American Migraine Prevention Study

NCT ID: NCT00363506

Last Updated: 2008-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Migraine Disorders

Keywords

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nutritional C10.228.140.546.399.750

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Serotona Plus and dietary behavior management

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dynamic Health Resources

INDUSTRY

Sponsor Role lead

Principal Investigators

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John J Carvalho, MBA

Role: STUDY_CHAIR

Dynamic Health Resources

Locations

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Nationwide home based study program

Chesapeake, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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John J Carvalho, MBA

Role: CONTACT

Phone: 757-721-7781

Email: [email protected]

Katherine huffman, MA

Role: CONTACT

Phone: 571-334-9154

Email: [email protected]

Facility Contacts

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John J Carvalho, MBA

Role: primary

Katherine huffman, MA

Role: backup

Other Identifiers

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DHR-757962-7081

Identifier Type: -

Identifier Source: org_study_id