Migraine HeadachesPhase 4NCT01944059
Theramine® in the Prevention of Migraine Headache
A Phase 4 study testing Theramine (medical food/old drug) in people with Migraine Headaches, run by Vincent Martin, MD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of Theramine® as a preventative for migraine headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headaches
- What is being tested?
- Theramine (medical food/old drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
INCLUSION CRITERIA: The inclusion criteria will be the following:
- (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).
- 4-14 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.
- Is willing to stay on current preventative medication(s) for the duration of the study.
- Is able to take oral medication, adhere to the medication regimens and perform study procedures.
- Is able to understand and communicate intelligibly with the study observer.
- Is able to read and comprehend written instructions and be willing to complete all procedures and assessments required by this protocol.
- 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:
- 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.
- Abnormal creatinine, BUN, and/or Liver Function Enzymes will be assessed and exclusion will be at the discretion of the Investigator.
- Allergy or hypersensitivity to any ingredients in Theramine® including arginine-containing preparations and whey protein (milk).
Trial locations and contacts
1 site in 1 country.
United States1 site
University Cincinnati Physicians Company
Cincinnati, Ohio, 45219
About this study
Official title: The Role of Theramine® in the Prevention of Migraine Headache: A Pilot Study
The purpose of this study is to evaluate the efficacy of Theramine® as a preventative for migraine headaches.
Read the detailed description
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.
Phase 3: Phase 3 will last 2 months and represents the time period during which the efficacy of Theramine® will be determined. Participants will continue to complete headache diaries and will continue to Theramine® or placebo during this phase. They will also complete a HIT-6 questionnaire.
There will be four study visits, which will be described below.
Office Visit 1: Following informed consent, a physical and neurological exam and vital signs will be completed. A urine or serum pregnancy test will be collected by all female subjects of childbearing potential. Routine labs (electrolyte panel with creatinine, liver enzyme profile and CRP), will be collected. Eligible participants will be trained during the visit to complete daily headache diaries. It is anticipated that this visit will last for 2 hours.
Office Visit 2: At Visit 2, research staff will review the diary information completed during phase 1. Subjects who complete a minimum of 25 out of 30 days of their daily headache diary will be asked to continue participation with Phase 2 of the study. They will receive 268 capsules of study medication (enough for 67 days) and will be instructed to record any adverse events experienced from taking the study medication. During the office visit, subjects will complete the HIT-6 questionnaire. It is anticipated that this visit will last for 1 hour.
Office Visit 3: At Visit 3, research staff will review the diary information completed during phase 1. Subjects who complete a minimum of 50 out of 60 days of their daily headache diary and took 80% of their study medication will be asked to complete the last month of the study. They will receive 134 capsules of study medication (enough for 33 days) and will be instructed to record any adverse events experienced from taking the study medication. During the office visit, subjects will complete the HIT-6 questionnaire. It is anticipated that this visit will last for 1 hour.
Office Visit 4: At Visit 4, medical and medication history will be updated and adverse events collected. A urine or serum pregnancy test will be collected by any subjects of childbearing potential if study medication was taken and a blood test for CRP will be done. Pregnancy testing and CRP may be completed at Visit 3 if subjects will not be returning for a Visit 4. Study medication accountability and compliance will be assessed by counting all the pills that had been returned by the study participant. Subjects will complete the HIT-6 questionnaire. It is anticipated that this visit will last for 1 hour.
The study coordinator will contact participants by phone, email, mail or texting at least one time per month to schedule appointments and discuss any questions. This study is minimal risk and subjects will not need to return study drug if they withdraw or are withdrawn by the investigator. Information regarding study medication that is not returned for any reason will be documented in the study medication accountability log. Lost to follow up will be defined as any subject who has failed to contact the study coordinator after the coordinator has made six attempts to contact the subject over a 30 day period.
The Investigator will access in a case-by-case basis should a subject request additional days to complete the study or request replacement study medication due to loss. Documentation of such requests and outcomes will be maintained in subject's study file.
- Conditions
- Migraine Headaches
- Being tested
- Theramine (medical food/old drug), Placebo (l-alanine)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theramine (medical food/old drug)Drug
Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.
Placebo (l-alanine)Other
Theramine like placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo (l-alanine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 months
Secondary outcomes (2)
Percent Change in Migraine and Headache Frequency
The percent change in migraine and headache frequency will be defined as [frequency/baseline phase - frequency/treatment phase] divided by [frequency/baseline phase].
Measured: 4-6 months
HIT-6
Differences in the scores for the HIT-6 disability inventory between baseline and the last study visit will be analyzed.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionOct 2015
Why it stopped: Funding Discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine HeadachesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vincent Martin, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Targeted Medical Pharma
- Responsible party
- Sponsor-investigator, Vincent Martin, MD, Targeted Medical Pharma
- Investigators
- Vincent Martin, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944059
- Sponsor's protocol ID
- VM-2013-001
- Status last verified
- May 2016
- First submitted
- 12 Sep 2013
- Last updated
- 5 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Theramine® in the Prevention of Migraine Headache: A Pilot Study
- ClinicalTrials.gov ID
- NCT01944059
- Acronym / sponsor ID
- VM-2013-001
- Conditions
- Migraine Headaches
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Discontinued
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vincent Martin, MDIndustry (pharma, biotech, devices)
- Collaborators
- Targeted Medical Pharma
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 4 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of Theramine® as a preventative for migraine headaches.
Detailed description
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.
Phase 3: Phase 3 will last 2 months and represents the time period during which the efficacy of Theramine® will be determined. Participants will continue to complete headache diaries and will continue to Theramine® or placebo during this phase. They will also complete a HIT-6 questionnaire.
There will be four study visits, which will be described below.
Office Visit 1: Following informed consent, a physical and neurological exam and vital signs will be completed. A urine or serum pregnancy test will be collected by all female subjects of childbearing potential. Routine labs (electrolyte panel with creatinine, liver enzyme profile and CRP), will be collected. Eligible participants will be trained during the visit to complete daily headache diaries. It is anticipated that this visit will last for 2 hours.
Office Visit 2: At Visit 2, research staff will review the diary information completed during phase 1. Subjects who complete a minimum of 25 out of 30 days of their daily headache diary will be asked to continue participation with Phase 2 of the study. They will receive 268 capsules of study medication (enough for 67 days) and will be instructed to record any adverse events experienced from taking the study medication. During the office visit, subjects will complete the HIT-6 questionnaire. It is anticipated that this visit will last for 1 hour.
Office Visit 3: At Visit 3, research staff will review the diary information completed during phase 1. Subjects who complete a minimum of 50 out of 60 days of their daily headache diary and took 80% of their study medication will be asked to complete the last month of the study. They will receive 134 capsules of study medication (enough for 33 days) and will be instructed to record any adverse events experienced from taking the study medication. During the office visit, subjects will complete the HIT-6 questionnaire. It is anticipated that this visit will last for 1 hour.
Office Visit 4: At Visit 4, medical and medication history will be updated and adverse events collected. A urine or serum pregnancy test will be collected by any subjects of childbearing potential if study medication was taken and a blood test for CRP will be done. Pregnancy testing and CRP may be completed at Visit 3 if subjects will not be returning for a Visit 4. Study medication accountability and compliance will be assessed by counting all the pills that had been returned by the study participant. Subjects will complete the HIT-6 questionnaire. It is anticipated that this visit will last for 1 hour.
The study coordinator will contact participants by phone, email, mail or texting at least one time per month to schedule appointments and discuss any questions. This study is minimal risk and subjects will not need to return study drug if they withdraw or are withdrawn by the investigator. Information regarding study medication that is not returned for any reason will be documented in the study medication accountability log. Lost to follow up will be defined as any subject who has failed to contact the study coordinator after the coordinator has made six attempts to contact the subject over a 30 day period.
The Investigator will access in a case-by-case basis should a subject request additional days to complete the study or request replacement study medication due to loss. Documentation of such requests and outcomes will be maintained in subject's study file.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theramine | Active comparator | Drug: Theramine (medical food/old drug)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. |
| placebo (l-alanine) | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theramine (medical food/old drug)Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors. | Drug | Theramine |
| Placebo (l-alanine)Theramine like placebo comparator | Other | placebo (l-alanine) |
Primary outcome
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.
2 secondary outcomes
Percent Change in Migraine and Headache Frequency
Time frame: 4-6 months
HIT-6
Time frame: 4-6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Martin, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Theramine (medical food/old drug) in people with Migraine Headaches, run by Vincent Martin, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Migraine/Headache Days (time frame: 4-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.