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Clinical Trials

 

Are you pregnant and have epilepsy?

What: The purpose of this observational research study is to establish the risk for problems during pregnancy for women who have epilepsy and determine the factors or contributions to those risks. In addition, the children of these women with epilepsy will be evaluated to determine possible cognitive adverse effects from seizures or medications.

Who: Women 18 to 45 years old who are currently pregnant in their first trimester, have epilepsy and do NOT have any active drug or alcohol abuse or major medical disease such as cancer.

Pay: Participants will be paid for study related time and travel.

For more information, contact Lucy Mendoza at lucy.mendoza@uc.edu or 513-558-3020 or CLICK HERE.

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Cincinnati Children’s Hospital is recruiting children with epilepsy who are 6-11 years old to participate in a research study exploring sleep difficulties and seizure control. This is a research study to find out whether giving a dietary supplement to children with epilepsy helps to improve micro-arousal’s, sleep quality, and provide better seizure control.

What is involved?

We will identify if your child is at risk for disturbed sleep by questionnaires. We will do a sleep study on your child. Then, your child will be asked to take either a sugar pill or the dietary supplement. We will repeat a sleep study. Then your child will take the dietary supplement if they were on the sugar pill before and vice versa. We will repeat the sleep study. At the end of the study, we will be able to identify if your child has these micro-arousals, based on the sleep study, and if the dietary supplement works for your child. If it works, he/she may continue to take it.

We will also measure your child’s behavior and attention and let you know if there is improvement with the supplement. We will ask you to keep a seizure diary, and we can identify if the supplement made any improvement in your child’s seizures.

This study will last approximately 13 weeks and include 4 study visits.

What are the benefits?

It is possible that the study medication may improve your child’s sleep and seizure control. However, there may be no direct benefit from being in this study. If there are any sleep disorders identified during the study, such as sleep apnea, the study doctor will discuss the results with you and refer your child for further evaluation.
The information learned from this study may benefit other children with epilepsy in the future.

Will I get all the facts about the study?

Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the reimbursement, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed the form.

Do participants receive pay, compensation or reimbursement?

Participants will receive $500 for their time and travel, if all procedures and visits are completed.

Contact: Twila Rogers at Cincinnati Children’s Hospital Medical Center( twila.rogers@cchmc.org or 513-636-0599)

Principal Investigator: Sejal Jain, MD, Neurology, Cincinnati Children’s Hospital Medical Center

Go to Cincinnati Children’s Hospital Medical Center page for this study.

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Lennox-Gastaut Syndrome Study

A new clinical research study is being conducted in your area to determine the effects of a potential new treatment, clobazam, in children and adults with LGS or those who experience LGS symptoms. Participation in a clinical study can help researchers learn more about the disease and can allow patients to gain access to medical care directly related to the study.

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Atkins Diet Protocol

Adult IRB# 04-02-27-08
Pediatric IRB# 05-01-26-05
Primary investigator, Dr. Eric Kossoff, 410.614.6054

This trial is now in the research phase for teens and adults. The investigators use the Atkins diet to induce benign dietary ketosis and monitor the effect of the Atkins diet on seizure control. Children as young as 8 years of age can participate.

Inclusion Criteria:

  • 1 or more seizure(s) per week (any type)
  • 2 or more medications tried
  • Can’t have kidney, heart or cholesterol disease
  • Can’t have major psychiatric disorders
  • Can’t have tried ketogenic diet in the past year
  • Willing to make 4 trips over a 6-month period
  • Labs, clinic visits and dietitian are free (for adult patients)

http://www.hopkinsmedicine.org/neurology_neurosurgery/specialty_areas/epilepsy/clinical_trials/