22 November 2021 | Monday | News
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This fully virtual study has been approved for conduct in the Canadian province of Quebec, with scientific and regulatory support from the Food & Nutrition Group within Intertek Assuris and is powered by a dedicated module within the Migraine Buddy app developed by Healint. The Clinical Research Unit at Nestlé Research is managing the trial and the clinical operations activities are being executed by DIEX Recherche. This represents for Nestlé the first randomized clinical trial for central nervous system conditions to be conducted fully remotely, with no visits at the clinical site. 1
The digital platform allows participants in the province of Quebec to be screened, recruited, and tracked in real-time across the five-month study, all from a single, easy-to-use, virtual interface. Moreover, the digital aspect reduces the risk of human errors associated with traditional paper-based records and increases the speed of data capture and cleaning.
"Migraines can be seriously incapacitating for sufferers, affecting every aspect of their lives," said Stephanie Blum, Global Head of Translation Research for Nestlé Health Science. "We have seen promising evidence that by improving brain energy metabolism, for example with the use of ketones, the impact of migraines can be lessened." Nestlé Health Science is using a fully virtual study to improve patient experience, making trial participation more accessible and convenient, paving the way to future end-to-end digital clinical studies in medical nutrition.
"The COVID-19 pandemic has highlighted the need and benefit for clinical trials to go fully virtual; there are multiple cost efficiencies and benefits to a fully remote clinical trial which technology platforms like Migraine Buddy can facilitate," said François Cadiou, CEO of Healint.
"We firmly believe that mobile health has the potential to revolutionize the way clinical studies are delivered" said Cadiou. "We are delighted that this partnership with Nestlé Health Science will allow clinical trials to proceed remotely and promote inclusion by extending the range of participants to beyond those residing near physical trial sites."
Migraine is the sixth most disabling illness in the world, which affects around a billion people worldwide. More than half of all migraine sufferers are never diagnosed, while 15% of those diagnosed with migraine experience more than five attacks per month. Considering that 75% of the migraine population is female and that prevalence peaks between the ages for 18 and 44, the burden of migraine falls most heavily on women of childbearing age. Migraine is characterized by moderate to severe headache and is often accompanied by nausea, vomiting and photophobia.2 It has detrimental effects on daily activities, it reduces quality of life and impairs productivity with limited participation in professional, academic, and social settings.