Corticosteroids in Prevention of Facial Palsy After Cranial Base Surgery - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00438087

Purpose

Facial palsy after surgical removal of cranial base tumors adherent to the nerve can partly be explained by inflammation.

Condition	Intervention	Phase
Facial Palsy	Drug: methylprednisolone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Assessment of Corticosteroid Effect in the Prevention of Facial Palsy After Cerebella-pontine Angle Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: neurofibromatosis type 2

MedlinePlus related topics: Bell's Palsy Cancer Paralysis

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone Corticosteroids

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Assessment of the facial function at 8 days postoperative [ Time Frame: at 8 days postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assessment of the facial function at 1 day postoperative [ Time Frame: at 1 day postoperative ] [ Designated as safety issue: Yes ]

Enrollment:	380
Study Start Date:	March 2007
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 2 placebo versus methylprednisolone	Drug: methylprednisolone methylprednisolone administrated intra and post operatively Other Name: methylprednisolone administrated intra and post operatively
Experimental: 1 placebo versus methylprednisolone	Drug: methylprednisolone methylprednisolone administrated intra and post operatively Other Name: methylprednisolone administrated intra and post operatively

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adults patients
surgery of base crane tumors
accept to participate
having health insurance

Exclusion Criteria:

pregnant woman
children
known allergy to steroids
preoperative facial palsy of grade >2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438087

Locations

France
Assistance Publique Hopitaux de Paris
Clichy, France

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Alexis BOZORG GRAYELI, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Cécile KEDZIA, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier:	NCT00438087 History of Changes
Other Study ID Numbers:	P051072
Study First Received:	February 9, 2007
Last Updated:	March 25, 2011
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Facial palsy
Vestibular schwannoma
Anti-inflammatory drugs
Post surgery of vestibular schwannoma
or of cranial base tumors

Additional relevant MeSH terms:

Facies
Facial Paralysis
Bell Palsy
Paralysis
Disease Attributes
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases

Cranial Nerve Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012