Frovatriptan and Menstrual Migraine

NCT01114711 | Terminated

• 2 other identifiers: 2009-P-001452400479
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Menstrual Migraine; Frova; Imaging; fMRI; Pain

Study Arms (1)

Frovatriptan

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

Neuroimaging Center, McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Borsook, MD, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pain and Analgesia Imaging Group

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 3, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (1)