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American Migraine Prevention Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Dynamic Health Resources.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dynamic Health Resources
ClinicalTrials.gov Identifier:
NCT00363506
First received: August 9, 2006
Last updated: April 22, 2008
Last verified: April 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00363506     History of Changes
Other Study ID Numbers: DHR-757962-7081
Study First Received: August 9, 2006
Last Updated: April 22, 2008
Health Authority: United States: Mid-Atlantic Institutional Review Board

Keywords provided by Dynamic Health Resources:
nutritional
C10.228.140.546.399.750

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

ClinicalTrials.gov processed this record on November 25, 2014