Theramine® in the Prevention of Migraine Headache

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vincent Martin, MD
• Collaborator: Targeted Medical Pharma

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).