Theramine® in the Prevention of Migraine Headache

NCT01944059 | Terminated Phase 4 Results DMC

• 1 other identifier: VM-2013-001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine Headaches

Outcome Measures

Primary Outcomes (1)

• Number of Migraine/Headache Days

  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.

  4-6 months

Secondary Outcomes (2)

• Percent Change in Migraine and Headache Frequency

  4-6 months

• HIT-6

  4-6 months

Study Arms (2)

Theramine

ACTIVE COMPARATOR

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)

placebo (l-alanine)

PLACEBO COMPARATOR

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)

Interventions

Theramine (medical food/old drug) DRUG

Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.

Theramine

Placebo (l-alanine) OTHER

Theramine like placebo comparator

placebo (l-alanine)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (male and female) 18-65 years of age
• Women of child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and agrees to one of the following:
• 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,
• History of bilateral tubal ligation,
• Hormonal Contraception (oral, patch, etc.) as approved by the Investigator,
• Sterilization of male partner; or,
• Any intrauterine device (IUD),
• Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or spermicide plus a female diaphragm); or,
• Any other barrier methods (only if used in combination with any of the above acceptable methods);
• Diagnosis of migraine headache (ICHD 1.1-1.5) as determined by criteria established by the International Classification of Headache Disorder (ICHD-II).
• days per month with migraine averaged over past 3 months, as self reported by subject.
• Migraines symptoms must have been present for at least one year prior to enrollment in the study.
• The onset of migraine symptoms must have occurred before age 50.
• Is medically stable as determined by the Investigator.
• If taking any concomitant preventative medication(s), is on a stabilized dosage at the discretion of the investigator.

You may not qualify if:

• Is pregnant, actively trying to become pregnant, or breast feeding.
• A diagnosis of medication overuse headaches as determined by the investigator.
• Chronic medical illnesses (eg. lupus, malignancy, infections, sarcoidosis) that could potentially modulate the frequency of migraine headache.
• 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.
• Chronic daily headache (≥ 15 days per month with headache of any kind) averaged over past 3 months.
• Allergy or hypersensitivity to any ingredients in Theramine® including arginine-containing preparations and whey protein (milk).

Sponsors & Collaborators

• Vincent Martin, MD: lead
• Targeted Medical Pharma: collaborator

Study Sites (1)

University Cincinnati Physicians Company

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Alanine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Vincent Martin, MD
• Organization: University Cincinnati Physicians Company

vincent.martin@uc.edu

513-558-7581

Study Officials

• Vincent Martin, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vincent Martin MD, University of Cincinnati Physicians Company

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2015
• Last Updated: May 5, 2016
• Results First Posted: May 4, 2016

Record last verified: 2016-05

Locations

US (1)