Prestige 2

You likely can't join if

• - Disease Target Exclusion Patient has a history of basilar migraine or hemiplegic migraine
• Medical History and Concurrent Diseases o Patient history of HIV disease o Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening. o Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled) o Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator’s opinion, might interfere with study assessments o Patient has a history of gastric, or small intestinal surgery, or has a disease thatcauses malabsorption o The patient has a history or current evidence of any significant and/or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator’s opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial o History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening o Patients should be excluded if they have a positive drug screen for drugs of abuse that in the investigator’s judgment is medically significant, in that it would impact the safety of the patient or the interpretation of the study results.
• Allergies and Adverse Drug Reactions History of drug or other allergy which, in the opinion of the principal investigator, makes the subject unsuitable for participation in the study
• Sex and Reproductive Status o Females of child-bearing potential who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study period and for 56 days after the study. o Women who are pregnant or breastfeeding. Women with a positive pregnancy test on enrollment or prior to study drug administration
• ECG and Laboratory Test Findings o Estimated glomerular filtration rate (eGFR) ≤ 40 ml/min/1.73m2 o Corrected QT interval > 470 msec (QTc by method of Frederica), during theScreening/Baseline Phase o Left Bundle Branch block o Right Bundle Branch Block with a QRS duration ≥ 150 msec. o Intraventricular Conduction Defect with a QRS duration ≥ 150 msec. o Serum bilirubin (Total, Direct or Indirect) > 1,0 mg/dl o Neutrophil count ≤ 40 % o AST (SGOT) or ALT (SGPT) > 45 U/l