| Eligibility |
Inclusion Criteria:
- Men and women aged =18 years who have previously been diagnosed with migraine, with or
without aura, in accordance with the ICHD-3 Classification criteria;
- Have an estimated frequency of 5 to 14 MDM in each of the 3 months prior to enrolment;
- In principle, agree at the beginning (virtual call V0) to adequately complete a
headache electronic diary (e-Diary) on at least 24 days out of the 28 days in the
run-in baseline period;
- In practice, adequately complete by the end of V1 a headache eDiary on at least 24
days out of the 28 days in the run-in baseline period;
- Agree to refrain from initiating or changing the type, dosage, or frequency of any
prophylactic medications against migraine, and any treatments for indications other
than migraine that in the opinion of the clinician may interfere with the study
objectives, e.g. antidepressants, anticonvulsants, beta-blockers, etc. for the
duration of the study;
- Women of childbearing potential must agree to use a medically effective form of
contraception, unless they can confirm they've had bilateral tubal ligation or that
their male partner has had a vasectomy (provided that the partner is the sole sexual
partner of the trial participant and that the vasectomised partner has received
medical assessment of the surgical success). Medically effective forms of
contraception include hormonal methods, such as the contraceptive pill or implant
(stable use for at least 3 months prior to enrolment), an intrauterine device (IUD) in
use at least 30 days before enrolment, or barrier methods such as diaphragm plus
spermicide or condom plus spermicide, in use at least 14 days before enrolment. In
circumstances in which hormonal methods may interfere with the action of the IP or
placebo, or in which the use of spermicides may increase the risk of transmission of
disease, a double-barrier method is recommended.
- Agree to refrain from making any drastic changes to their usual diet for the duration
of the study, particularly periods of fasting;
- Have a smartphone with Android or mobile operating system version compatible with
eDiary;
- Able to provide informed consent
Exclusion Criteria:
Under ketogenic diet, or using exogenous ketone supplements, e.g. medium chain
triglycerides (MCT) 1 month prior to the initiation of the study or during the study;
- Patients using regular high dose of Vitamin B3, calcium (>1 g/day) or magnesium (>350
mg/day) supplements 1 month prior to the initiation of the study or during the study;
- Suffer from other primary (e.g. tension-type headache, trigeminal autonomic
cephalalgias, other primary headache disorders) or secondary headaches (e.g. headaches
attributed to trauma or injury, vascular or non-vascular intracranial disorders,
substances or their withdrawal, infections, alterations of homeostasis), hemiplegic
migraine;
- Pregnancy or intending to become pregnant, or is of childbearing potential and has not
had tubal ligation, has a male partner who has not had a successful vasectomy, and is
unwilling to use a medically effective form of contraception, i.e. oral contraceptive
pills, injectable, or implantable contraceptive; intrauterine device; or
double-barrier method (e.g. diaphragm and condom), or is lactating during the study
duration. In addition, women of child-bearing potential on hormone-based contraception
should not intend to stop or change their contraceptive for the duration of the study;
- Significant medical history, for example diabetes mellitus, renal stones, kidney and
liver failure, somatic or psychiatric conditions, uncontrolled hypertension or
medicated for hypertension, known hypercalcemia, history of or current cardiovascular
disease, chronic gastrointestinal (GI) disease or intestinal malabsorption, or other
illness, disease or syndrome which the investigators deem unsuitable to participate in
the study;
- Significant medication history, for example use of corticosteroids in format of oral
or injectable;
- Vaccination planned 2 weeks prior the start of the study, or during the study;
- Patients following a sodium-restricted diet;
- History of chronic alcohol or substance misuse;
- Previously diagnosed food allergy;
- Is participating in another clinical trial or has participated in a clinical trial the
preceding month.
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