Frovatriptan and Menstrual Migraine (FROVA)

Mapping CNS Changes to Frovatriptan Administration in Acute Treatment of Prodrome or Preventative Treatment of Menstrual Migraine (MM)

We are looking for women who suffer from menstrual migraine to participate in a 2-visit migraine brain imaging research study. Our goal is to see how the menstrual migraine brain's pain pathways function when the migraineur has been taking Frovatriptan. During the screening visit (Visit 1) participants will sign the informed consent form, complete questionnaires, meet with the study physician, and have QST (quantitative sensory testing: to determine your pain thresholds for a heat stimulus) performed. For Visit 2's MRI scan, subjects will be asked to lie very still while the scan is occurring. In some parts, they will not have to do anything, while in others they will be asked to rate pain and unpleasantness for brush and thermal stimuli. Participants are compensated for both visits.

Study Overview

• Status: Terminated
• Conditions: Menstrual Migraine; Frovatriptan

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Neuroimaging Center, McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Females who suffer from menstrual migraine who are over the age of 18 and have not yet experienced menopause are the study population.

Description

Inclusion Criteria:

• Female
• Regular Menstrual Phase
• Menstrual Migraine
• No significant medical history (Significant medical history of such as seizure disorder, diabetes, alcoholism, cardiac disease including coronary artery disease, psychiatric problems; drug addiction, respiratory problems, liver disease, etc.)
• No significant medication history, except for migraine
• All patients will be currently taking or have previously taken triptan medications for migraine
• Weight, <285 pounds
• Not claustrophobic
• No contraindication to taking triptans

Exclusion Criteria:

• Age <18
• Significant medical problems (aside from pain before, during and after migraine episodes)
• Positive drug of abuse screen (excluding medications currently prescribed for their clinical condition, e.g. opioids, benzodiazepines, etc.)
• Positive alcohol screen
• Women taking oral contraceptives
• Claustrophobia
• History of dermatological hypersensitivity in the facial area
• Positive history of cardiac problems/ abnormalities seen in EKG at initial screening visit
• Pregnancy
• Sensory loss detected on Quantitative Sensory Testing at screening
• Significant alcohol history (ingestion of 5 or more glasses (> 40 oz) of alcohol per week)
• Metal implants of any type (including dental bridges, crowns, retainers, orthodontic devices e.g. braces, etc.)
• Tattoos containing metallic ink on the neck, shoulders, upper arm and head (which could become heated up in the scanner, and potentially cause blistering or burning)
• Cardiac pacemakers
• Aneurysm clips and other vascular stents, filters, clips or other devices
• Prosthetic heart valves
• Other prostheses
• Neuro-stimulator devices
• Implanted infusion pumps
• Cochlear (ear) implants
• Ocular (eye) implants or known metal fragments in eyes
• Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)
• Other metallic surgical hardware in vital areas
• Use of any of the following medications:
• Propanolol/ Inderol
• SSRI's: citalopram/ Celexa, Lepraxo, paroxetine/ Paxil, fluoxetine/ Prozac, Sarafem, Symbyax, sertraline/ Zoloft, Fluvoxamine/ Luvox
• SNRI's: duloxetine/ Cymbalta, venlafaxine/ Effexor
• triptans: sumatriptan/ Imitrex, naratriptan/ Amerge, zolmitriptan/ Zomig, rizatriptan/ Maxalt, eletriptan/ Relpax, almotriptan/ Axert
• ergotamine type medicines: Bellergal, Cafergot, Ergomar, Wiraine, Migranal/ DHE45, Sansert
• ketoconazole (Nizoral, Fungoral)
• itraconazole (Sporanox)
• ritonavir (Norvir)
• erythromycin (Erythrocin)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Frovatriptan; All subjects will be taking Frovatriptan tablets within 48 hours prior to the scan session (Visit 2).

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (ESTIMATE): May 3, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Imaging; Pain; fMRI; Menstrual Migraine; Frova
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Menstruation Disturbances; Migraine Disorders; Premenstrual Syndrome
• Other Study ID Numbers: 2009-P-001452; 400479 (OTHER_GRANT: Endo Pharmaceuticals, Inc.)