Theramine® in the Prevention of Migraine Headache
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Headache
Intervention: Theramine (medical food/old drug); Placebo (l-alanine)
Intervention description: Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.; Theramine like placebo comparator
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of Theramine® as a preventative for
      migraine headaches.
    

Eligibility criteria:

        INCLUSION CRITERIA: The inclusion criteria will be the following:

          1. (male and female) 18-65 years of age

          2. Women of child-bearing potential, has a negative pregnancy test (urine or serum) at
             screen, and agrees to one of the following:

               1. Complete abstinence from intercourse from 2 weeks prior to administration of the
                  investigational product, throughout the study, and for a time interval (5 days)
                  after completion or premature discontinuation from the study,

               2. History of bilateral tubal ligation,

               3. Hormonal Contraception (oral, patch, etc.) as approved by the Investigator,

               4. Sterilization of male partner; or,

               5. Any intrauterine device (IUD),

               6. Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or
                  spermicide plus a female diaphragm); or,

               7. Any other barrier methods (only if used in combination with any of the above
                  acceptable methods);

          3. Diagnosis of migraine headache (ICHD 1.1-1.5) as determined by criteria established by
             the International Classification of Headache Disorder (ICHD-II).

          4. 4-14 days per month with migraine averaged over past 3 months, as self reported by
             subject.

          5. Migraines symptoms must have been present for at least one year prior to enrollment in
             the study.

          6. The onset of migraine symptoms must have occurred before age 50.

          7. Is medically stable as determined by the Investigator.

          8. If taking any concomitant preventative medication(s), is on a stabilized dosage at the
             discretion of the investigator.

          9. Is willing to stay on current preventative medication(s) for the duration of the
             study.

         10. Is able to take oral medication, adhere to the medication regimens and perform study
             procedures.

         11. Is able to understand and communicate intelligibly with the study observer.

         12. Is able to read and comprehend written instructions and be willing to complete all
             procedures and assessments required by this protocol.

         13. Is able to demonstrate the willingness to participate by signing and understanding an
             informed consent after full explanation of the study.

        EXCLUSION CRITERIA: The exclusion criteria will be the following:

          1. Is pregnant, actively trying to become pregnant, or breast feeding.

          2. A diagnosis of medication overuse headaches as determined by the investigator.

          3. Chronic medical illnesses (eg. lupus, malignancy, infections, sarcoidosis) that could
             potentially modulate the frequency of migraine headache.

          4. Has evidence of alcohol or substance abuse within the last year or any concurrent
             medical or psychiatric condition which, in the investigator's judgment, will likely
             interfere with the study conduct, subject cooperation, or evaluation and
             interpretation of the study results, or which otherwise contraindicates participation
             in this clinical trial.

          5. Chronic daily headache (≥ 15 days per month with headache of any kind) averaged over
             past 3 months.

          6. Abnormal creatinine, BUN, and/or Liver Function Enzymes will be assessed and exclusion
             will be at the discretion of the Investigator.

          7. Allergy or hypersensitivity to any ingredients in Theramine® including
             arginine-containing preparations and whey protein (milk).