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Intranasal Cooling for Symptomatic Relief of Migraine

NCT02375789 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-02-03

No results posted yet for this study

Summary

This study will be a randomised placebo controlled trial examining the effectiveness of using an intranasal cooling device (the RhinoChill) in providing relief of pain and symptoms of acute migraine. It will involve using two nasal catheters to cool the nasal cavity which provides localised cooling of the local nasal tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict as well as stimulating special cold receptors that are thought to be involved in the relief of migraine, thereby providing both pain and associated symptomatic relief. Ninety patients will be randomised in a 1:1 fashion, clustered to three different recruitment sites. The patients will have a 30 day period of data collection for their current migraine frequency, treatment and response to medication (with a minimum of 2 migraine attacks recorded) before starting the treatment phase with the RhinoChill Device. Treatment will be for 2 migraine attacks. Only a single treatment is allowed for the first attack, but on the second attack the patient may deliver 2 treatments with a gap of at least 2 hours between treatments.

Conditions

  • Migraine Headache

Interventions

DEVICE

Active RhinoChill

The device is intended for use for the reduction of temperature via the nasal cavity. The RhinoChill® System is a British Standards Institution Kite-Marked device that is currently commercially available in Europe. The RhinoChill® device is intended for temperature reduction in patients via the nasal cavity.

DEVICE

Placebo RhinoChill

The placebo RhinoChill device looks and functions in an identical way to the active RhinoChill. All components are used, however through some minor changes in the design of the device it now provides a sufficient placebo treatment to the patient.

Sponsors & Collaborators

  • BeneChill, Inc

    collaborator INDUSTRY

  • Cumbria Partnership NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Jitka Vanderpol, MD FRCP · Cumbria Partnership NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United Kingdom

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 NCT02375789 on ClinicalTrials.gov