NCT04089761

Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents

Terminated NA Results posted Last updated 25 February 2021

What this trial tests

NA trial testing Nerivio in Acute Migraine in 60 participants. Terminated before completion.

Timeline

1 October 2019

Primary endpoint
10 May 2020

24 May 2020

Quick facts

Lead sponsor	Theranica
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 October 2019
Primary completion	10 May 2020
Estimated completion	24 May 2020
Sites	12 locations across United States

Drugs / interventions tested

• Nerivio

Conditions studied

• Acute Migraine — all drugs for Acute Migraine →

Sponsor

Theranica — full company profile →

Who can join

Adults 12 to 17, any sex, with Acute Migraine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety of Nerivio Device Primary · 12 weeks

Number of Participants with Device-Related Adverse Events

Group	Value	95% CI
Active Device	1

Pain Relief at 2 Hours Post Treatment Secondary · 2 hours post treatment

The percentage of subjects reporting, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain. Pain level was reported using a 4-point Likert scale (0 -No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)

Group	Value	95% CI
Active Device	28

Pain-free at 2 Hours Post Treatment Secondary · 2 hours post treatment

The percentage of subjects reporting, for the test treatment, no pain at 2 hours post-treatment without the use of rescue medication. Pain-free is defined as improvement from mild, moderate, or severe pain to no pain. Pain level was reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)

Group	Value	95% CI
Active Device	14

Disappearance of Nausea at 2 Hours Post-treatment Secondary · 2 hours post treatment

The percentage of subjects presented nausea at the baseline (T=0 hours) and reported disappearance of nausea at 2 hours post-treatment of the test treatment

Group	Value	95% CI
Active Device	12

Disappearance of Photophobia at 2 Hours Post Treatment Secondary · 2 hors post treatment

The percentage of subjects presented photophobia at baseline (T=0 hours) and reported disappearance of photophobia at 2 hours post-treatment of the test treatment

Group	Value	95% CI
Active Device	13

Disappearance of Phonophobia at 2 Hours Post Treatment Secondary · 2 hours post treatment

The percentage of subjects presented phonophobia at baseline (T=0 hours) and reported disappearance of phonophobia at 2 hours post-treatment of the test treatment

Group	Value	95% CI
Active Device	10

Sustained Pain Relief at 24 Hours Post Treatment Secondary · 24 hours post treatment

The percentage of subjects achieving, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication and no relapse of headache pain within 24 hours

Group	Value	95% CI
Active Device	20

Sustained Pain Free at 24 Hours Post Treatment Secondary · 24 hours post treatment

The percentage of subjects achieving, for the test treatment, freedom from pain at 2 hours post-treatment without the use of rescue medication and no relapse of headache pain within 24 hours

Group	Value	95% CI
Active Device	10

Functional Disability at 2 Hours Post Treatment Secondary · 2 hours post treatment

The percentage of subjects achieving improvement of at least one grade in functional disability in the test treatment at 2 hours post-treatment with no use of rescue medication

Group	Value	95% CI
Active Device	23

Functional Disability at 24 Hours Post Treatment Secondary · 24 hours post treatment

The percentage of subjects achieving improvement of at least one grade in functional disability in the test treatment at 24 hours post-treatment with no use of rescue medication

Group	Value	95% CI
Active Device	20

Within-subject Consistency of the Pain Relief Response Secondary · 8 weeks

parcentage of subjects achieving pain relief at 2 hours in at least 50% of all their treatments

Group	Value	95% CI
Active Device	26

Within-subject Consistency of the Freedom From Pain Response Secondary · 8 weeks

percentage of subjects achieving freedom from pain at 2 hours in at least 50% of all their treatments

Group	Value	95% CI
Active Device	13

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Device

Serious: 0/45 (0%)

Deaths: 0/45

Other adverse events (8 terms — click to expand)

Reaction	System	Active Device
chest congestion	Respiratory, thoracic and mediastinal disorders	—
Influenza	Respiratory, thoracic and mediastinal disorders	—
Pain in the arm	Nervous system disorders	—
Common Cold	Reproductive system and breast disorders	—
Leg pain	General disorders	—
streptococcus pharyngitis	Infections and infestations	—
Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	—
Worsen migraine	Nervous system disorders	—

Data from ClinicalTrials.gov NCT04089761 adverse events section.

Sponsor's own description

Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism.

This is a prospective, single arm, open label, multicenter trial of the safety and efficacy of Nerivio™ for the acute treatment of migraine in adolescents

The study will be conducted in three phases:

Phase I - Run-in:

Phase II - Treatment phase:

Phase III (optional) - Free-use

Publications & conference data

No peer-reviewed publications indexed yet for this trial.