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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
Recruitment status was: Recruiting
Sponsor:
Dynamic Health Resources
Information provided by:
Dynamic Health Resources
ClinicalTrials.gov Identifier:
NCT00363506
First received: August 9, 2006
Last updated: April 22, 2008
Last verified: April 2008
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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: 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 |
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 (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
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
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
Additional Information:
| 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 |
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 |
ClinicalTrials.gov processed this record on July 18, 2017