Migraine Headaches
Conditions
Keywords
Migraine headache, Photophobia, Phonophobia, Aura, Topical treatment
Brief summary
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.
Detailed description
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.
Interventions
DRUGELS-M11
One dose of 5% ELS-M11 over 3 bilateral applications.
DRUGPlacebo
One dose of matching placebo over 3 bilateral applications.
Sponsors
Achelios Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who experience pain relief 2 hours following the first application of ELS-M11 | 2 hours | Pain relief (as defined by a one point decrease on a 4 point pain intensity scale) in subjects experiencing a moderate to severe migraine headache, 2 hours after the initial application of ELS-M11. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who report complete pain resolution within 24 hours following the first application of ELS-M11. | 24 hours | Complete resolution (intensity score of 0 on a 0-3 pain scale) of migraine pain within 24 hours, following ELS-M11 application in subjects experiencing a moderate to severe migraine headache. |
| Percentage of patients who report sustained pain relief after the first application of ELS-M11 | 24 hours | Sustained pain relief defined as pain relief by 2 hours post study medication application with no increase in the pain intensity score up to 24 hours post medication application in moderate and severe headaches, following ELS-M11 application. |
| Percentage of patients who report sustained complete pain resolution after the first application of ELS-M11. | 24 hours | Sustained complete pain resolution defined as pain free by 2 hours post study medication application with no change in a pain intensity score of 0 up to 24 hours post medication application in moderate and severe headaches, following ELS-M11 application. |
| Percentage of patients who report pain relief at various time points within a 24 hour period, following the first application of ELS-M11 | 24 hours | Pain relief (as defined by a one point decrease on a 0-3 point pain intensity scale) in subjects experiencing a moderate to severe migraine headache over a 24 hour period following the first application of ELS-M11. |
| Use of Rescue Medication following the first application of ELS-M11 by 24 hours | 24 hours | Use of Rescue Medication within 24 hours following ELS-M11 application in patients experiencing moderate to severe migraine headaches. |
| Resolution of migraine-associated symptoms, following the first application of ELS-M11 | 24 hours | Free of migraine-associated symptoms within 24 hours after ELS-M11 application in patients experiencing moderate to severe migraine headaches. |
| Percentage of patients who can resume or maintain their normal routine, following the first application of ELS-M11. | 24 hours | Resuming or maintaining normal routine within 24 hours after first study medication application in moderate and severe headaches. |
| Time to Initial Use of Rescue Medication following the first application of ELS-M11 | 24 hours | Time to Initial Use of Rescue Medication following ELS-M11 application in subjects experiencing moderate to severe headaches within a 24 hour period |
Countries
United States
Outcome results
None listed