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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

Primary Purpose

Vertigo

Status
Withdrawn
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Merislon
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertigo focused on measuring Vertigo, Posterior circulation infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 3, 2007
Last Updated
June 1, 2017
Sponsor
Eisai Inc.
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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Withdrawn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Due to poor enrollment, this study was withdrawn/ terminated.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

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