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

November 2, 2012 updated by: Nantes University Hospital

Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63009
        • Service de Neurologie A, Hôpital Gabriel Montpied-BP
      • Lille, France, 59000
        • Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille
      • Nantes, France, 44093
        • Service de Neurologie, CHU Nantes
      • Poitiers, France, 86021
        • Service de Neurologie, CHU Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with possible or probable PSP
  • from 45 to 75 year of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: valproic acid
Depakine
Drug: valproic acid
Depakine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
This score will be measured every three months during the two-year follow up of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Neuropsychological evaluation
Time Frame: inclusion, one year and two years follow up
inclusion, one year and two years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Pascal Derkinderen, Nantes university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 10, 2006

First Submitted That Met QC Criteria

October 10, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Estimate)

November 4, 2012

Last Update Submitted That Met QC Criteria

November 2, 2012

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/10-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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