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.

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 Betahistine dihydrochloride

U.S. FDA Resources

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

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

Keywords provided by Eisai Medical Research Inc.:

Vertigo
Posterior circulation infarction

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Betahistine
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:

Neurotransmitter Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Histamine Agents
Cardiovascular Agents

Pharmacologic Actions
Pathologic Processes
Histamine Agonists
Therapeutic Uses
Cardiovascular Diseases
Labyrinth Diseases

ClinicalTrials.gov processed this record on January 16, 2009