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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

This study has been terminated.
(Due to poor enrollment, this study was terminated.)
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00474409
First received: May 3, 2007
Last updated: December 5, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Vertigo
Drug: Merislon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Changes in the European Evaluation of Vertigo (EEV) scale in 4 weeks. [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • The duration of the vertigo symptom.

Estimated Enrollment: 360
Study Start Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Patients that have a clinical diagnosis of posterior circulation infarction and vertigo occurring within 1 month after the infarction.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474409

Locations
China, Beijing
Beijing Hospital
Beijing, Beijing, China, 100730
Beijing Tiantan Hospital
Beijing, Beijing, China, 100050
China, Shanghai
Shanghai Huashan Hospital
Shanghai, Shanghai, China, 200040
Shanghai Renji Hospital
Shanghai, Shanghai, China, 20001
Sponsors and Collaborators
Eisai China Inc.
Investigators
Principal Investigator: Wang Yong Jun Beijing Tiantan Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00474409     History of Changes
Other Study ID Numbers: MRS-CHN-001
Study First Received: May 3, 2007
Last Updated: December 5, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Eisai Inc.:
Vertigo
Posterior circulation infarction

Additional relevant MeSH terms:
Vestibular Diseases
Cerebral Infarction
Dizziness
Infarction
Stroke
Vertigo
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ear Diseases
Ischemia
Labyrinth Diseases
Necrosis
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Pathologic Processes
Sensation Disorders
Signs and Symptoms
Vascular Diseases
Betahistine
Cardiovascular Agents
Histamine Agents
Histamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014