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Benzodiazepine

Valtoco for Epilepsy

Phase 1 & 2
Waitlist Available
Research Sponsored by Neurelis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-6 hours
Awards & highlights

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.

Who is the study for?
This trial is for children aged 2 to 5 with epilepsy who may need benzodiazepine treatment for seizure control. They should have had seizures that required rescue medication in the last three months or might need such intervention occasionally. Kids under 6 kg or over 33 kg, those in recent trials, surgeries, injuries, or with conditions affecting study results can't participate.Check my eligibility
What is being tested?
The study tests VALTOCO® (Diazepam Nasal Spray) to see how it's processed by young bodies and its safety as a single-dose treatment for seizures in pediatric patients. It's an early-stage trial (Phase 1/2a), meaning it's partly about checking the right dosages and initial responses.See study design
What are the potential side effects?
While not explicitly listed here, Diazepam nasal spray side effects could include drowsiness, headache, nasal discomfort, and potentially more serious effects like trouble breathing or severe dizziness which are common to benzodiazepines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age

Trial Design

1Treatment groups
Experimental Treatment
Group I: Valtoco In Pediatric Subjects with EpilepsyExperimental Treatment1 Intervention
5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.

Find a Location

Who is running the clinical trial?

Neurelis, Inc.Lead Sponsor
3 Previous Clinical Trials
256 Total Patients Enrolled
3 Trials studying Epilepsy
256 Patients Enrolled for Epilepsy

Media Library

Diazepam Nasal Spray [Valtoco] (Benzodiazepine) Clinical Trial Eligibility Overview. Trial Name: NCT05076838 — Phase 1 & 2
Epilepsy Research Study Groups: Valtoco In Pediatric Subjects with Epilepsy
Epilepsy Clinical Trial 2023: Diazepam Nasal Spray [Valtoco] Highlights & Side Effects. Trial Name: NCT05076838 — Phase 1 & 2
Diazepam Nasal Spray [Valtoco] (Benzodiazepine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076838 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~9 spots leftby Mar 2025