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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00385710
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : November 5, 2012
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Drug: valproic acid Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy
Study Start Date : November 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: valproic acid
Drug: valproic acid
Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. 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 :
  1. Neuropsychological evaluation [ Time Frame: inclusion, one year and two years follow up ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Nantes University Hospital Identifier: NCT00385710     History of Changes
Other Study ID Numbers: 05/10-H
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: November 5, 2012
Last Verified: May 2011

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