Participants will receive either one of two doses of the medication; (a) if more than one dose is necessary to control seizures for the duration of the study, participants will receive both doses; (b) if one dose of the medication is sufficient for the duration of the study, participants will receive the medication at one of two scheduled times during the study (restudy to 4 weeks in duration and post-study to 8 weeks in duration). Who may participate? Any child or adult who has one of the following seizures: (a) focal generalized tonic-clonic seizures with onset > 2 minutes; (b) tonic-clonic seizures only; or (c) seizure disorder with epilepsy (including pediatric or adolescent cases). How will the study be conducted? The study will be part of routine patient care. Each subject will be observed in the hospital setting. A neurologist will be seen at least once a month to determine the presence and duration of seizures during and between visits. How will the research be done: The research will be part of routine patient care and will take approximately 2 hours a week. What are the study's possible risks and benefits? The study has a number of potential risks and benefits. In this study, the use of the drug and other potential treatments for the condition of epilepsy that have been used in adults or children are currently under investigation or being evaluated for safety. The study has the potential to increase the duration and severity of seizures, which may also have a number of possible benefits. How will the drug be prescribed: Patients who want to start the study may make their own decisions about starting treatment with the agent. After patients are scheduled to start the study for any reason, they may or may not continue the study. Patients will be informed in advance of the starting schedule and can then either continue the study indefinitely, or stop it. How will the research team administer the study drug? Study medications are taken orally each morning. All medication will be given on a continuous schedule. The study agent will be administered once at 8:00 AM, and the study will run through 8:30 PM the next morning. How often patients take the study medication will depend on their seizure severity, but will be between the days at 8:00 AM and 8:30 PM. In addition, the frequency will change as the study progresses with a daily titration of the medication.
Get the free A Study to Determine the Safety and Tolerability of a Medication for ...
Show details
A Study to Determine the Safety and Tolerability of a Medication for the Treatment of Seizures Division: Pediatric Neurology Principal Investigator: Robert Gel, M.D. What is the purpose of the study?
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign
Edit your a study to determine form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share your form instantly
Email, fax, or share your a study to determine form via URL. You can also download, print, or export forms to your preferred cloud storage service.
Editing a study to determine online
Here are the steps you need to follow to get started with our professional PDF editor:
1
Register the account. Begin by clicking Start Free Trial and create a profile if you are a new user.
2
Prepare a file. Use the Add New button. Then upload your file to the system from your device, importing it from internal mail, the cloud, or by adding its URL.
3
Edit a study to determine. Rearrange and rotate pages, add and edit text, and use additional tools. To save changes and return to your Dashboard, click Done. The Documents tab allows you to merge, divide, lock, or unlock files.
4
Save your file. Select it from your list of records. Then, move your cursor to the right toolbar and choose one of the exporting options. You can save it in multiple formats, download it as a PDF, send it by email, or store it in the cloud, among other things.
pdfFiller makes working with documents easier than you could ever imagine. Create an account to find out for yourself how it works!
Fill form : Try Risk Free
For pdfFiller’s FAQs
Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
What is a study to determine?
A study to determine is a research project aimed at investigating and analyzing a specific subject or problem.
Who is required to file a study to determine?
The individuals or organizations conducting the study are required to file a study to determine.
How to fill out a study to determine?
To fill out a study to determine, you need to provide accurate and complete information about the research objectives, methods, data collection, analysis, and expected outcomes.
What is the purpose of a study to determine?
The purpose of a study to determine is to gather information, analyze data, and draw valid conclusions that can be used for decision-making or further research.
What information must be reported on a study to determine?
A study to determine should include details about the research objectives, methodology, data sources, data analysis techniques, and expected outcomes.
When is the deadline to file a study to determine in 2023?
The deadline to file a study to determine in 2023 will depend on the specific regulations or requirements set by the governing body or institution. Please refer to the official guidelines or contact the relevant authorities for accurate information.
What is the penalty for the late filing of a study to determine?
The penalties for the late filing of a study to determine can vary depending on the governing body or institution's rules. It may include fines, delayed approval process, or other consequences specified in the regulations. Please refer to the official guidelines or contact the relevant authorities for accurate information.
How can I modify a study to determine without leaving Google Drive?
Using pdfFiller with Google Docs allows you to create, amend, and sign documents straight from your Google Drive. The add-on turns your a study to determine into a dynamic fillable form that you can manage and eSign from anywhere.
Where do I find a study to determine?
The premium subscription for pdfFiller provides you with access to an extensive library of fillable forms (over 25M fillable templates) that you can download, fill out, print, and sign. You won’t have any trouble finding state-specific a study to determine and other forms in the library. Find the template you need and customize it using advanced editing functionalities.
How do I fill out a study to determine on an Android device?
Use the pdfFiller Android app to finish your a study to determine and other documents on your Android phone. The app has all the features you need to manage your documents, like editing content, eSigning, annotating, sharing files, and more. At any time, as long as there is an internet connection.
Fill out your a study to determine online with pdfFiller!
pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.
Not the form you were looking for?
Keywords
Related Forms
If you believe that this page should be taken down, please follow our DMCA take down process
here
.
