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Registered drugNo placebo
Study Comparing Amitriptyline, Flunarizine, Topiramate, and Propranolol for Preventing Migraines in Primary Care Patients
Registered drugNo placebo
- Participants:Adults
Flunarizine hydrochloride
- 1 / 1
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About the substance
Table of contents
- What is flunarizine hydrochloride?
- How does flunarizine hydrochloride work?
- Which conditions is flunarizine hydrochloride used or studied for?
- How is flunarizine hydrochloride given?
- What do the clinical trials show?
- What side effects are known?
What is flunarizine hydrochloride?
Flunarizine hydrochloride is a medicine that belongs to several drug classes. It is described as a calcium channel blocker, a vasodilator, an antivertigo agent, and a histamine H1 receptor antagonist (an antihistamine).[3] Its Anatomical Therapeutic Chemical (ATC) classification code is N07CA03, which places it among antivertigo preparations.[4] The substance is also known as flunarizine, flunarizine dihydrochloride, and by the development code R 14950.[4] Brand names include Sibelium, Flunarin, Migon and numerous others marketed in countries across Asia, Latin America and Europe.[4] Flunarizine hydrochloride is an authorised medicine in several countries, but in the European Union clinical trial described here it is being studied as a preventive treatment for migraine.[1]
How does flunarizine hydrochloride work?
Flunarizine is a selective calcium entry blocker. It blocks the movement of calcium into cells, which can reduce the excessive electrical activity in the brain that is thought to contribute to migraine.[3] It also has calmodulin binding properties and acts as a histamine H1 receptor antagonist, meaning it blocks some of the effects of histamine in the body.[3] As a vasodilator, it widens blood vessels, which may also play a role in preventing migraine attacks.[4]
Which conditions is flunarizine hydrochloride used or studied for?
- Migraine — flunarizine is being tested to reduce the number of migraine days each month in people who need preventive treatment.[1]
- Vertigo — flunarizine is classified as an antivertigo agent, meaning it has been used for conditions involving dizziness or a spinning sensation.[4]
- Vascular disorders — as a vasodilator, flunarizine has been used in conditions where widening blood vessels may help.[4]
How is flunarizine hydrochloride given?
Flunarizine is taken by mouth. The clinical trial uses a 10 mg oral dose.[1] Pharmaceutical forms that exist for flunarizine include 5 mg capsules, 5 mg tablets, 10 mg tablets and 20 mg tablets.[2]
What do the clinical trials show?
One Phase 3 clinical trial is registered for flunarizine hydrochloride in migraine. The trial is authorised but not yet recruiting, so no results are available yet.[1] The study plans to enrol 460 participants and compares four preventive medicines: amitriptyline, flunarizine, topiramate and propranolol.[1] Flunarizine is given at a 10 mg oral dose in this study.[1]
The main thing the trial measures is clinical effectiveness, defined as the change in the mean number of monthly migraine days (MMD) after 12 weeks of treatment compared with the number before treatment started.[1] The trial is designed to find out whether flunarizine, amitriptyline or topiramate is more effective than propranolol, which is used as the comparison medicine.[1]
What side effects are known?
The sources provided for this page do not include a list of side effects for flunarizine hydrochloride.
Trials with Flunarizine hydrochloride
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