|
|
|
|
|
|
Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00438087 |
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 |
Genetics Home Reference related topics: | neurofibromatosis type 2 |
MedlinePlus related topics: | Bell's Palsy Benign Tumors Paralysis |
ChemIDplus related topics: | Methylprednisolone Corticosteroids |
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 |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexis BOZORG GRAYELI, MD,PhD | +33 (0)-1 40 87 56 29 | alexis.bozorg-grayeli@bjn.aphp.fr |
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 |
Assistance Publique - Hôpitaux de Paris |
Principal Investigator: | Alexis BOZORG GRAYELI, MD,PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Cécile KEDZIA ) |
Study ID Numbers: | P051072 |
First Received: | February 9, 2007 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00438087 |
Health Authority: | France: Ministry of Health |
|
|
|
|
|