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. )

First Received: May 3, 2007 Last Updated: December 5, 2008 History of Changes

Sponsored by:	Eisai China Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00474409

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 IV

MedlinePlus related topics: Dizziness and Vertigo

Drug Information available for: Betahistine dihydrochloride Betahistine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Active Control, Double Blind (Subject, Investigator), Parallel Assignment, Randomized, Safety/Efficacy Study, 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

Further study details as provided by Eisai Medical Research 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 Tiantan Hospital
Beijing, China, 100050
Beijing Hospital
Beijing, China, 100730
Shanghai Huashan Hospital
Shanghai, China, 200040
Shanghai Renji Hospital
Shanghai, China, 20001

Sponsors and Collaborators

Eisai China Inc.

Investigators

Principal Investigator:

Wang Yong Jun

Beijing Tiantan Hospital

More Information

No publications provided

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

Keywords provided by Eisai Medical Research Inc.:

Posterior circulation infarction
Vertigo

Study placed in the following topic categories:

Vasodilator Agents
Neurotransmitter Agents
Otorhinolaryngologic Diseases
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Betahistine
Cardiovascular Agents
Ischemia
Vestibular Diseases
Brain Diseases

Ear Diseases
Cerebrovascular Disorders
Vertigo
Histamine
Signs and Symptoms
Necrosis
Histamine phosphate
Neurologic Manifestations
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Physiological Effects of Drugs
Betahistine
Vestibular Diseases
Brain Diseases
Cerebrovascular Disorders
Ear Diseases
Vertigo
Signs and Symptoms
Necrosis
Pathologic Processes
Therapeutic Uses

Brain Ischemia
Cardiovascular Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Histamine Agents
Cardiovascular Agents
Ischemia
Pharmacologic Actions
Histamine Agonists
Neurologic Manifestations
Brain Infarction
Infarction

ClinicalTrials.gov processed this record on March 16, 2009