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

NCT ID: NCT02057315

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-11-30

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.

Conditions

Migraine Headaches

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ELS-M11

Topical 5% ELS-M11 (3 g)

Group Type: EXPERIMENTAL

ELS-M11

Intervention Type: DRUG

One dose of 5% ELS-M11 over 3 bilateral applications.

Placebo

Intervention Type: DRUG

One dose of matching placebo over 3 bilateral applications.

Placebo

A matching formulation with no active ingredient

Group Type: PLACEBO_COMPARATOR

ELS-M11

Intervention Type: DRUG

One dose of 5% ELS-M11 over 3 bilateral applications.

Placebo

Intervention Type: DRUG

One dose of matching placebo over 3 bilateral applications.

Interventions

ELS-M11

One dose of 5% ELS-M11 over 3 bilateral applications.

Intervention Type: DRUG

Placebo

One dose of matching placebo over 3 bilateral applications.

Intervention Type: DRUG

Other Intervention Names

Topofen (ketoprofen) Gel 5%

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Achelios Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Crist J. Frangakis, Ph.D.

Role: STUDY_CHAIR

Achelios Therapeutics, Inc.

Locations

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States

Coastal Carolina Research Center

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

ACH10200

Identifier Type: -

Identifier Source: org_study_id