Frovatriptan and Menstrual Migraine

NCT ID: NCT01114711

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-05-31

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.

Conditions

Frovatriptan; Menstrual Migraine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Frovatriptan

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

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Borsook, MD, PhD

Director, Pain and Analgesia Imaging Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Borsook, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

Neuroimaging Center, McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

400479

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2009-P-001452

Identifier Type: -

Identifier Source: org_study_id