Back to resultsAmerican Migraine Prevention Study
Primary Purpose
Migraine Disorders
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Serotona Plus and dietary behavior management
Sponsored by
About this trial
This is an interventional prevention trial for Migraine Disorders focused on measuring nutritional, C10.228.140.546.399.750
Eligibility 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
Sites / Locations
- Nationwide home based study programRecruiting
Outcomes
Primary Outcome Measures
Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days
Secondary Outcome Measures
Full Information
NCT ID
NCT00363506
First Posted
August 9, 2006
Last Updated
April 22, 2008
Sponsor
Dynamic Health Resources
1. Study Identification
Unique Protocol Identification Number
NCT00363506
Brief Title
American Migraine Prevention Study
Official Title
Nutritional Based Protocol to Balance Serotonin for the Prevention or Reduced Frequency/Duration/Intensity of Migraines
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Dynamic Health Resources
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
nutritional, C10.228.140.546.399.750
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Serotona Plus and dietary behavior management
Primary Outcome Measure Information:
Title
Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John J Carvalho, MBA
Phone
757-721-7781
Email
jjc@dynamichealthresources.com
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine huffman, MA
Phone
571-334-9154
Email
Katherine@dynamichealthresources.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Carvalho, MBA
Organizational Affiliation
Dynamic Health Resources
Official's Role
Study Chair
Facility Information:
Facility Name
Nationwide home based study program
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John J Carvalho, MBA
Phone
757-572-7781
Email
jjc@dynamichealthresources.com
First Name & Middle Initial & Last Name & Degree
Katherine huffman, MA
Phone
571-334-9154
Email
Katherine@DynamicHealthResources.com
First Name & Middle Initial & Last Name & Degree
Dr. John A Allocca, PhD, ScD
12. IPD Sharing Statement
Learn more about this trial
American Migraine Prevention Study
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