Frovatriptan and Menstrual Migraine (FROVA)

This study has been terminated.
(A sister study using Frova at a 10 mg dose had adverse effects.)
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by:
Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01114711
First received: April 29, 2010
Last updated: May 26, 2010
Last verified: May 2010
  Purpose

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
Frovatriptan
Menstrual Migraine

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Mapping CNS Changes to Frovatriptan Administration in Acute Treatment of Prodrome or Preventative Treatment of Menstrual Migraine (MM)

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Enrollment: 24
Study Start Date: April 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Frovatriptan
All subjects will be taking Frovatriptan tablets within 48 hours prior to the scan session (Visit 2).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114711

Locations
United States, Massachusetts
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
  More Information

No publications provided

Responsible Party: David Borsook, MD, PhD; Principal Investigator, McLean Hospital
ClinicalTrials.gov Identifier: NCT01114711     History of Changes
Other Study ID Numbers: 2009-P-001452, 400479
Study First Received: April 29, 2010
Last Updated: May 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Mclean Hospital:
Menstrual Migraine
Frova
Imaging
fMRI
Pain

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Frovatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014