Intranasal Cooling for Symptomatic Relief of Migraine

NCT02375789 | Terminated DMC

• 1 other identifier: 3414
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Migraine Headache; Cooling; Intranasal; Rhinochill

Outcome Measures

Primary Outcomes (1)

• Pain free at two hours following treatment

  Percentage of patients who are pain free two hours following treatment

  Two hours following treatment

Secondary Outcomes (18)

• Percentage of patients pain free

  10 mins, 1 hour, 2 hours, 24 hours

• Headache response

  10 mins, 1 hour, 24 hours

• Pain response

  10 mins, 1 hour, 2 hours, 24 hours

• Relapse Incidence

  Between 2 and 48 hours after the intervention

• Sustained Pain Freedom

  Between 1 and 24 hours after the intervention

Study Arms (2)

Active RhinoChill

ACTIVE COMPARATOR

Following the initial 30 days (and minimum of 2 separate migraine attacks) of data collection the patient will be trained in the use and self administration of the RhinoChill device. At the onset of an acute migraine, the patient will insert the RhinoChill Migraine Intranasal catheters and commence a 10 minute treatment on the Low Flow setting of the device. During this time the patient will complete the basic data record sheets to document current symptoms and changes in severity throughout the period of treatment and then at specific time points thereafter. The patient remains in the trial until two separate migraines have been treated.

Device: Active RhinoChill

Placebo RhinoChill

PLACEBO COMPARATOR

The same procedure will be followed for the placebo comparator as in the active comparator. The RhinoChill device looks identical and functions in a very similar way to the active device however through some minor design changes the device has been altered to provide a sufficient placebo treatment. At the onset of an acute migraine headache the patient will insert the RhinoChill Migraine Intranasal catheters and the 10 minute treatment is commenced on Low Flow. During this time the patient will complete the basic data record sheets to document current symptoms and changes in severity throughout the period of treatment and then at specific time points thereafter. The patient remains in the trial until two separate migraines have been treated.

Device: Placebo RhinoChill

Interventions

Active RhinoChill DEVICE

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.

Also known as: RhinoChill

Active RhinoChill

Placebo RhinoChill DEVICE

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.

Also known as: RhinoChill

Placebo RhinoChill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years or over and ≤70 years of age.
• Migraine diagnosis of at least 1 year.
• Migraine attacks between 1 and 15 per month.
• Onset of first migraine \< 50 years of age.
• Migraine prophylaxis medication unchanged for 3 months prior to enrollment
• Meets International Classification for Headache Disorders (2nd Edition) criteria for diagnosis of Episodic Migraine with or without aura
• Able to attend and understand a short training session on the practical use of the RhinoChill device and agrees to only use the device as instructed and as laid out in the official instructions for use.

You may not qualify if:

• \< 18 and \>70 years of age
• Known oxygen dependency to maintain SaO2 \>95%
• Diagnosed Hypertensive and currently uncontrolled with Systolic BP \> 140mmHg and Diastolic BP \> 90mmHg on baseline assessment.
• Marked nasal septal deviation, recurrent epistaxis or chronic Rhino-Sinusitis
• Intranasal obstruction preventing full insertion of nasal catheter
• Known acute base of skull fracture or facial trauma
• Concurrent sinus/intranasal surgery
• Diagnosed with thromobocytopenia.
• Previous Stroke or Myocardial Infarction
• Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity
• Previously enrolled into the COOLHEAD 1 trial
• No recorded migraine following initial 30 day data collection period

Sponsors & Collaborators

• Cumbria Partnership NHS Foundation Trust: lead
• BeneChill, Inc: collaborator

Study Sites (3)

Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust

Penrith, Cumbria, CA11 8HX, United Kingdom

Location

CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST, 11 Norfolk Street, Sunderland SR1 1EA

Sunderland, Tyne and Wear, SR4 7TP, United Kingdom

Location

The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

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MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jitka Vanderpol, MD FRCP

  Cumbria Partnership NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: March 3, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

GB (3)