Receives the investigational medicine product (IMP; Beta-hydroxybutyrate calcium and magnesium salt).

Receives a matched placebo powder to the IMP.

Migraine

Episodic Migraine

Exogenous ketone body in mineral salt form.

Beta-hydroxybutyrate calcium and magnesium salt

placebo powder

University Children's Hospital (UKBB)

Energy for the Brain

Safety, Tolerability and Efficacy of Exogenous Ketone Bodies for Preventive Treatment of Migraine: A Randomised, Placebo-controlled, Double-blind Study

Mean change from baseline in number of migraine days (meeting International Classification of Headache Disorders (ICHD)-3 criteria) during the last month of intervention in treatment group compared to placebo.

Mean change from baseline in number of headache days of any severity (meeting ICHD-3 criteria) during the last month of intervention in treatment group compared to placebo.

Mean change from baseline in consumption of acute migraine medication (analgesics or triptans) measured in days with acute headache medication use during the last month of the intervention.

Mean change from baseline in migraine intensity (measured with a numerical rating scale from 1-10) during the last of month of the intervention period.

Score in Migraine Disability Assessment (MIDAS; end of baseline versus end of intervention).

Score in Headache Impact Test (HIT-6; end of baseline versus end of intervention).

Serum concentration changes from baseline of oxidative and nitrosative stress markers (malondialdehyde (MDA), carbonylated proteins, nitrate, nitrite, nitrotyrosine), levels in cytokines, levels in lactate, glucose, insulin and markers of thyroid function. Genetic profile (SNPs) of all patients involved in the study and correlation of the genetic markers with 1-5 using a linear regression model. Gene expression changes before and after diet using expression microarrays with a special focus on mitochondrial related genes (Citrate synthesis, Cytochrom C oxidase subunit 1, Succinate dehydrogenase subunit A). Correlation of gene expression changes with the genetic profile of the patients (eQTL analysis in combination with 1-5 as possible covariates.

University Hospital, Basel, Switzerland

Intervention: Twice-daily administration of N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablets

Intervention: Twice daily administration of sham/placebo tablet

Migraine, Headaches

N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet

Effect on Migraine Frequency of Combined Anti-oxidant Therapy: The MIGRANT Study.

Effect on Migraine Frequency of Combined Anti-oxidant Therapy: N-acetylcysteine, Vitamin E and Vitamin C (NEC): The MIGRANT Study

Difference in mean number of migraine episodes per month between baseline and final four weeks of the study, for both study groups.

Difference in mean migraine duration (hours) per month between baseline and final four weeks of the study, for both study groups

Difference in mean migraine severity score per month (categorical scale; 0 = nil, 1 = mild, 2 = moderate, 3 = severe) between baseline and final four weeks of the study, for both study groups.

Migraine Disability Assessment Score (MIDAS).

Difference in mean MSQ score per month between baseline and final four weeks of the study, for both study groups. Migraine Specific Quality of Life Questionnaire (MSQ, Version 2.1) score.

Difference in mean HRQOL score per month between baseline and final four weeks of the study, for both study groups.Health Related Quality of Life (HRQOL) score

Number of treatment adverse events per month

Difference in mean number of migraine days per month between baseline and final four weeks of the study, for both study groups.

Responder rate: Percentage of subjects reporting ≥ 30% reduction in migraine episodes per month between baseline and final four weeks of the study, for both study groups

Professor Eric Visser

Professor Eric J Visser

University of Notre Dame Australia

Dexamethasone 10 mg
Dexamethasone: Dexamethasone 10mg IV

Dexamethasone

Placebo Dexamethasone, 10 mg
Placebo: Placebo Dexamethasone 10mg IV

Placebo

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

Duration of headache Prior to Study

Achieve headache freedom within two hours in the emergency department and no recurrence of pain within 24 hours of emergency department discharge

Persistent Headache Pain Free at 24 Hours

No functional impairment within 24 hours of emergency department discharge

antimigraine/inflamação

Energy for the Brain

Effect on Migraine Frequency of Combined Anti-oxidant Therapy: The MIGRANT Study.

Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines

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