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 31 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 or Idiopathic Hypersomnia Clinical Trial: Patients ages 18-75, with Narcolepsy or Idiopathic Hypersomnia (IH). This study is looking at the effect of a medicine known to improve sleepiness in patients with Narcolepsy or IH who have access to their previous test results confirming the Narcolepsy or IH. The study lasts about 15 weeks, with up to 6 office visits, 2-3 overnight stays, and 8 telephone calls. This is an open label study, so patients get active medicine for sure. Patients may stay on previous medicines for Narcolepsy or IH if they are still excessively sleepy on them. We pay up to $3000-4000 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 diagnosed Idiopathic Hypersomnia (IH), or a clinical history strongly indicative of IH. If necessary, we will do testing to confirm IH. This study looks at the effect of a new medicine on sleepiness in patients with IH. The study lasts about 10 weeks, with 8 office visits. This starts as an open-label study in which everyone gets active medicine. If patients do well on this medicine, there is a 2 week period during which they may get medicine or placebo. We pay up to $1135 for the subject’s time and expenses upon completing the study.
- Obstructive Sleep Apnea Clinical Trial with Medicine: Patients age 18 or older, with diagnosed Obstructive Sleep Apnea and tiredness/ fatigue. Patients must not be able or willing to use CPAP and must not have used CPAP in the past three months. They must have normal blood pressure or blood pressure well controlled with medicine(s). The study lasts a year and involves 9 visits (including 4 overnight visits with sleep testing) and a few telephone calls. We pay up to $1750 for the subject’s time and expenses.
- Insomnia with Hot Flashes Clinical Trial for Menopausal Women: Women age 45-65 years, with at least 20 moderate to severe hot flashes a week and difficulty staying asleep (awake at least 30 minutes in the middle of the night). Must have no menses for at least 12 months or following removal of both ovaries. This study looks at the effect of a new medicine on sleep in menopausal women with hot flashes and insomnia. They must not be taking any hormone replacement or treatment. Medicines for anxiety, depression or sleep are not allowed during the study. The study will last about 4 months. There are 8 visits including 6 overnight visits. We pay up to about $2600 for the subject’s time and expenses.
Clinical trials come and go, and they fill up fast. Please click here to see if we are currently recruiting for any trials.