L-arginine and aged garlic extract for the prevention of migraine: a study protocol for a randomised, double-blind, placebo-controlled, phase-II trial (LARGE trial)

Devahuti R Chaliha; Mauro Vaccarezza; Emily Corti; Ryusuke Takechi; Satvinder S Dhaliwal; Peter Drummond; Eric Visser; Fred K Chen; Jason Charng; Virginie Lam; John C L Mamo

doi:10.1186/s12883-023-03149-y

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L-arginine and aged garlic extract for the prevention of migraine: a study protocol for a randomised, double-blind, placebo-controlled, phase-II trial (LARGE trial)

Journal article

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L-arginine and aged garlic extract for the prevention of migraine: a study protocol for a randomised, double-blind, placebo-controlled, phase-II trial (LARGE trial)

Devahuti R Chaliha, Mauro Vaccarezza, Emily Corti, Ryusuke Takechi, Satvinder S Dhaliwal, Peter Drummond, Eric Visser, Fred K Chen, Jason Charng, Virginie Lam, …

BMC neurology, Vol.23(1), Art. 122

2023

DOI: https://doi.org/10.1186/s12883-023-03149-y

PMID: 36973718

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Abstract

Australia - epidemiology

Clinical Trials, Phase II as Topic

Double-Blind Method

Garlic

Headache

Migraine Disorders - diagnosis

Migraine Disorders - drug therapy

Migraine Disorders - prevention & control

Randomized Controlled Trials as Topic

Treatment Outcome

Background Migraine is a common and distressing neurological condition characterised by recurrent throbbing headaches, nausea and heightened sensitivity to light and sound. Accumulating evidence suggests that cerebral arteries dilate during migraine, causing distal microvessels to constrict, which could activate nociceptors and cause onset of headache pain. If so, preventing or attenuating chronic microvascular constriction, and promoting a dilatory phenotype, may reduce frequency and/or severity of migraines. The primary aim of the L-Arginine and Aged Garlic Extract (LARGE) trial is to investigate whether oral treatment with dietary nutraceuticals, L-arginine and aged garlic extract (AGE), both systemic vasodilatory agents, will alleviate migraine frequency, duration and severity in adults with chronic frequent episodic migraines. Methods The study is a randomised double-blind placebo-controlled phase-II single-site clinical trial conducted in Perth, Australia. The target sample is to recruit 240 participants diagnosed with chronic frequent episodic migraines between 18 and 80 years of age. Participants will be randomised to one of four treatment groups for 14 weeks (placebo induction for 2 weeks, followed by 12 weeks on one of the respective treatment arms): placebo, L-arginine, AGE, or a combination of L-arginine and AGE. The doses of L-arginine and AGE are 1.5 g and 1 g daily, respectively. The primary outcome is to assess migraine response using change in migraine frequency and intensity between baseline and 12 weeks. Secondary outcomes include the impact of L-arginine and/or AGE on photosensitivity, retinal vessel changes, and blood biomarker concentrations of vascular tone, following a 12-week intervention. Discussion The protocol describes the oral administration of 2 nutraceutical-based interventions as possible prophylactic treatments for chronic frequent episodic migraines, with potential for direct clinical translation of outcomes. Potential limitations of the study include the fixed-dose design of each treatment arm and that in vivo neuroimaging methods, such as magnetic resonance imaging (MRI), will not be conducted to determine putative cerebro-vasodilatory changes to coincide with the outcome measures. Dose-response studies may be indicated. Trial registration The trial was retrospectively registered with the Australian New Zealand Clinical Trials Registry ACTRN12621001476820 (Universal Trial Number: U1111-1268-1117) on 04/08/2021. This is protocol version 1, submitted on 25/11/2022.

Details

Title: L-arginine and aged garlic extract for the prevention of migraine: a study protocol for a randomised, double-blind, placebo-controlled, phase-II trial (LARGE trial)
Authors/Creators: Devahuti R Chaliha - Curtin University
Mauro Vaccarezza - Curtin University
Emily Corti - Curtin University
Ryusuke Takechi - Curtin University
Satvinder S Dhaliwal - Singapore University of Social Sciences
Peter Drummond - Murdoch University, Centre for Healthy Ageing
Eric Visser - University of Notre Dame
Fred K Chen - Ophthalmology, Department of Surgery, The University of Melbourne, East Melbourne, VIC, Melbourne, Australia
Jason Charng - Department of Optometry, School of Allied Health, The University of Western Australia, Perth, WA, Australia
Virginie Lam - Curtin University
John C L Mamo - Curtin University
Publication Details: BMC neurology, Vol.23(1), Art. 122
Publisher: BioMed Central Ltd as Part of Springer Nature.
Identifiers: 991005567367407891
Murdoch Affiliation: Centre for Healthy Ageing
Language: English
Resource Type: Journal article

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Collaboration types: Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.247 Migraines & Headaches; 1.247.461 Migraine Mechanisms
Web Of Science research areas: Clinical Neurology
ESI research areas: Neuroscience & Behavior