Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909600414183 Date of Approval: 30/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between the Efficiency of Cinnarizine and Topiramate in the treatment of Vestibular Migraine
Official scientific title Comparison between the Efficiency of Cinnarizine and Topiramate in the treatment of Vestibular Migraine
Brief summary describing the background and objectives of the trial 1- Study the effectiveness of cinnarizine and topiramate as prophylactic therapy for vestibular migraine. 2- Compare the efficiency of both drugs.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2018
Actual trial start date 01/01/2018
Anticipated date of last follow up 01/08/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group cinnarizine cinnarizine 25mg/8 hours 3 months • Subjects included in this study will be divided into 2 groups: Patients treated with Cinnarizine (group A): It will consist of 36 cases. Patients treated with Topiramate (group B): It will consist of 36 cases. 36 Uncontrolled
Experimental Group topiramate 50mg/d 3 months *Topiramate treatment regimen : 50 mg PO daily 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A. At least five episodes with vestibular symptoms of moderate or severe intensity, each lasting 5 min to 72 h B. Current or previous history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD) C. One or more migraine features with at least 50% of the vestibular episodes: • Headache with at least two of the following characteristics: one-sided location, pulsating quality, moderate or severe pain intensity, or aggravation by routine physical activity • Photophobia and phonophobia • Visual aura D. Not better accounted for by another vestibular or ICHD diagnosis. age more than 60 years age less than 18 years Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/02/2018 values and ethics committee faculty of medicine menoufya university
Ethics Committee Address
Street address City Postal code Country
Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of medicine shbein elkoum 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the change in monthly frequency of vertigo attacks and migraine attacks during the study , duration of attacks 2 weeks, 1 month and 3 months after treatment
Secondary Outcome The cost of the therapy and incidence of side effects assessed 2 weeks, 1 month and 3 months after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menoufiya university hospital shbein elkoum shbein elkoum Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Menoufia University yaseen abd elghaffar shbein elkom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine menoufya university Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of medicine shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Hossam Sanyelbhaa Port-Said Port Said Egypt
Prof. Dr. Abd ElLatif Ibrahim El Rashidy Tanta tanta Egypt
Prof. Dr. Abd El Mageed Hasan Qabel Cairo Cairo Egypt
Prof. Dr. Asmaa Salah Mokhtar Shbein Elkom Shbien Elkom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hossam sanyelbahaa Sanyelbhaa@yahoo.com 00201220689172 PortSaid
City Postal code Country Position/Affiliation
PortSaid Egypt professor of audiology
Role Name Email Phone Street address
Scientific Enquiries asmaa salah asmaa82@yahoo.com 00201002056491 shiben elkom
City Postal code Country Position/Affiliation
shiben elkom Egypt audiology lecturer
Role Name Email Phone Street address
Public Enquiries nancy omran doctornana2012@gmail.com 00201007270804 19 youssef st. shbien elkom menoufia
City Postal code Country Position/Affiliation
shbein elkom Egypt audiology resident
Role Name Email Phone Street address
Principal Investigator nancy omran doctornana2012@gmail.com 00201007270804 shbein el kom
City Postal code Country Position/Affiliation
shbein elkom Egypt audiology resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Patients with Vestibular migraine ranging from 18-60 years old Age, sex, treatment, vertigo: duration & frequency of attack basic , 2wks, 1,2,3 months after ttt , , duration of headache , duration of attack of headache , basic, 2 wks, 1,2,3 months after ttt, frequency of attack of headache , basic, 2 wks, 1,2,3 months after ttt, side effects Study Protocol start date of the trial 1/1/2018 IPD is available Controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information