NCT00438087

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

3 years

First QC Date

February 9, 2007

Last Update Submit

July 6, 2012

Conditions

Facial Palsy

Keywords

Facial palsyVestibular schwannomaAnti-inflammatory drugsPost surgery of vestibular schwannomaor of cranial base tumors

Outcome Measures

Primary Outcomes (1)

  • Assessment of the facial function at 8 days postoperative

    at 8 days postoperative

Secondary Outcomes (1)

  • Assessment of the facial function at 1 day postoperative

    at 1 day postoperative

Study Arms (2)

2

PLACEBO COMPARATOR

placebo versus methylprednisolone

Drug: methylprednisolone

1

EXPERIMENTAL

placebo versus methylprednisolone

Drug: methylprednisolone

Interventions

methylprednisoloneDRUG

methylprednisolone administrated intra and post operatively

Also known as: methylprednisolone administrated intra and post operatively
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Paris

Clichy, France

Location

MeSH Terms

Conditions

Facial ParalysisNeuroma, Acoustic

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Alexis BOZORG GRAYELI, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 21, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2010

Study Completion

January 1, 2011

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

FR(1)