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Corticosteroids in Prevention of Facial Palsy After Cranial Base Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00438087
First received: February 9, 2007
Last updated: July 6, 2012
Last verified: July 2012
History of Changes
  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 3

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:

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: 313
Study Start Date: March 2007
Study Completion Date: January 2011
Primary Completion Date: March 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

  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

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: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00438087     History of Changes
Other Study ID Numbers: P051072
Study First Received: February 9, 2007
Last Updated: July 6, 2012
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 hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013