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American Migraine Prevention Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Dynamic Health Resources.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363506
First Posted: August 15, 2006
Last Update Posted: April 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dynamic Health Resources
  Purpose
The purpose of this study is to evaluate the use of nutritional supplementation and dietary management for the reduction in frequency, duration, and intensity of migraine headache pain.

Condition Intervention Phase
Migraine Disorders Behavioral: Serotona Plus and dietary behavior management Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nutritional Based Protocol to Balance Serotonin for the Prevention or Reduced Frequency/Duration/Intensity of Migraines

Resource links provided by NLM:


Further study details as provided by Dynamic Health Resources:

Primary Outcome Measures:
  • Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days

Estimated Enrollment: 1000
Study Start Date: January 2006
Estimated Study Completion Date: December 2008
Detailed Description:

AMPS, the American Migraine Prevention Study Program is a home based nutritional study for migraine prevention. It is designed to evaluate a nutritional supplement along with proper diet, and trigger management that may prevent migraines or reduce the frequency, duration and intensity of migraine headache pain.

The AMPS Program is availalbe nationwide. It is a home based study program.

During the three month study period, participants will be asked to take a daily nutritional supplement and follow a recommended diet to avoid potential migraine triggers. Participants will be asked to maintain a headache log and submit headache questionnaires at the beginning and end of the study. Participants do not have to travel and can participate from their current location.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of migraines
  • Ages 18-72
  • Migraines more than once per month
  • Diagnosed migraines for more than one year

Exclusion Criteria:

  • Pregnant/nursing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363506


Contacts
Contact: John J Carvalho, MBA 757-721-7781 jjc@dynamichealthresources.com
Contact: Katherine huffman, MA 571-334-9154 Katherine@dynamichealthresources.com

Locations
United States, Virginia
Nationwide home based study program Recruiting
Chesapeake, Virginia, United States, 23320
Contact: John J Carvalho, MBA    757-572-7781    jjc@dynamichealthresources.com   
Contact: Katherine huffman, MA    571-334-9154    Katherine@DynamicHealthResources.com   
Principal Investigator: Dr. John A Allocca, PhD, ScD         
Sponsors and Collaborators
Dynamic Health Resources
Investigators
Study Chair: John J Carvalho, MBA Dynamic Health Resources
  More Information

ClinicalTrials.gov Identifier: NCT00363506     History of Changes
Other Study ID Numbers: DHR-757962-7081
First Submitted: August 9, 2006
First Posted: August 15, 2006
Last Update Posted: April 24, 2008
Last Verified: April 2008

Keywords provided by Dynamic Health Resources:
nutritional
C10.228.140.546.399.750

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases