Migraine HOPE Trial

Efficacy of Apoaequorin for Improving Quality of Life (QOL) Symptoms for Pain and Frequency of Migraine Headache sufferers.

This Study is pre-enrolling.  Interested individuals can enter contact information and a representative will contact them in the next 30-60 days.

Purpose

The purpose of this study is to determine if apoaequorin may improve the QOL scores in adults with recurring migraine headaches.  Apoaequorin works by buffering excessive calcium in brain nerve cells and may reduce pain and frequency of headaches.

Primary Outcome Measures

  • Change in weekly pain scores over a 12 week period, as well as show a change in quality of life scores.
  • Number of days with migraine per month.
Estimated Enrollment: 100
Study Enrollment Start Date: July
Estimated Study Completion Date: Winter 2012

Rationale

Nearly one in four U.S. households have someone who suffers from migraine headaches, totalying more than 30 million people.

Intracellular calcium dysregulation has been cited as an important mechanism as a source of migraine headaches.  Experts have identified abnormally functioning calcium channels, which transport electrical calcium into the brain cell, as a reason for excessively high levels of calcium and subsequent overstimulation as a key contributor to migraine headaches.

Apoaequorin is a safe non-toxic dietary supplement which has been available for over 3.5 years. In laboratory experiments conducted at the University of Wisconsin-Milwaukee, apoaequorin proved highly neuroprotective. Apoaequorin is a naturally-occurring calcium-binding protein, which is very similar to endogenous proteins which have been shown to deplete with age. In human trials of generally healthy adults, apoaequorin has shown to help cognition.

By binding excess calcium, apoaequorin has been shown in some individuals to improve the Quality of Life through reduction of pain, greater mobility, increased energy, better sleep and additional quality of life measures.

Eligibility

Ages Eligible for Study: 18 years to 55 years old
Genders Eligible for Study: Male or Female
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

  • At least three consecutive days of migraines per month for at least three months
  • Is currently not taking a preventive migraine medication or has been taking a preventive for at least 30 days prior to screening
  • Agrees to not start, stop, or change medication and/or dosage during the study period.
  • Lives in the United States

Exclusion Criteria:

  • Uncontrolled or untreated psychiatric condition
  • Is pregnant, actively trying to become pregnant, or is breast-feeding
  • Unable to connect to internet from home
  • Any condition which confounds the ability to interpret data from the study
  • Participating, plans to participate or does participate in another clinical study at any time during this study is terms for automatic disqualification

Locations

Throughout the United States. This study is considered a distance study.

Study headquarters in Madison, WI

Surveys will be sent via the internet.

Sponsors

HOPE Trials the research arm of Quincy Bioscience