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

NCT02057315 | Completed Phase 1

• 1 other identifier: ACH10200
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Migraine Headaches

Keywords

Migraine headache; Photophobia; Phonophobia; Aura; Topical treatment

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who experience pain relief 2 hours following the first application of ELS-M11

  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.

  2 hours

Secondary Outcomes (8)

• 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

• Percentage of patients who report complete pain resolution within 24 hours following the first application of ELS-M11.

  24 hours

• Percentage of patients who report sustained pain relief after the first application of ELS-M11

  24 hours

• Percentage of patients who report sustained complete pain resolution after the first application of ELS-M11.

  24 hours

• Time to Initial Use of Rescue Medication following the first application of ELS-M11

  24 hours

Study Arms (2)

ELS-M11

EXPERIMENTAL

Topical 5% ELS-M11 (3 g)

Drug: ELS-M11; Drug: Placebo

Placebo

PLACEBO COMPARATOR

A matching formulation with no active ingredient

Drug: ELS-M11; Drug: Placebo

Interventions

ELS-M11 DRUG

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

Also known as: Topofen (ketoprofen) Gel 5%

ELS-M11; Placebo

Placebo DRUG

One dose of matching placebo over 3 bilateral applications.

ELS-M11; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Achelios Therapeutics: lead

Study Sites (2)

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Coastal Carolina Research Center

Charleston, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Photophobia; Hyperacusis; Epilepsy

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Crist J. Frangakis, Ph.D.

  Achelios Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 7, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

US (2)