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Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine)

This study has been completed.
Information provided by (Responsible Party):
Nantes University Hospital Identifier:
First received: October 10, 2006
Last updated: November 2, 2012
Last verified: May 2011
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy

Resource links provided by NLM:

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • PSPRS score (specific score for PSP) [ Time Frame: This score will be measured every three months during the two-year follow up of the study ]

Secondary Outcome Measures:
  • Neuropsychological evaluation [ Time Frame: inclusion, one year and two years follow up ]

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
Drug: valproic acid
Placebo Comparator: Placebo
Drug: Placebo


Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with possible or probable PSP
  • from 45 to 75 year of age
  Contacts and Locations
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Please refer to this study by its identifier: NCT00385710

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
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: Pascal Derkinderen Nantes University Hospital
  More Information

Responsible Party: Nantes University Hospital Identifier: NCT00385710     History of Changes
Other Study ID Numbers: 05/10-H
Study First Received: October 10, 2006
Last Updated: November 2, 2012

Keywords provided by Nantes University Hospital:
Progressive supranuclear palsy (PSP)

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Neurodegenerative Diseases
Eye Diseases
Valproic Acid
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 processed this record on April 26, 2017