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Clinical Trials

Ongoing Research Studies

Arise

Balance Therapeutics has announced the launch of the first double-blind, placebo-controlled, crossover, multicenter study of a drug (BTD-001) for the treatment of idiopathic hypersomnia (IH) and type 2 narcolepsy (T2N) in adults. More than 20 study sites throughout the United States are currently prescreening or screening people with IH and T2N for enrollment, with some sites already having enrolled participants. Additional sites are on target to begin enrolling participants in the coming months. If you are interested in finding out more about this study, please visit http://www.arisestudies.com/ or view the study on clinicaltrials.gov.


BUNIHPPS – An Online Research Survey for Narcolepsy & IH Patients

http://www.facebook.com/BUNIHPPS

A research team at Boston University has developed BUNIHPPS — a survey research study for patients with narcolepsy and idiopathic hypersomnia. Also called the Boston University Narcolepsy and Idiopathic Hypersomnia Patient Perspectives Study, BUNIHPPS is an anonymous online survey forging into new frontiers by asking patients about their experiences with symptoms, the diagnostic process, and their attitudes and behaviors. Dr. William DeBassio, a pediatric neurologist, and Sara Kowalczyk, a doctoral student at Boston University, are the study investigators.

To participate, or to learn more about participating, go to: http://www.facebook.com/BUNIHPPS

To take part in BUNIHPPS and answer the survey questions, you:

  • Must be aged 18 years or older
  • Must have a diagnosis of narcolepsy (any type) or idiopathic hypersomnia
  • May have other diseases or medical conditions
  • Must be able to read and understand English
  • Must have access to a computer connected to the Internet

You can answer the survey questions online and anonymously – no one will be able to track your answers back to you. Even though you might hear about the study in more than one way (for example, on Facebook, from an email sent to you, and through your narcolepsy doctor’s office) please participate one time. Participation began on October 10, 2015 and will stop as soon as enough participants have completed the survey. Upon completion of the survey study, participants will have the option to enter a raffle drawing for one of eight $25 Amazon gift cards. Results from the study will be published in medical journals and/or shared with patient groups during 2016.

If you have questions about this study, have trouble with the study link, or want a copy of the questions before participating, please email or leave a message for Dr. DeBassio at (questions only). Your questions will be answered within two (2) business days. There is also an option to mail in the survey for those who need it.


The TONES Study

Excessive sleepiness can catch up with you anywhere.

Adults struggling with Excessive Sleepiness due to Narcolepsy can help evaluate an investigational product.

Doctors are currently conducting the TONES medical research study of an investigational product to treat sleepiness and to help you stay awake. They want to evaluate its effectiveness against excessive sleepiness when it is taken once a day for 12 weeks.

To pre-qualify for the TONES study, you must be:

  • Between 18 and 70 years of age
  • Diagnosed with narcolepsy
  • Sleeping at least 6 hours a night

All study-related visits, tests, and investigational product will be provided to you at no cost. In addition, reimbursement for study-related time and travel may be provided.

To learn more, please contact:

Ronna Harris, RMA, CCRC
Clinical Research Manager
NeuroTrials Research Inc.
1100 Johnson Ferry Rd. Ste. 420
Atlanta Georgia 30342
Phone:
Fax:

www.neurotrials.com

Additional study sites located throughout the United States are also recruiting participants for the TONES study. More information is available at www.tonesstudy.com or at clinicaltrials.gov.


Research Opportunity

Victoria University, Melbourne Australia is commencing a study about the general health and well-being of people within three groups. One group will be those with both narcolepsy and cataplexy. Cataplexy is a sudden loss of muscle tone, often triggered by emotional arousal. Another group will be people with either narcolepsy-without-cataplexy or idiopathic hypersomnia. The third group will have no disorders of excessive daytime sleepiness. This project is part of a PhD by Samantha Gauci (under the supervision of Prof. Dorothy Bruck and Dr. Warwick Hosking). One question is whether the presence of the cataplexy symptom in narcolepsy is associated with a different level of general health and well-being (and some symptoms such as pain and migraines). If you would like to participate please go to the following website and follow the instructions for the study “Health and well-being in those with and without a disorder of daytime sleepiness”at www.facebook.com/sleep2015.

Please note: If you would rather complete the paper and pen version of the questionnaire or have any questions, please email Samantha Gauci at


Additional research studies may be available at clinicaltrials.gov.

Participating in a Clinical Trial:  Frequently Asked Questions

If you are thinking about taking part in a clinical trial or research study and would like to know more about what this means, check out the list below. We strongly recommend that you also speak with the person responsible for the study (known as the primary investigator or PI) or the study coordinator about any questions you might have that are specific to their trial.

What is a clinical trial?
A clinical trial is a type of research study in which researchers test new ways to prevent, screen for, diagnose, or treat a disease. In these FAQ’s, we will discuss clinical trials that are investigating treatments for a disease or condition. In a clinical trial, new treatments (such as drugs, devices, or procedures) are tested, or existing treatments are tested in new combinations or for new uses. The purpose of a clinical trial is to determine if a treatment is safe and/or effective. Some trials also look at other outcomes, such as change in quality of life.

What is the difference between a clinical trial and a research study?
All clinical trials are research studies, but not all research studies are clinical trials. Research studies may be observational – they might simply watch a group of people who have been exposed to something to see if it causes disease in the future, or they might follow patients with a specific disorder over time. Clinical trials involve human beings. Other research studies may involve animals, basic research at the cellular level, or other types of research that don’t involve the testing of a treatment in people. New treatments are first tested in animals or in other ways before being tried in humans.

What is a study protocol?
The protocol is the plan of action for a clinical trial, and it is set up to answer a series of questions that the researchers developed. Study protocols typically outline:

  • The reason that the study is being performed
  • Who will take part in the study (the eligibility criteria)
  • How many participants will be needed
  • What the participants will be doing
  • The schedule of tests, procedures, or drugs and their dosages
  • How long the study will last
  • What the researchers will be measuring and what information will be gathered from participants

What is randomization or a randomized controlled trial?
Some trials test a single treatment in all participants. Others separate the participants into one or more groups and test the treatment against another drug or against a placebo (a substance that looks like the treatment being studied but that has no active ingredient). When participants are assigned to different treatments, it is important that this occurs without bias, which is why treatment assignments are done randomly. Randomization is essentially a coin toss to determine who will receive the treatment being studied and who will receive the placebo (sham treatment) or other treatment (active comparator). These groups are often known as arms of the study. The people who receive the treatment being studied are in the active arm, and the others are in the control arm. When there is no approved or available treatment for a condition, the active arm receives the treatment being studied, and the other group receives a placebo. When a treatment that is considered to be a standard of care for a condition, the active arm again receives the treatment being studied, but, in this case, the control group receives the standard treatment.  There are also variations in study design that allow each participant to receive both placebo and active drug for a defined period of time.  These studies are called “crossover” studies. In these types of studies, the order in which people receive the different treatments is determined randomly, and the responses participants have to each of the different treatments are compared.

What is meant by the term blinding?
In a blinded study (actually masking or masked is a better but infrequently used term), the participants, the researchers, or both do not know to which arm a given participant is assigned. When neither the participants nor the researchers know the assigned group, the study is said to be double-blind.  This helps minimize the chance that bias will affect the results of the study.

What is an Institutional Review Board?
An Institutional Review Board or IRB is a group of people (scientists, statisticians, and members of the general public) who review study protocols to ensure that participants are kept safe and treated ethically and that the benefits of participating in the study are proportionally higher than the risks. Academic medical centers (doctors or hospitals associated with universities or medical schools) typically have their own IRBs, but there are also commercial IRBs that charge a fee to review study protocols, which are subsequently and typically conducted outside of academic medical centers. Institutional Review Boards also review and approve consent documents used in each clinical trial.

What is meant by informed consent?
Informed consent is the process by which you learn about a given research study in which you might choose to participate. The study coordinator, the doctors or scientists involved in the study, or nurses will explain all aspects of a clinical trial to you in terms that you can understand. After talking with you, they will give you a printed version of this information, which you should carefully review. Once you are comfortable that you understand all of the information presented to you and have made the decision to take part in the study, you sign a consent form. This form is not binding, however. At any time before or throughout the study, you can stop taking part in the trial (that is, you can withdraw consent) without penalty to you.

Are there any safeguards other than informed consent that protect research participants?
The first round of safeguards involves the Institutional Review Board. In addition, the federal government regulates most clinical trials that take place in the United States through the Office of Human Subjects Research Protection and the Food and Drug Administration.  The research institution in which the study takes place – whether a university medical center, private hospital or doctor’s office, or some other setting – should also oversee the safety of the participants. Finally, each protocol should include ongoing plans for monitoring the data that are gathered in the trial and for tracking participants’ safety.

Why should I participate in a clinical trial?
People decide to take part in a clinical trial for any of a number of reasons. Most studies need healthy people to participate in trials early in the process to test the safety but not the effectiveness of a treatment. For others, perhaps there is currently no treatment for their medical condition or the available treatments are ineffective and they want to have a chance at being in the arm of the study that receives the new treatment. Some people participate in clinical trials for altruistic reasons—they simply want to help others with their condition. For example, a person with a disease might currently have their symptoms under good control with their current drug regimen, but a new treatment is being studied in a clinical trial. They might have to stop their current treatment to take part in the new study, but they do so with the intention of helping to make a new treatment available for others.

Who pays for clinical trials?
Pharmaceutical companies, academic medical centers, nonprofit organizations and foundations, the National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Veterans Affairs, physicians, other health care providers, and other individuals can all sponsor clinical research.

How do I find out about what clinical trials are available?
Many clinical trials in the United States are registered at clinicaltrials.gov. The Food and Drug Administration requires registration for all interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial (1) has one or more sites in the U.S; (2) involves a drug, biologic, or device that is manufactured in the US (or its territories); or (3) is conducted under an investigational new drug application or investigational device exemption. In addition, most medical journals now require, as a term of publication, that the clinical trial had been registered at a publicly available site such as clinicaltrials.gov.  Be sure to explore research studies currently looking for participants with idiopathic hypersomnia, Kleine-Levin syndrome, and narcolepsy. It may also be helpful to use the more generic search term “hypersomnia.” Also, if you are interested in a clinical trial treatment that is not available where you live, a company like WEP Clinical may be able to help you access this treatment.

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