Comparison of Propranolol and Venlafaxine in Treatment of Vestibular Migraine
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|ClinicalTrials.gov Identifier: NCT02350985|
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : January 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Migraine||Drug: Propranolol Drug: Venlafaxine||Phase 4|
Vestibular migraine (VM) is a condition of episodic vertigo linked to migrainous symptoms described by Nueuhauser et al. in 2001. Some subjects benefit behavior and diet modification and controls of their symptoms. Anti-migrainous medication for prophylactic aim is given subjects who do not benefit life-style improvement. However, there is absence of sufficient evidence for treatment of VM.
In this study the investigators aimed to evaluated effectiveness of prophylactic treatment venlafaxine by comparing propranolol in VM. The investigators also aimed to investigate if the effectiveness of venlafaxine is linked to the improvement of psychiatric condition.
All subjects who were suspected to having VM referred to both M.S. (Department of Otolaryngology) and H.A. (Department of Neurology) in order to ensure subjects fill the criteria of VM and did not have other vestibular disorders. All subjects underwent detailed neurologic, neurotologic examination, audiometric investigation, videonystagmography (VNG) and bithermal caloric testing in order to exclude other or additional vestibular or neurologic disease. Subjects who were18 years or old with a history of (at least 2 months) definite VM according to criteria of Bárány Society and Migraine Classification Subcommittee of the International Headache Society (IHS) were eligible for this study. After a subject fill the eligibility criteria of the study who did not respond to lifestyle or dietary modification were enrolled to the study.
Subjects were enrolled to the study if they filled to the inclusion and exclusion criteria and written informed consent was obtained from all subjects. Subjects were randomized using sealed envelop methods by A.K. (Department of Otolaryngology). Before starting intervention protocol 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 obtained from all subjects by T.Y. (Department of Otolaryngology). Subjects were given propranolol or venlafaxine treatment according to randomization with balanced allocation (1:1). The study was unblinded because the study is not an investigational and propranolol was paid by government health insurance. However, venlafaxine is not paid for the migraine therapy by government health insurance and venlafaxine was provided by Institution Research Funding System.
The intervention protocol was carried on by T.Y. under supervision of H.A and M.S.. 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. 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. All participants were asked to self-titrate their medication in case if inform the researchers. Subjects were to be seen at the clinic biweekly for first month in order to evaluated adverse effects and to make sure participants were having sufficient dosage. The effective duration of the treatment was considered as 3 months and participants were asked to continue using their medication one more month in order to evaluate change from baseline to 3rd month in terms of number of vertiginous attacks of the last month. All participants were assessed at the clinic at month 1, 3 and 4. Change from baseline DHI, VAS, BAI and BDI were scored at 4th month.
Adverse effects, reason to exclude the subjects from the study, reason subjects refused to continue the study and other reasons subjects could not follow the protocol were all recorded during clinic visits or obtained over the phone at home.
The analysis primary endpoint was performed following the intention-to-treat (ITT) method. Missing data was handled by multiple imputation method.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectivity of Propranolol and Venlafaxine in Treatment of Vestibular Migraine: A Randomized Controlled Clinical Trial|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Propranolol
Propranolol up to 160 mg/day
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
Other Name: Dideral
Active Comparator: Venlafaxine
Venlafaxine up to 150 mg/day
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
Other Name: Efexor
- Change from baseline in Dizziness Handicap Inventory [ Time Frame: 4 months post randomization ]
- Change from baseline in Beck Anxiety Inventory [ Time Frame: 4 months post randomization ]
- Change from baseline in Beck Depression Inventory [ Time Frame: 4 moths post randomization ]
- Change from baseline in dizziness related quality of life [ Time Frame: 4 moths post randomization ]Dizziness related quality of life score by visual analog scale
- Change number of vertiginous attack [ Time Frame: 3 moths post randomization ]Baseline of number of attacks were obtained 1 moths before randomization and months between 3 and 4 moths after randomization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350985
|Haseki Training and Research Hospital|
|Istanbul, Turkey, 34096|