The Role of Theramine® in the Prevention of Migraine Headache: A Pilot Study

This randomized double blind placebo-controlled study will enroll approximately 80 otherwise healthy subjects with a diagnosis of migraine headache. All subjects will be medically stable at enrollment and be on a stabilized dosage of daily medications.

The study duration will be approximately four months and the study will be divided into 3 phases (described below). Participants will complete daily headache diaries throughout all phases of the study, which will assess the presence or absence of headache as well as its characteristics (e.g. unilateral vs. bilateral, worse with exertion, moderate to severe intensity, throbbing quality, presence of associated symptoms [nausea, vomiting, photophobia, phonophobia]. The peak severity of the headaches will also be rated on a 0-10 scale each day. The characteristics of the headaches will enable us to classify headache days into those with migraine and non-migraine headaches. A migraine day will be considered any day with a moderate to severe headache that has one of the following two associated symptoms: 1) both photophobia and phonophobia or 2) nausea or vomiting. A headache day will be defined as the presence of any headache regardless of its characteristics.

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.

Phase 1: During this phase, participants will complete daily headache diaries for 30 days, but no study medication will be given. This phase will last approximately 1 month and will establish a baseline for the frequency of migraine in the absence of study medication.

Phase 2: Phase 2 will last for 1 month and represents the time period of initiation of the study medication. Participants will be randomized to either 2 capsules of Theramine® BID (Group A) or matching placebo (Group B) in a 1:1 treatment allocation. Subjects will take the study medications (Theramine® or placebo) for the duration of this phase and complete daily headache diaries. Participants will also complete a Headache Impact Questionnaire (HIT-6), which is a validated questionnaire to assess headache related disability in the last month. This phase will not be included in the data analysis as it may take 1 month to see a treatment effect after starting a preventative.