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Clinilabs, Inc. Paid Clinical Trial on the Efficacy and Safety of Lemborexant with Insomnia Disorder in New York, NY

Clinilabs, Inc.

Eisai is studying a drug called lemborexant or E2006, being developed to potentially treat people with insomnia disorder. The main goal of this study is to compare the effectiveness of two strengths of lemborexant with another drug called zolpidem tartrate extended release tablets (also known as Ambien® Controlled Release tablets) and placebo.

Phase: III

Health Conditions: Sleep Disorders, Insomnia

Please reference # E2006-G000-304

Sponsored by: Clinilabs, Inc.

Stipend: $250 – $1750

Length of Study: 10 Weeks

Additional Qualifying Information / Important Inclusions or Exclusions: 

Gender: Both

Age: 55 – 100

  • Males age 65+ and Females age 55+

  • Insomnia compliant 3 or more times a week

  • Habitual bedtime between 9:00pm and Midnight

Washout Period: 30 Days from Completion Date to screening

In-patient or stay overnight at the research center?: Yes

 

Once the site staff has fully explained the study, and you have agreed to participate and you have signed this consent form, you will undergo screening tests and enter a screening period where you will be assessed for eligibility. The screening period will take about 2-3 weeks. First, you will be asked about your general health, sleep history and medical history. You will also be asked about any prescription and over-the-counter drugs, vitamins and supplements you use right now or have used within the past 3 months. There are a number of other questionnaires and tests that you will complete during the screening period.

Starting after the screening visit and throughout the study, you will complete a daily electronic sleep diary on a handheld device within one hour of awakening. The diary will include questions that relate to how you slept, morning sleepiness and alcohol consumption. At a second screening visit, the study staff will review your sleep diary entries and will conduct some additional tests to see if you are still eligible. If you are, you will have an overnight sleep study. After this sleep study (also called a polysomnogram or PSG), if you continue to remain eligible, you will enter the dosing phase. During the dosing phase, you will receive study drug for approximately 6 weeks and have 6 overnight sleep studies in the clinic, 2 nights in a row for 3 times during the study. You will be randomly assigned (like the flip of a coin) to one of four study groups.

Clinilabs, Inc. in New York, NY, United States.

423 West 55Th Street, 4Th Floor New York, NY 10019 Tel. (212) 994-4567

 

Study Scavenger Provides the Below Helpful Information

About the Health Condition: Insomnia

Insomnia (in-SOM-ne-ah) is a common sleep disorder. People who have insomnia have trouble falling asleep, staying asleep, or both. As a result, they may get too little sleep or have poor-quality sleep. They may not feel refreshed when they wake up.

Insomnia can be acute (short-term) or chronic (ongoing). Acute insomnia is common and often is brought on by situations such as stress at work, family pressures, or a traumatic event. Acute insomnia lasts for days or weeks.

Chronic insomnia lasts for a month or longer. Most cases of chronic insomnia are secondary, which means they are the symptom or side effect of some other problem. Certain medical conditions, medicines, sleep disorders, and substances can cause secondary insomnia.

In contrast, primary insomnia isn’t due to medical problems, medicines, or other substances. It is its own distinct disorder, and its cause isn’t well understood. Many life changes can trigger primary insomnia, including long-lasting stress and emotional upset.

Insomnia can cause daytime sleepiness and a lack of energy. It also can make you feel anxious, depressed, or irritable. You may have trouble focusing on tasks, paying attention, learning, and remembering. These problems can prevent you from doing your best at work or school.

What Are the Signs and Symptoms of Insomnia?  The main symptom of insomnia is trouble falling or staying asleep, which leads to lack of sleep. If you have insomnia, you may:

  • Lie awake for a long time before you fall asleep
  • Sleep for only short periods
  • Be awake for much of the night
  • Feel as if you haven’t slept at all
  • Wake up too early

The lack of sleep can cause other symptoms. You may wake up feeling tired or not well-rested, and you may feel tired during the day. You also may have trouble focusing on tasks. Insomnia can cause you to feel anxious, depressed, or irritable.  If insomnia is affecting your daily activities, talk with your doctor. Treatment may help you avoid symptoms and problems related to the disorder.  –  National Institute of Health

Screening Visit

Screening Visit:  Potential candidates for a Study will participate in an initial screening visit to determine if they are appropriate for the Study.  When you first attend the screening visit for phases I-III, the study is explained in detail and you can ask any questions. If you decide to participate, the study nurse will review the informed consent form with you and ask for your signature and permission to proceed with the screening evaluations. –  –  National Institute of Health

In-Patient/Out-Patient Explained

There are two main reasons clinical research trials are done in an isolated inpatient setting where the patient stays overnight at a research clinic: 1) To protect the study participant:   Some study agents, usually challenge products, can make some people quite sick.  Study participants stay on the inpatient unit to receive 24 hour nursing care during these types of studies. Participants stay on the isolation unit until their laboratory test show they are no longer shedding the infectious agent.  2) To protect the public:  An infectious study agent that is given to a study participant may be harmful to the general public’s health.  Therefore, study participants stay on the inpatient unit until the possibility of giving the infection to someone else has passed.

An outpatient vaccine trial is a study that does not require an overnight stay in the hospital or research clinic.  Participants are given an investigational agent and have scheduled clinic visits to monitor how well they tolerate the investigational agent. Most studies require the clinic staff to follow up with subjects on a daily, weekly or monthly schedule.  Clinic visits can range from 2 to 4 hours, depending on the study and the type of visit.  –  National Institute of Health

Washout Period Explained

A period during a clinical trial when the trial subjects receive no active medication. The wash-out period is typically used to generate patient baseline data.   Every clinic has a washout period during which you are not allowed to do a study at the same clinic or any other clinic.

The minimum period is 30 days since last dose, however some washouts go based on last study procedure (such as out patient visits or how much blood you gave during the study).   The washout period may vary from study to study depending on the half-life of the drug. Certain studies like radio-labeled drugs will have a 1 year washout before you can do another radio-labeled drug.   In addition to the clinic’s washout policy, the sponsor may impose a longer washout period.  Some studies will have a longer washout before you can sign up.

In general, you can sign up and screen for another study during the washout period as long as the check in date is at least 30 days after your last dose in the previous study.  However, depending on how fast your body recovers from a study, you may want to wait the full period to avoid problems with screening.

People who screen too soon after a study typically have lower red blood cell, hemoglobin, hematocritand iron.  If these levels are too low, you could get banned from participating in studies because having low levels is unhealthy and unsafe for participating in a study.

Be forewarned that many clinic participate in the VCT (Verified Clinical Trials) program which tracks when you do a study to ensure the next study meets washout periods.  I do not mention these clinics because it shouldn’t matter.  You know the rules and if you break them, the consequences can be dire like being banned from a clinic.  Sometimes the only way to drive this message home is to allow people to find out the hard way. –  –  National Institute of Health