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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
History of Changes
  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:

U.S. FDA Resources

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

Locations
China, Beijing
Beijing Tiantan Hospital
Beijing, Beijing, China, 100050
Beijing Hospital
Beijing, Beijing, China, 100730
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
Stroke
Infarction
Vertigo
Dizziness
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
 Pathologic Processes
Necrosis
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Signs and Symptoms
Sensation Disorders
Betahistine
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013