Clinical Trials Logo
  1. Home
  2. Migraine Disorders
  3. NCT00363506
  4. Details
NCT00363506 Clinical Trial

American Migraine Prevention Study

Migraine Disorders Clinical Trial

Official title:
Nutritional Based Protocol to Balance Serotonin for the Prevention or Reduced Frequency/Duration/Intensity of Migraines

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00363506
Other study ID # DHR-757962-7081
Secondary ID
Status Recruiting
Phase Phase 4
First received August 9, 2006
Last updated April 22, 2008
Start date January 2006
Est. completion date December 2008

Study information
Verified date April 2008
Source Dynamic Health Resources
Contact John J Carvalho, MBA
Phone 757-721-7781
Email jjc@dynamichealthresources.com
Is FDA regulated No
Health authority United States: Mid-Atlantic Institutional Review Board
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 72 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Serotona Plus and dietary behavior management

Locations
Country Name City State
United States Nationwide home based study program Chesapeake Virginia

Sponsors (1)
Lead Sponsor Collaborator
Dynamic Health Resources

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days
See also
  Status Clinical Trial Phase
Completed NCT01432379 - BOTOX® Prophylaxis in Patients With Chronic Migraine
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Recruiting NCT05048914 - Migraine Abortive Treatment
Completed NCT03662295 - Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
Completed NCT02766517 - Biomarker Study in Participants With Migraine Early Phase 1
Completed NCT00963937 - Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents Phase 3
Not yet recruiting NCT03632928 - Day to Day Variation of Pressure Pain Threshold and Muscle Hardness
Completed NCT02559895 - A Multicenter Assessment of ALD403 in Frequent Episodic Migraine Phase 3
Completed NCT01435941 - Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine N/A
Completed NCT00743015 - Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks Phase 1
Completed NCT01376141 - Drug Use Investigation for IMIGRAN Tablet N/A
Completed NCT02183688 - Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients Phase 3
Completed NCT06061588 - "Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches" N/A
Completed NCT03588364 - The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine N/A
Completed NCT04091321 - Association Between Chronic Headache and Back Pain With Childbirth
Completed NCT00385008 - TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine Phase 3
Active, not recruiting NCT05888298 - Proximal and Distal Approach GON RFT in Migraine N/A
Completed NCT03435185 - Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients N/A
Recruiting NCT06459635 - Migraine Attack Pain Phase Prediction Study
Completed NCT02565186 - An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine Phase 3