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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 Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy |
| Enrollment: | 28 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: valproic acid
Depakine
|
Drug: valproic acid
Depakine
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo
|
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 A, Hôpital Gabriel Montpied-BP | |
| Clermont-Ferrand, France, 63009 | |
| Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille | |
| Lille, France, 59000 | |
| Service de Neurologie, CHU Nantes | |
| Nantes, France, 44093 | |
| Service de Neurologie, CHU Poitiers | |
| Poitiers, France, 86021 | |
| Principal Investigator: | Pascal Derkinderen | Centre Hospitalier Universitaire de Nantes |
More Information
| Responsible Party: | University hospital (Directeur Général), Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00385710 History of Changes |
| Other Study ID Numbers: | 05/10-H |
| Study First Received: | October 10, 2006 |
| Last Updated: | May 10, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Progressive supranuclear palsy (PSP) |
|
Supranuclear Palsy, Progressive Paralysis Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Ophthalmoplegia Ocular Motility Disorders Cranial Nerve Diseases Tauopathies Neurodegenerative Diseases Neurologic Manifestations Eye Diseases Signs and Symptoms |
Valproic Acid Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |