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Frovatriptan and Menstrual Migraine (FROVA)

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ClinicalTrials.gov Identifier: NCT01114711
Recruitment Status : Terminated (A sister study using Frova at a 10 mg dose had adverse effects.)
First Posted : May 3, 2010
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
David Borsook, MD, PhD, Mclean Hospital

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
Frovatriptan Menstrual Migraine

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 : April 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: David Borsook, MD, PhD, Director, Pain and Analgesia Imaging Group, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01114711     History of Changes
Other Study ID Numbers: 2009-P-001452
400479 ( Other Grant/Funding Number: Endo Pharmaceuticals, Inc. )
First Posted: May 3, 2010    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Keywords provided by David Borsook, MD, PhD, Mclean Hospital:
Menstrual Migraine
Frova
Imaging
fMRI
Pain

Additional relevant MeSH terms:
Menstruation Disturbances
Migraine Disorders
Premenstrual Syndrome
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Frovatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs