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| Sponsored by: |
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 |
| 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 |
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2: Placebo Comparator
placebo versus methylprednisolone
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Drug: methylprednisolone
methylprednisolone administrated intra and post operatively
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1: Experimental
placebo versus methylprednisolone
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Drug: methylprednisolone
methylprednisolone administrated intra and post operatively
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 |
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