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Study Summary
This trial is testing a new drug for epilepsy in young children. The drug will be given to a small group of children to see if it is safe and effective.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have not had major surgery, significant injury, or open biopsy in the last 30 days.I have epilepsy and might need benzodiazepines for seizures.I have epilepsy and might need benzodiazepines for seizures, according to my doctor.I have epilepsy with seizures that sometimes require emergency medication.I don't have any major health issues that could affect my safety or the study's results.I have epilepsy with seizures that needed emergency medication recently.My body weight is either below 6 kg or above 33 kg.
- Group 1: Valtoco In Pediatric Subjects with Epilepsy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there still an opportunity to participate in this research experiment?
"Affirmative. According to the details on clinicaltrials.gov, this medical trial is recruiting participants who can be found at 15 different sites across the United States of America. The study was launched in November 2021 and last updated in October 2022 with a goal of admitting 30 patients."
In how many disparate locations is this research taking place?
"This trial is being conducted at Massachusetts General Hospital in Boston, MA, Duke University Medical Centre located in Durham, NC and UT Southwestern Medical Center of Dallas tx. Additionally, there are 15 other sites where this medication can be accessed."
What is the total capacity that this research program can accommodate?
"Neurelis Inc. are responsible for conducting this trial, which requires 30 participants that meet the inclusion criteria. Research will be conducted at sites such as Massachusetts General Hospital in Boston and Duke University Hospital in Durham, North carolina."
Is involvement in this trial an option for me?
"This research study is recruiting 30 toddlers with aura, between the ages of two and five. Criteria for acceptance include a clinical diagnosis of epilepsy as well as the potential need to utilise benzodiazepines every three months on average in order to control seizures or changes in awareness."
What medical conditions is Diazepam Nasal Spray [Valtoco] commonly prescribed for?
"Valtoco, or Diazepam Nasal Spray, is primarily prescribed to combat sedation. However it has been found useful in treating athetosis, refractory epilepsy and various other syndromes."
Can individuals younger than 20 participate in this research endeavor?
"This clinical trial has stringent age requirements; any participant must be at least two years of age but not more than five."
Could you tell me what other research has been conducted regarding the efficacy of Valtoco Nasal Spray?
"As of the present moment, there are 5 studies underway evaluating Diazepam Nasal Spray [Valtoco]. None of these trials have advanced to Phase 3. Although most clinical sites participating in this trial are located in Ratchathewi, Bangkok, a total of 19 medical centres around the world are running research for this intervention."
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