MS HOPE Trial

A randomized, double-blind, placebo controlled Quality of Life Study of the Effect of Apoaequorin Dietary Supplement, on Quality of Life Measures and Expectations with Regard to Aging in Participants with Multiple Sclerosis

The purpose of this study is to determine if an apoaequorin dietary supplement improves quality of life scores and improves aging expectations for participants with multiple sclerosis.

Primary Outcome Measure

Changes in ratings for Multiple Sclerosis specific quality of life survey based instruments including MSQOL-54, Modified Fatigue Impact Scale (MFIS), and MSIS-29 over six months.

Estimated Enrollment: 250
Study Enrollment Start Date: June 1, 2010
Estimated Study Completion Date: July 1, 2011
Study Length: six months

Rationale

The World Health Organization estimates approximately 2.5 million people have multiple sclerosis (MS) worldwide and 500,000 in the United States. MS is a chronic, degenerative, inflammatory disorder that affects nerves in the brain and spinal cord. The nerve cell’s inability to regulate calcium ions is a key component of cellular dysfunction and subsequent cell death which may contribute to demyelination. The cause of calcium dysregulation in MS is unknown, however, there is some research which suggests that a gene mutation in MS patients causes excessively high levels of intracellular calcium in nerve cells which leads to activated T cells triggering an over stimulated immune response.

Apoaequorin is a naturally-occurring calcium-binding protein and is very similar to endogenous proteins which have been shown to deplete with age. In laboratory experiments conducted at the University of Wisconsin-Milwaukee, apoaequorin proved highly neuroprotective. In human trials of generally healthy adults, apoaequorin has shown to help cognition, sleep, mood, and other quality of life parameters. Apoaequorin is a safe non-toxic oral supplement which has been available for 3 years.

Case reports gathered from apoaequorin dietary supplement users with MS have seen improvements in some MS symptoms.

Eligibilty

Ages Eligible for Study: 21 years to 80 years
Genders Eligible for Study: Male or Female
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

  1. Diagnosis of Multiple Sclerosis
  2. Ability to complete study questionnaires
  3. Ability to connect to the internet and possess an email address

Exclusion Criteria:

  1. Any disability acquired from trauma or another illness that could interfere with the evaluation of disability due to MS.
  2. Major systemic disease that cannot be treated or adequately controlled by therapy.
  3. Subject is unable to comply with dosing instructions.
  4. Psychiatric or cognitive conditions that compromise the subject’s ability to understand patient information, to give informed consent, to comply with the trial protocol, or to complete the study.
  5. Subject who, in the investigator’s opinion, will not comply with the study procedure.
  6. Ongoing pregnancy or an intent to become pregnant during the study

Locations

The study can be participated in from anywhere throughout the United States. Surveys will be sent via the internet.

Sponsors

HOPE Trials the research arm of Quincy Bioscience

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