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Migraine HeadachesPhase 1/2NCT02057315

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

A Phase 1/2 study testing ELS-M11 in people with Migraine Headaches, run by Achelios Therapeutics at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Headaches
What is being tested?
ELS-M11
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
2 sitesUnited States
Study dates
Mar 2014to Nov 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan, 48104

  • Coastal Carolina Research Center

    Charleston, South Carolina, 29464

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
ELS-M11, Placebo
Keywords
Migraine headache, Photophobia, Phonophobia, Aura, Topical treatment
Medical subject headings
Migraine Disorders, Photophobia, Hyperacusis, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELS-M11Drug

    Also called Topofen (ketoprofen) Gel 5%

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

  • PlaceboDrug

    One dose of matching placebo over 3 bilateral applications.

Study groups in NCT02057315
Study groupRoleWhat they receive
ELS-M11ExperimentalTopical 5% ELS-M11 (3 g)
Receives: Drug: ELS-M11; Drug: Placebo
PlaceboPlacebo comparatorA matching formulation with no active ingredient
Receives: Drug: ELS-M11; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 hours

Secondary outcomes (8)

  1. Percentage of patients who report pain relief at various time points within a 24 hour period, following the first application of ELS-M11

    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.

    Measured: 24 hours

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

    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.

    Measured: 24 hours

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

    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.

    Measured: 24 hours

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

    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.

    Measured: 24 hours

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

    Time to Initial Use of Rescue Medication following ELS-M11 application in subjects experiencing moderate to severe headaches within a 24 hour period

    Measured: 24 hours

  6. Use of Rescue Medication following the first application of ELS-M11 by 24 hours

    Use of Rescue Medication within 24 hours following ELS-M11 application in patients experiencing moderate to severe migraine headaches.

    Measured: 24 hours

  7. Resolution of migraine-associated symptoms, following the first application of ELS-M11

    Free of migraine-associated symptoms within 24 hours after ELS-M11 application in patients experiencing moderate to severe migraine headaches.

    Measured: 24 hours

  8. Percentage of patients who can resume or maintain their normal routine, following the first application of ELS-M11.

    Resuming or maintaining normal routine within 24 hours after first study medication application in moderate and severe headaches.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057315
Sponsor's protocol ID
ACH10200
Status last verified
Jul 2017
First submitted
5 Feb 2014
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ELS-M11 in people with Migraine Headaches, run by Achelios Therapeutics at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients who experience pain relief 2 hours following the first application of ELS-M11 (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02057315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.

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