FrovatriptanFROVANCT01114711
Frovatriptan and Menstrual Migraine
An observational study of Frovatriptan and Menstrual Migraine, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Frovatriptan, Menstrual Migraine
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- Weight, <285 pounds
- Not claustrophobic
- No contraindication to taking triptans
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuroimaging Center, McLean Hospital
Belmont, Massachusetts, 02478
About this study
Official title: Mapping CNS Changes to Frovatriptan Administration in Acute Treatment of Prodrome or Preventative Treatment of Menstrual Migraine (MM)
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
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Frovatriptan | All subjects will be taking Frovatriptan tablets within 48 hours prior to the scan session (Visit 2). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: A sister study using Frova at a 10 mg dose had adverse effects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrovatriptanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Responsible party
- Principal investigator, David Borsook, MD, PhD, Mclean Hospital
- Investigators
- David Borsook, MD, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114711
- Sponsor's protocol ID
- 2009-P-001452
- Other IDs
- 400479
- Acronym
- FROVA
- Status last verified
- Apr 2018
- First submitted
- 29 Apr 2010
- Last updated
- 12 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping CNS Changes to Frovatriptan Administration in Acute Treatment of Prodrome or Preventative Treatment of Menstrual Migraine (MM)
- ClinicalTrials.gov ID
- NCT01114711
- Acronym / sponsor ID
- FROVA / 2009-P-001452
- Conditions
- Frovatriptan, Menstrual Migraine
- Keywords
- Menstrual Migraine, Frova, Imaging, fMRI, Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: A sister study using Frova at a 10 mg dose had adverse effects.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frovatriptan | – | –All subjects will be taking Frovatriptan tablets within 48 hours prior to the scan session (Visit 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: A sister study using Frova at a 10 mg dose had adverse effects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Borsook, MD, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frovatriptan and Menstrual Migraine, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: A sister study using Frova at a 10 mg dose had adverse effects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.