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FROVA: Frovatriptan and Menstrual Migraine

Sponsor
Mclean Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01114711
Collaborator
Endo Pharmaceuticals (Industry)
24
Enrollment
1
Location
30
Duration (Days)
24.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    24 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Mapping CNS Changes to Frovatriptan Administration in Acute Treatment of Prodrome or Preventative Treatment of Menstrual Migraine (MM)
    Study Start Date :
    Apr 1, 2010
    Actual Primary Completion Date :
    May 1, 2010
    Actual Study Completion Date :
    May 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Frovatriptan

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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      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)

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Neuroimaging Center, McLean Hospital Belmont Massachusetts United States 02478

      Sponsors and Collaborators

      • Mclean Hospital
      • Endo Pharmaceuticals

      Investigators

      • Principal Investigator: David Borsook, MD, PhD, Mclean Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      David Borsook, MD, PhD, Director, Pain and Analgesia Imaging Group, Mclean Hospital
      ClinicalTrials.gov Identifier:
      NCT01114711
      Other Study ID Numbers:
      • 2009-P-001452
      • 400479
      First Posted:
      May 3, 2010
      Last Update Posted:
      Apr 12, 2018
      Last Verified:
      Apr 1, 2018
      Keywords provided by David Borsook, MD, PhD, Director, Pain and Analgesia Imaging Group, Mclean Hospital
      Menstrual Migraine
      Frova
      Imaging
      fMRI
      Pain
      Additional relevant MeSH terms:
      Migraine Disorders
      Premenstrual Syndrome

      Study Results

      No Results Posted as of Apr 12, 2018