Comparison of the effect of using rizatriptan with Betahistine in the treatment of the acute phase of vertigo in outpatients with vestibular migraine referred to a private clinic.
Design
A double blinded parallel group phase 3 clinical trial with 40 patients randomized with www.Randomization.com site.
Settings and conduct
The present study will be a clinical trial designed to compare the effectiveness of rizatriptan and Betahistine in the treatment of vertigo in patients with vestibular migraine in its acute phase. About 40 patients with a history of vestibular migraine who present with vertigo to a private neurology or otolaryngology clinic will be selected based on the diagnostic criteria of vestibular migraine of the International Headache Society and entered the study randomly based on the inclusion and exclusion criteria. And will be divided into two groups A (the group receiving rizatriptan oral 10 mg ) and group B( receiving Betahistine 8 mg) and will be evaluated and compared after two hours and 24 hours after receiving the drugs, respectively, in terms of the severity of dizziness and the response rate to the treatment.
Participants/Inclusion and exclusion criteria
Including the criteria of the International Headache Society for vestibular migraine; presence of acute vertigo with moderate to severe intensity at the time of visit, age 18 to 6. Exclusion criteria: History of basilar or hemiplegic migraine: presence of severe kidney and liver disorders; symptoms suggestive of ischemic heart disease or history of cardiovascular diseases and history of stroke or TIA; systolic blood pressure above 160 or diastolic blood pressure above 90; pregnancy; Lack of consent to participate in the study
Intervention groups
Group A (receiving oral rizatriptan 10 mg) and group B (group receiving Betahistine 8 mg)
Main outcome variables
Dizziness severity, Response rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230913059428N1
Registration date:2023-10-09, 1402/07/17
Registration timing:prospective
Last update:2023-10-09, 1402/07/17
Update count:0
Registration date
2023-10-09, 1402/07/17
Registrant information
Name
Venus Ghaffarzadeh Farid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3658 2544
Email address
v.ghaffarzadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of sublingual Rizatriptan versus oral Betahistin in acute phase treatment of vertigo in patients suffering from vestibular migraine
Public title
Rizatriptan versus Betahistin in Vestibular Migraine treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Including the International Headache Society criteria for vestibular migraine
Acute vertigo with moderate to severe intensity
Exclusion criteria:
Patients with suspected vestibular disorders other than vestibular migraine
Patients with a suspected history of Orthostatic Hypotension or panic disorders
history of basilar or hemiplegic migraine
Presence of severe kidney or liver disorders
Symptoms suggestive of ischemic heart disease
history of HTN
history of previous TIA/stoke
history of drug or substance or alcohol abuse
Systolic blood pressure above 160 or diastolic blood pressure above 90
pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The samples eligible for study will be randomly assigned to two treatment groups with oral rizatriptan or Betahistine treatment using www.Randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the patients and all the researchers (ear, nose and throat specialist, neurologist, neurology resident, statistical consultant) will be unaware of the patient's exposure (Betahistine or Rrizatriptan).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working group/committee of ethics in research of Tabriz University of Medical Sciences
Street address
No.74,Dastmalchi Alley., Abbasi Ave., , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155734831
Approval date
2023-10-07, 1402/07/15
Ethics committee reference number
IR.TBZMED.REC.1402.510
Health conditions studied
1
Description of health condition studied
vestibular migraine
ICD-10 code
G43
ICD-10 code description
Migraine
2
Description of health condition studied
vestibular migraine
ICD-10 code
H81.8X
ICD-10 code description
Other disorders of vestibular function
Primary outcomes
1
Description
dizziness intensity
Timepoint
At the beginning of the study (before the start of the intervention) and 4 and 24 hours after taking the drug
Method of measurement
Compiled questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: (The first intervention group) patients in this group will receive oral rizatriptan 10 mg (Farabi Pharmaceuticals) once as a stat dose.
Category
Treatment - Drugs
2
Description
Intervention group: (second intervention group): Patients of this group will receive oral Betahistine 8 mg (Actoverco Pharmaceuticals) once as a stat dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Aban Otolaryngology Clinic
Full name of responsible person
venus Ghaffarzadeh Farid
Street address
No.74,. Dastmalchi Alley, Abbasi Ave., before Tavanir Blvdabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155831734
Phone
+98 914 100 7754
Email
v.ghaffarzadeh@tbzdmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Venus Ghaffarzadeh Farid
Street address
No.74,. Dastmalchi Alley, Abbasi Ave., before Tavanir Blvdabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155831734
Phone
+98 914 100 7754
Email
v.ghaffarzadeh@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Venus Ghaffarzadeh Farid
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
No.74,Dastmalchi Alley., Abbasi Ave., , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155831734
Phone
+98 41 3658 2544
Email
v.ghaffarzadeh@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Venus Ghaffarzadeh Farid
Position
Neurology resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
No.74,Dastmalchi Alley., Abbasi Ave., , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155831734
Phone
+98 41 3658 2544
Email
v.ghaffarzadeh@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Venus Ghaffarzadeh Farid
Position
Neurology resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
No.74, Abbasi St., Before Tavanir Bvd,. Dastmalchi alley, East 8 meter
City
Tabriz
Province
East Azarbaijan
Postal code
5155831734
Phone
+98 41 3658 2544
Email
v.ghaffarzadeh@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available