Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine

A Randomized, Double-Blind, Cross-Over, Placebo-Controlled Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine

This is a Phase 1/ Phase 2, 12-week, multi-center, randomized, double-blind, cross-over, placebo-controlled study to evaluate the efficacy and safety of ELS-M11 compared to placebo in 50 male and female subjects, aged 18 to 65 years that suffer recurring moderate-severe migraine headaches (2-8 per month).

This study is designed to describe the efficacy and safety of ELS-M11 as compared to placebo.

Achelios is developing ELS-M11 for topical application for the acute treatment of migraine events in patients with a history of migraine with or without aura.

To be eligible for the study, patients must have a one-year documented history of migraine headache (as defined by the International Headache Society IHS), with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit.

The total duration of the study is the completion of five migraine headaches per subject over a maximum 12 week period followed by a 3-14 day Follow-Up Period.

Inclusion Criteria:

• Provide written informed consent
• Males and females aged 18-65 who can read, write and understand English
• Subject has at least a one year documented history of migraine headache (defined by International headache Society IHS) migraine definitions, with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit
• Is stable on the current standard non-opioid rescue medication for at least 2 months prior to randomization
• Can distinguish migraine from tension headache (HA), with 24 hours of freedom from HA between migraine events
• Women of childbearing potential must be currently using or willing to use contraception (30 days prior to start of study medication and for 21 days after taking study medication)
• Women of non-childbearing potential include females regardless of age, with functioning ovaries and who have a current documented tubal ligation [Hatcher, 2004] bilateral oophorectomy or total hysterectomy, or post-menopausal females
• The subject is able and willing to perform the assessments and procedures as specified in this protocol, including the ability to learn and follow instructions for ePRO device

Exclusion Criteria:

• Migraineurs taking opioid-based rescue medications for any indication
• Subject has history of mild migraine events or migraines that usually resolve spontaneously in less than 2 hours
• Subject has menstrual migraines
• Positive Drug Test
• Subject has basilar or hemiplegic migraines
• Subject has more than 15 headache-days per month
• Subjects with a history of facial allodynia
• Subject has a history of vomiting during more than 30% of migraine episodes
• Self confinement to bed rest for more than 50% of migraine episodes
• Subject was greater than 50 years old at age of migraine onset
• Acute coronary syndrome (i.e., myocardial infarction and unstable angina), stroke or resuscitated cardiac arrest within the past 3 months
• Severe congestive heart failure
• Systolic blood pressure (sBP) >160 mmHg or diastolic blood pressure (dBP) >100 mmHg measured in the sitting position at Visit 1
• Current active renal disease
• Any history of pyelonephritis
• Evidence of active liver disease
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase >2 times the upper limit of the reference range (ULRR), or total bilirubin >1.5 times the ULRR at Visit 1
• Past history of acute pancreatitis with current triglycerides 4.56 mmol/L (400 mg/dL) at Visit 1
• History of malignancy within the past 3 years, other than non-melanoma skin cancer (i.e., basal or superficial squamous cell carcinoma) and treated cervical cancer in-situ
• Any planned major surgery to be performed during the study (e.g., coronary artery bypass surgery, abdominal aortic aneurysm repair, etc.)
• Current life-threatening condition
• Significant hypersensitivity to NSAIDs (e.g., difficulty swallowing or breathing, tachycardia, anaphylaxis, angioedema or skin reaction)
• Pregnancy (defined by positive urine pregnancy test) or lactation at Visit 1, or planning to become pregnant prior to completion of the study
• History or suspicion of alcohol or substance abuse (current or past 6 months).
• Participation in any clinical trial within 30 days prior to Visit 1
• Subjects with a history of hypersensitivity to products containing tiaprofenic acid, suprofen, fenofibrate, oxybenzone, or octocrylene (e.g., sunscreen, perfume)
• Subjects with a history of photosensitivity
• Any clinically significant abnormality or any reason that the subject may not be able to complete the full study observational period