Corticosteroids in Prevention of Facial Palsy After Cranial Base Surgery

This study is currently recruiting participants.

Verified by Assistance Publique - Hôpitaux de Paris, September 2007

First Received: February 9, 2007 Last Updated: April 25, 2008 History of Changes

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:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Benign Tumors Paralysis Surgery

Drug Information available for: 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 ]

Estimated Enrollment:	380
Study Start Date:	March 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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

Show Detailed Description

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

Contacts

Contact: Alexis BOZORG GRAYELI, MD,PhD

+33 (0)-1 40 87 56 29

alexis.bozorg-grayeli@bjn.aphp.fr

Locations

France
Assistance Publique Hopitaux De Paris	Recruiting
CLICHY, France
Contact: Alexis BOZORG GRAYELLI, MD,PhD +33(0)- 1 40 87 56 29 alexis.bozorg-grayeli@bjn.aphp.fr

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:	Department Clinical Research of Developpement ( Cécile KEDZIA )
Study ID Numbers:	P051072
Study First Received:	February 9, 2007
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00438087 History of Changes
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:

Mouth Diseases
Anti-Inflammatory Agents
Disease Attributes
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Signs and Symptoms
Pathologic Processes
Therapeutic Uses
Methylprednisolone Hemisuccinate

Antineoplastic Agents, Hormonal
Facies
Bell Palsy
Nervous System Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Glucocorticoids
Protective Agents
Facial Paralysis
Pharmacologic Actions
Herpesviridae Infections
Paralysis
Virus Diseases
Autonomic Agents
Facial Nerve Diseases

ClinicalTrials.gov processed this record on November 25, 2009