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Frovatriptan

Phase 3

Menstrually Associated Migraine | Small molecule | Neurology |BrainsWay Ltd.|Last Updated: Jan 2, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment579

FDA Designations

No designations recorded

Clinical trial landscape

Frovatriptan · 3 trials · 2 indications

Phase 3 3
NCT00475514A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual MigraineMigraine
COMPLETED500 Analytics
NCT01035983Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) HeadachesMigraine
COMPLETED550 Analytics
NCT00644033A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual MigraineMenstrually Associated Migraine
COMPLETED579 Analytics
PHASE3COMPLETED
A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine
MigraineUnlock trial analytics
PHASE3COMPLETED
Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches
MigraineUnlock trial analytics
PHASE3COMPLETED
A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine
Menstrually Associated MigraineUnlock trial analytics

Study Endpoints

Primary Endpoints

Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs
Incidence of all treatment-emergent adverse events (AEs).
9-15 months
Incidence of menstrually associated migraine (MAM) headache in the treated peri-menstrual period (PMP)

Secondary Endpoints

Incidence of MRM headache
Maximum headache intensity
Incidence of moderate or severe MRM headaches
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Frovatriptan 2.5 mgEXPERIMENTALFrovatriptan 2.5 mg tablets administered orally 2 x 2.5 mg twice daily (loading dose) on day 1, followed by 2.5 mg twice daily days 2 to 6.
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -
3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Frovatriptan 2.5mg QDDRUG -
Frovatriptan 2.5 mg BIDDRUG -
placeboDRUG -
Frovatriptan 2.5 mgDRUG -
FrovatriptanDRUG2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache
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Eligibility Criteria

Age Range15 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'

Countries:GermanyHungaryPolandSouth AfricaUnited KingdomUnited States
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Frequently asked questions about Frovatriptan

What is Frovatriptan used for?

Frovatriptan is a small molecule drug used for the prevention of menstrually associated migraine and migraine. It is being developed by BrainsWay Ltd. (BWAY) and is currently in Phase 3 clinical development, though the listed trials are all completed.

What does Frovatriptan target?

Frovatriptan is a triptan that works by binding to serotonin receptors, specifically the 5-HT1B and 5-HT1D receptors, to constrict cranial blood vessels and inhibit the release of pro-inflammatory neuropeptides, thereby relieving migraine symptoms.

Who makes Frovatriptan?

Frovatriptan is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The drug is currently in Phase 3 clinical development for the prevention of menstrually associated migraine and migraine.

What phase is Frovatriptan in?

Frovatriptan is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three Phase 3 trials listed have been completed, with a total enrollment of 1,050 participants.

What clinical trials is Frovatriptan in?

Frovatriptan has been studied in three completed Phase 3 trials: NCT00475514, NCT00644033, and NCT01035983. These trials evaluated the efficacy and safety of frovatriptan for the prevention of menstrual migraine and menstrually associated migraine, enrolling a total of 1,050 female participants.

Is Frovatriptan the same as other migraine medications?

Frovatriptan is a triptan class medication, similar to other drugs in its class, but it is a distinct chemical entity. It is specifically being studied for the intermittent prevention of menstrually associated migraine, a niche indication within the broader migraine treatment landscape.