Back to resultsA Study To Evaluate The Efficacy And Safety Of Betahistine Mesilate In The Treatment Of Patients With Vertigo Caused By Cerebral Infarction In Posterior Circulation
Primary Purpose
Vertigo
Status
Withdrawn
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Merislon
Sponsored by
About this trial
This is an interventional treatment trial for Vertigo focused on measuring Vertigo, Posterior circulation infarction
Eligibility Criteria
Inclusion Criteria:
1. Patients that have a clinical diagnosis of posterior circulation infarction and vertigo occurring within 1 month after the infarction.
Sites / Locations
- Beijing Tiantan Hospital
- Beijing Hospital
- Shanghai Renji Hospital
- Shanghai Huashan Hospital
Outcomes
Primary Outcome Measures
Changes in the European Evaluation of Vertigo (EEV) scale in 4 weeks.
Secondary Outcome Measures
The duration of the vertigo symptom.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00474409
Brief Title
A Study To Evaluate The Efficacy And Safety Of Betahistine Mesilate In The Treatment Of Patients With Vertigo Caused By Cerebral Infarction In Posterior Circulation
Official Title
A Multicenter, Placebo-Controlled, Double-Blind Study To Evaluate The Efficacy And Safety Of Betahistine Mesilate In The Treatment Of Patients With Vertigo Caused By Cerebral Infarction In Posterior Circulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Due to poor enrollment, this study was withdrawn/ terminated.
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy and safety of Betahistine Mesilate in the treatment of patients with vertigo caused by Cerebral Infarction in posterior circulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo
Keywords
Vertigo, Posterior circulation infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Merislon
Primary Outcome Measure Information:
Title
Changes in the European Evaluation of Vertigo (EEV) scale in 4 weeks.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The duration of the vertigo symptom.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Patients that have a clinical diagnosis of posterior circulation infarction and vertigo occurring within 1 month after the infarction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Yong Jun
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Shanghai Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20001
Country
China
Facility Name
Shanghai Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study To Evaluate The Efficacy And Safety Of Betahistine Mesilate In The Treatment Of Patients With Vertigo Caused By Cerebral Infarction In Posterior Circulation
We'll reach out to this number within 24 hrs