PAREMA1

• Research type

  Research Study

• Full title

  A prospective, multi-centre, randomized, single-blind, sham-controlled, parallel-group, group-sequential study to investigate safety and efficacy of the Rehaler partial rebreathing device, in adults suffering from migraine with aura

• IRAS ID

  318256

• Contact name

  Shazia Afridi

• Contact email

  Shazia.Afridi@gstt.nhs.uk

• Sponsor organisation

  Rehaler A/S

• Clinicaltrials.gov Identifier

  NCT05546385

• Duration of Study in the UK

  2 years, 1 months, 1 days

• Research summary

  Migraine affects 14.7% of the world´s population and is the most common neurological disease, characterized by recurrent debilitating attacks that can last from a few hours to several days. Migraine with aura (MA) is a subset of migraine, comprising about a third of migraine patients. MA attacks often start with or are accompanied by so-called aura symptoms: visual disturbances, somatosensory disturbances, and/or speech-related problems.

  Current acute treatments for MA are only moderately effective and often poorly tolerated, causing significant side effects, and restricting the use in sub-groups of migraine. In a survey of more than 15.000 migraine patients in the US, 74% reported that they were not fully satisfied with their current acute treatment. In general, there is a need for new, effective and affordable non-pharmaceutical migraine treatments.
  The sponsor of the planned study (Rehaler A/S) has developed a medical device for treatment of migraine-with-aura attacks. It is a single-use medical device for home use by patients aged 18+.

  The device works by partial rebreathing, meaning that part of the expired air is captured and subsequently rebreathed together with a controlled amount of atmospheric air. This leads to an increase in CO2 in the blood combined with a normal arterial oxygen saturation. Previous studies have shown that by increasing the CO2 level and oxygen/energy supply to the brain, a large percentage of migraine attacks can be stopped or alleviated.
  The device has previously been tested on patients as part of a pilot study with similar design. The purpose of the proposed clinical pivotal study is to collect safety and performance data using the current design of the Rehaler device in patients undergoing migraine attacks with aura.
  

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  22/WM/0259

• Date of REC Opinion

  4 Jan 2023

• REC opinion

  Further Information Favourable Opinion