CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 57 enrolled
Drug / intervention
NRL-1drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02724423
NCT02724423Phase 1Completed
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An Open-Label, Repeat-Dose Pharmacokinetics Study of NRL-1 in Epilepsy Subjects Under Seizure and Normal Conditions

Neurelis, Inc.·interventional·Posted Mar 31, 2016·Updated Oct 5, 2021

In Brief

A Phase 1 clinical trial evaluating NRL-1 for Acute Repetitive Seizures. Completed, enrolled 57 participants across 4 sites.

Detailed Summary

This study evaluates the pharmacokinetic and safety of NRL-1 in epilepsy subjects. Subjects will receive a single intranasal dose of NRL-1 of either 5 mg, 10 mg, 15 mg or 20 mg and will be based on the subject's body weight.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Repetitive Seizures
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 31, 2016
Enrollment StartJun 30, 2016
Primary CompletionApr 10, 2019
Study CompletionSep 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.3 years ago

Interventions

NRL-1drug