Comparison of Propranolol and Venlafaxine in Treatment of Vestibular Migraine

NCT02350985 | Completed Phase 4

• 1 other identifier: HasekiTRH
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The presented study aims to compare effectivity of propranolol with effectivity of venlafaxine in escalating dose in subjects with vestibular migraine (VM) over a period of 12 weeks. The study population consisted of subjects diagnosed definite VM according to criteria of Bárány Society and Migraine Classification Subcommittee of the International Headache Society (IHS). Effectivity of therapy was measured by Dizziness Handicap Inventory (DHI), number of vertiginous attack of last month and visual analogue scale (VAS) reported dizziness related Quality of Life (QOL). Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) were also used to determine psychiatric improvement played role in response to therapy in venlafaxine treatment arm.

Conditions

Vestibular Migraine

Keywords

Migraine; Migrainous Vertigo; Headache Disorders; Central Nervous System Origin Vertigo; Paroxysmal Vertigo; Adrenergic beta-Antagonist; Vasodilator Agent; Anti Arrhythmia Agent; Serotonin Uptake Inhibitor; Antidepressive Agent; Propranolol; Venlafaxine

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Dizziness Handicap Inventory

  4 months post randomization

Secondary Outcomes (4)

• Change from baseline in Beck Anxiety Inventory

  4 months post randomization

• Change from baseline in Beck Depression Inventory

  4 moths post randomization

• Change from baseline in dizziness related quality of life

  4 moths post randomization

• Change number of vertiginous attack

  3 moths post randomization

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

Propranolol up to 160 mg/day

Drug: Propranolol

Venlafaxine

ACTIVE COMPARATOR

Venlafaxine up to 150 mg/day

Drug: Venlafaxine

Interventions

Propranolol DRUG

Propranolol was given in a flexible dose between 40 mg to 160 mg with an escalating fashion starting at 40 mg PO AM for one week and followed by 40 mg AM and 40 mg PM for a total dose up to 160 mg daily

Also known as: Dideral

Propranolol

Venlafaxine DRUG

Venlafaxine treatment was followed as: 37.5 mg qhs for two weeks and followed 75 mg qhs with an escalating dose with 2 weeks periods up to 150 mg daily

Also known as: Efexor

Venlafaxine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• vestibular migraine does not respond lifestyle and dietary modification

You may not qualify if:

• known allergic reaction to venlafaxine or propranolol
• under the care of psychiatrist
• pregnancy or intention to become pregnant
• presence significant illness or medical condition such as cancer, liver or kidney failure
• certain medical conditions with possible adverse effects with propranolol or venlafaxine following as: AV block or bradyarrhythmia; astma or COPD; diabetes mellitus.

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, 34096, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders; Vertigo

Interventions

Propranolol; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending ENT surgeon

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: January 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 30, 2015

Record last verified: 2015-01

Locations

TU (1)