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Effects of Diazepam on RNS Detections

NCT05273398 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-04-12

No results posted yet for this study

Summary

To assess the magnitude and duration of reduction in RNS recorded Detections and Long Episodes following intranasal administration of Valtoco®. All participants will have been implanted and treated with an RNS system for clinical purposes and regularly upload Detection and Long Episode data on a regular basis as part of regular clinical treatment. Participants will come to the clinic and be administered a single dose of Valtoco® via nasal spray. RNS recorded Detections and Long Episodes before and after Valtoco® administration will be compared. This is a pilot study, so all outcomes are exploratory.

Conditions

  • Epilepsies, Partial

Interventions

DRUG

nasal diazepam

Nasal administration of diazepam

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Michael D Privitera · University of Cincinnati

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-11-10
Completion
2022-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05273398 on ClinicalTrials.gov