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Sponsored by: |
Nantes University Hospital |
Information provided by: | Nantes University Hospital |
ClinicalTrials.gov Identifier: | NCT00385710 |
PSP is a relentlessly progressive neurodegenerative disorder, clinically characterized by parkinsonism with prominent axial involvement and postural instability, bulbar symptoms, supranuclear ophthalmoplegia, and executive dysfunction. Abnormal neuronal and glial tau aggregations affecting the basal ganglia and selective brainstem structures result in dysfunction of the five frontosubcortical circuits and brainstem functions. There is no effective treatment for PSP. One of the key feature in the aggregation of tau is its phosphorylation by kinases such as glycogen synthase kinase 3b (GSK3b). Recent reports have shown that valproic acid was able to inhibit the activity of GSK3b and could exert a neuroprotective effect through this inhibition. We thus decided to conduct this controlled study to assess the putative neuroprotective effects in patients with PSP.
Condition | Intervention | Phase |
Progressive Supranuclear Palsy |
Drug: valproic acid |
Phase II |
Genetics Home Reference related topics: | familial paroxysmal nonkinesigenic dyskinesia |
MedlinePlus related topics: | Paralysis Progressive Supranuclear Palsy |
Drug Information available for: | Divalproex sodium Valproate Sodium Valproic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Placebo-Controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy |
Estimated Enrollment: | 36 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | June 2009 |
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Pascal Derkinderen | 00 33 (0)2 40 16 52 05 ext +33 | pascal.derkinderen@chu-nantes.fr |
France | |||||
Service de Neurologie, CHU Nantes | Recruiting | ||||
Nantes, France, 44093 | |||||
Contact: Pascal Derkinderen, PhD | |||||
Service de Neurologie, CHU Poitiers | Recruiting | ||||
Poitiers, France, 86021 | |||||
Contact: Jean-Luc Houeto, PhD | |||||
Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille | Recruiting | ||||
Lille, France, 59000 | |||||
Contact: Alexandre Kreisler, PhD | |||||
Service de Neurologie A, Hôpital Gabriel Montpied-BP | Recruiting | ||||
Clermont-Ferrand, France, 63009 | |||||
Contact: Franck Durif, PhD |
Nantes University Hospital |
Principal Investigator: | Pascal Derkinderen | Centre Hospitalier Universitaire de Nantes |
Study ID Numbers: | BRD05/10-H |
First Received: | October 10, 2006 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00385710 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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