MLD10 in the Prevention of Migraine in Adults

Inclusion Criteria

• male or female, in otherwise good health, 18 to 65 years of age.
• history of frequent episodic migraine (3-14 migraine days per month) (with or without aura) according to the International Classification of Headache Disorders-3beta for at least 3 months.
• onset of migraine before age 50.
• stable history of migraine at least 3 months prior to screening.
• not currently taking a migraine preventive or has been taking preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period.
• if female of childbearing potential, has a negative urine pregnancy test at Visits 1-5 and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as listed:
• complete abstinence from intercourse from 2 weeks prior to administration of study drug, throughout the study, and for 7 days after completion or premature discontinuation from the study; surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); sterilization of male partner when in a monogamous relationship; intrauterine device with published data showing lowest expected failure rate is less than 1% per year; double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.
• completion of online diary must be ≥ 80% compliance, unless otherwise approved by the Sponsor and/or Clinvest.

Exclusion Criteria

• unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.
• pregnant, actively trying to become pregnant, or breast-feeding.
• diagnosed with International Classification of Headache Disorders-3beta criteria for Chronic Migraine within 3 months prior to screening, at the time of screening, and/or during the baseline period.
• experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine within the last year.
• history of medication overuse headache (MOH) (Appendix II) in the 3 months prior to study enrollment or during the baseline phase.
• history of medication overuse (MO) of ergotamines, triptans, opioids, analgesics, NSAIDS and combination therapies, as defined by ICHD-3beta criteria and/or MO during baseline period.
• history of substance abuse and/or dependence, in the opinion of the Investigator.
• history of impaired renal function that, in the investigator's opinion, contraindicates participation in this study.
• unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure.
• suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events.
• has significant risk of suicide, defined as a "yes" answer to any of the following questions on the Columbia-Suicide Severity Rating Scale (C-SSRS), either at the screening visit (when assessing the prior 12 months) or at visit 2 (when assessing time since the screening visit):
• Questions 4 or 5 on the suicidal ideation section
• Any question on any item in the suicidal behavior section
• any psychiatric disorder with psychotic features, and/or any other psychiatric disorder not stable or well controlled, that would interfere in their ability to complete study activities.
• hypersensitivity, intolerance, or contraindication to the use of magnesium L-lactate dehydrate or any of its components.
• received any investigational agents within 30 days prior to Visit 1.
• plans to participate in another clinical study at any time during this study.