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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Migraine Headaches

In brief

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.

Key facts

Study ID

NCT02057315

Run by

Achelios Therapeutics

People needed

48

Starts

2014-03-01

Expected to finish

2014-11-01

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Michigan Head Pain and Neurological Institute — Ann Arbor, Michigan, United States
• Coastal Carolina Research Center — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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