Clinical trial NCT01114711: Frovatriptan and Menstrual Migraine
Official title: Mapping CNS Changes to Frovatriptan Administration in Acute Treatment of Prodrome or Preventative Treatment of Menstrual Migraine (MM)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Frovatriptan
Menstrual Migraine
Keywords: Menstrual Migraine
Frova
Imaging
fMRI
Pain
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2010-05-03
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: Neuroimaging Center, McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: David Borsook, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: