Migraine DisordersPhase 4NCT00363506
American Migraine Prevention Study
A Phase 4 study testing Serotona Plus and dietary behavior management in people with Migraine Disorders, run by Dynamic Health Resources at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Serotona Plus and dietary behavior management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of migraines
- Ages 18-72
- Migraines more than once per month
- Diagnosed migraines for more than one year
Who cannot join
- Pregnant/nursing
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Nationwide home based study program
Chesapeake, Virginia, 23320
John J Carvalho, MBA, 757-572-7781, jjc@dynamichealthresources.com
Katherine huffman, MA, 571-334-9154, Katherine@DynamicHealthResources.com
About this study
Official title: Nutritional Based Protocol to Balance Serotonin for the Prevention or Reduced Frequency/Duration/Intensity of Migraines
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.
Read the 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.
- Conditions
- Migraine Disorders
- Being tested
- Serotona Plus and dietary behavior management
- Keywords
- nutritional, C10.228.140.546.399.750
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serotona Plus and dietary behavior managementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJan 2006
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynamic Health Resources
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John J Carvalho, MBA, Study chair, Dynamic Health Resources
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363506
- Sponsor's protocol ID
- DHR-757962-7081
- Status last verified
- Apr 2008
- First submitted
- 9 Aug 2006
- Last updated
- 24 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Based Protocol to Balance Serotonin for the Prevention or Reduced Frequency/Duration/Intensity of Migraines
- ClinicalTrials.gov ID
- NCT00363506
- Acronym / sponsor ID
- DHR-757962-7081
- Conditions
- Migraine Disorders
- Keywords
- nutritional, C10.228.140.546.399.750
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dynamic Health ResourcesIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of migraines
- Ages 18-72
- Migraines more than once per month
- Diagnosed migraines for more than one year
Key exclusion criteria (1 listed)
- Pregnant/nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serotona Plus and dietary behavior management | Behavioural | – |
Primary outcome
Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Carvalho, MBA study chair
Dynamic Health Resources
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Serotona Plus and dietary behavior management in people with Migraine Disorders, run by Dynamic Health Resources at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John J Carvalho, MBA (757-721-7781, jjc@dynamichealthresources.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2008.