Clinical Trials for Patients
What is a Clinical Trial?
When a drug company or a device company comes up with a new drug or product, this product is extensively tested. The test results are then submitted to the Food and Drug Administration (FDA). It evaluates the results before approval for general use. During this testing process, the company uses centers known for their quality and prestige. These centers give the drug or use the device on their patients. They collect information on efficacy (how effective the new drug or device is). They also collect information on safety (is the new drug or device safe). This is called a Clinical Trial.
Why should you participate in a Clinical Trial?
- A clinical trial may give you access to a treatment not yet available to the general public.
- You help in the development of new knowledge and treatments for patients in general.
- You receive evaluation and treatment at no cost to you.
- You are paid for your time and inconvenience.
Is a Clinical Trial safe?
No guarantees can be made that any given Clinical Trial is safe. However, trials by reputable centers such as ours make every effort to maintain safety. The Clinical Trial is first reviewed and approved by an Institutional Review Board. This happens before any patients are enrolled. You are given a detailed Informed Consent. You review it before you agree to participate. You may withdraw your participation or leave the study at any time. Generally, we make every effort to make sure that any harm to you (and we have never had any significant safety issue in doing this for 22 years) is taken care of by the company developed by the new drug or product.
Do you have any Clinical Trial going on at this time?
Currently we are conducting the following Clinical Trials:
- Narcolepsy Clinical Trial: Patients ages 18-65, with Narcolepsy. This study is looking at the effect of a new medicine on sleepiness in patients with Narcolepsy who have access to their previous test results confirming Narcolepsy. The study lasts about 5 weeks, with three sleep testing stays (overnight and the next day) with us. Patients may get active medicine or placebo. We pay $1700 for the subject’s time and expenses upon completing the study.
- Idiopathic Hypersomnia Open Label Clinical Trial with Double Blind Withdrawal: Patients age 18 or older, with Idiopathic Hypersomnia (IH). This study looks at the effect of a new medicine on sleepiness in patients with IH. This starts as an open-label study in which everyone gets medicine. Patients may stay on previous medicines for IH if they are still excessively sleepy on them. who have access to their previous test results confirming Narcolepsy. The study lasts about 14 weeks, with 5 office visits and several phone calls. If patients do well on this medicine, there is a 4 week period during which they may get medicine or placebo. Patients may get active medicine of placebo. We pay $950 for the subject’s time and expenses upon completing the study. At the end of the study, patients may join an open label extension study during which they get the medicine for sure for several months.
Clinical trials come and go, and they fill up fast. Please click here to see if we are currently recruiting for any trials.
How do I participate?
Call our office at 586-254-0707, or fill out a request for us to contact you.
