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Theramine® in the Prevention of Migraine Headache

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ClinicalTrials.gov Identifier: NCT01944059
Recruitment Status : Terminated (Funding Discontinued)
First Posted : September 17, 2013
Results First Posted : May 4, 2016
Last Update Posted : May 5, 2016
Sponsor:
Collaborator:
Targeted Medical Pharma
Information provided by (Responsible Party):
Vincent Martin, MD, Targeted Medical Pharma

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

Condition or disease Intervention/treatment Phase
Migraine Headaches Drug: Theramine (medical food/old drug) Other: Placebo (l-alanine) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Theramine® in the Prevention of Migraine Headache: A Pilot Study
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
Drug Information available for: Alanine

Arm Intervention/treatment
Active Comparator: Theramine

2 capsules before breakfast and dinner (BID) for 16 weeks.

Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.

Drug: Theramine (medical food/old drug)
Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.

Placebo Comparator: placebo (l-alanine)

2 capsules before breakfast and dinner (BID) for 16 weeks.

Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.

Other: Placebo (l-alanine)
Theramine like placebo comparator




Primary Outcome Measures :
  1. Number of Migraine/Headache Days [ Time Frame: 4-6 months ]
    The primary outcome measure will be the frequency of migraine and all headache days in the Theramine active group versus the Theramine placebo group during the treatment period.


Secondary Outcome Measures :
  1. Percent Change in Migraine and Headache Frequency [ Time Frame: 4-6 months ]
    The percent change in migraine and headache frequency will be defined as [frequency/baseline phase - frequency/treatment phase] divided by [frequency/baseline phase].

  2. HIT-6 [ Time Frame: 4-6 months ]
    Differences in the scores for the HIT-6 disability inventory between baseline and the last study visit will be analyzed.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944059


Locations
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United States, Ohio
University Cincinnati Physicians Company
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Vincent Martin, MD
Targeted Medical Pharma
Investigators
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Principal Investigator: Vincent Martin, MD University of Cincinnati

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Responsible Party: Vincent Martin, MD, Vincent Martin MD, University of Cincinnati Physicians Company, Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01944059     History of Changes
Other Study ID Numbers: VM-2013-001
First Posted: September 17, 2013    Key Record Dates
Results First Posted: May 4, 2016
Last Update Posted: May 5, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms