre-screener.

Can you tell me more about the sleep lab?

Sleep labs combine diagnostic technology with a hotel-like atmosphere. The size of rooms may vary, but they all have a calming décor and a comfortable bed to help put you at ease. Some rooms may also have a writing desk, bath, recliner and television. Please note that sometimes the sleep lab may be in a different location than the study center.

What is an Informed Consent Document?

Informed consent is a process that takes place before you participate in the study. It is a discussion of procedures, benefits, and risks of the study between study doctors and potential patients.

• A study doctor, nurse or other study staff will explain the purpose of the study and what you can expect.
• You can ask any questions you have about the study.
• You will be told about who will see your personal medical information, and how it will be kept confidential.
• You will also be given a consent document to read.
• You should ask questions about any part of the consent document you do not understand.
• If you decide to take part in the study, you will be asked to sign the consent document. Even if you sign the consent document, you can still change your mind and stop participating in the study at any time.

If I begin the study and no longer want to participate, can I stop?

Yes. If at any time throughout the study you decide that you no longer want to participate; you may stop. We ask that you tell the study staff if you plan to stop. You may have to make a final study visit for your own safety and to complete the study records.

What are the risks?

As with all drugs, there can be unknown risks. The staff at the study center will discuss this during the Informed Consent Process.

I am concerned about confidentiality. Who will have access to my name and the information you are collecting?

All information for research purposes identifies you only by a number. Please be assured that the study staff will hold your name and any information you provide in confidence. This will be discussed in further detail during the Informed Consent Process.

Information entered in the online pre-screener will be stored in a secure database maintained by MediciGlobal, the host of this website. With your permission, your information may be sent to participating study centers in your area.

What is a clinical research study?

A clinical research study is a carefully controlled investigation to help determine if a medicine is safe and effective for a particular use.

What are the steps of a clinical research study?

Most clinical research that involves the testing of a study drug progresses in an orderly series of steps called phases. This allows researchers to ask and answer questions in a way that gathers reliable information about the study drug and also protects participants.

Clinical studies are usually classified into 1 of 4 phases:

Phase I Studies: These first studies in people evaluate how a new study drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A Phase I study usually enrolls only a small number of participants, sometimes as few as a dozen.

Phase II Studies: A phase II study continues to test the safety of the study drug and begins to evaluate if the drug works often compared to placebo (inactive substance). Phase II studies usually focus on a particular type of medical condition.

Phase III Studies: Phase III studies enroll large numbers of people with a medical condition and may be conducted at many doctors' offices and medical clinics nationwide and worldwide. These studies provide additional information about the safety and effectiveness of a study drug in treating the condition.

Phase IV Studies: Phase IV studies capture any additional information about how the study drug should be used or benefits and risks that has not been previously determined.

* Source: the National Institute of Health

What is the phase of this clinical research study?

This clinical research study is a Phase III study.

Why should I participate in a clinical trial?

By participating in a clinical trial, you are contributing to medical research that may help others in the future. You are helping researchers answer questions about future study treatments that may one day be available to people all over the world.