Trial · NCT02721069

Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects

NCT02721069, Phase 3, Completed, Neurelis, Inc.; results first posted 2022-01-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects. Trials, record NCT02721069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02721069

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects
NCT number: NCT02721069
Status: Completed
Phases: Phase 3
Enrollment: 175 participants, actual
Lead sponsor: Neurelis, Inc.
Conditions: Acute Repetitive Seizures, Breakthrough Seizures
Interventions: NRL-1
First posted: 2016-03-28
Last updated: 2022-01-31
Results first posted: 2022-01-31

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Who Received NRL-1 (Valtoco)	12 months	Assess the number of participants who received at least one dose of NRL-1 (Valtoco) during the study and comprised the safety population.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Received NRL-1 (Valtoco)	12 months	Subjects who received at least one dose of NRL-1.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants Who Received NRL-1 (Valtoco)	NRL-1 5mg	9	Participants
Number of Participants Who Received NRL-1 (Valtoco)	NRL-1 10mg	54	Participants
Number of Participants Who Received NRL-1 (Valtoco)	NRL-1 15 mg	46	Participants
Number of Participants Who Received NRL-1 (Valtoco)	NRL-1 20mg	54	Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NRL-1	175
Overall Study	COMPLETED	NRL-1	117
Overall Study	NOT COMPLETED	NRL-1	58

Source ClinicalTrials.gov

Adverse events252

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	NRL-1 5mg	1	9	3
other	Nasopharyngitis	Infections and infestations	NRL-1 10mg	12	54	13
other	Nasopharyngitis	Infections and infestations	NRL-1 15mg	3	46	3
other	Nasopharyngitis	Infections and infestations	NRL-1 20mg	4	54	6
other	Upper Respiratory Tract Infection	Infections and infestations	NRL-1 5mg	0	9	0
other	Upper Respiratory Tract Infection	Infections and infestations	NRL-1 10mg	9	54	10
other	Upper Respiratory Tract Infection	Infections and infestations	NRL-1 15mg	7	46	8
other	Upper Respiratory Tract Infection	Infections and infestations	NRL-1 20mg	4	54	4
other	Influenza	Infections and infestations	NRL-1 5mg	3	9	4
other	Influenza	Infections and infestations	NRL-1 10mg	5	54	5

1 to 10 of 252Source ClinicalTrials.gov

See all 252 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NRL-1 5mg	0	9
Total, all-cause mortality	NRL-1 10mg	0	54
Total, all-cause mortality	NRL-1 15mg	0	46
Total, all-cause mortality	NRL-1 20mg	1	54
Total, other adverse events	NRL-1 5mg	6	9
Total, other adverse events	NRL-1 10mg	34	54
Total, other adverse events	NRL-1 15mg	24	46
Total, other adverse events	NRL-1 20mg	21	54
Total, serious adverse events	NRL-1 5mg	2	9
Total, serious adverse events	NRL-1 10mg	20	54

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34022621	DERIVED	PubMed
34033266	DERIVED	PubMed
34418086	DERIVED	PubMed
35816831	DERIVED	PubMed
37455404	DERIVED	PubMed
38175488	DERIVED	PubMed
41809194	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02721069

GET https://conductscience.org/api/trials/v1/NCT02721069/events?page=2

API reference For AI assistants