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| Sponsor: | Nantes University Hospital |
|---|---|
| Information provided by: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00385710 |
Purpose
Progressive Supranuclear Palsy (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. The investigators 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 |
| 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 |
| Enrollment: | 28 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| France | |
| Service de Neurologie, CHU Nantes | |
| Nantes, France, 44093 | |
| Service de Neurologie, CHU Poitiers | |
| Poitiers, France, 86021 | |
| Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille | |
| Lille, France, 59000 | |
| Service de Neurologie A, Hôpital Gabriel Montpied-BP | |
| Clermont-Ferrand, France, 63009 | |
| Principal Investigator: | Pascal Derkinderen | Centre Hospitalier Universitaire de Nantes |
More Information
| Study ID Numbers: | BRD05/10-H |
| Study First Received: | October 10, 2006 |
| Last Updated: | February 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00385710 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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Progressive supranuclear palsy (PSP) |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Basal Ganglia Diseases Physiological Effects of Drugs Psychotropic Drugs Neurodegenerative Diseases Brain Diseases Valproic Acid Ocular Motility Disorders Signs and Symptoms Movement Disorders Therapeutic Uses Tranquilizing Agents Eye Diseases Nervous System Diseases |
Central Nervous System Diseases Central Nervous System Depressants Enzyme Inhibitors Ophthalmoplegia Antimanic Agents Pharmacologic Actions Paralysis Supranuclear Palsy, Progressive GABA Agents Neurologic Manifestations Cranial Nerve Diseases Tauopathies Central Nervous System Agents Anticonvulsants |