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

NCT ID: NCT00385710

Last Updated: 2012-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Progressive Supranuclear Palsy

Keywords

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Progressive supranuclear palsy (PSP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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valproic acid

Depakine

Group Type EXPERIMENTAL

valproic acid

Intervention Type DRUG

Depakine

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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valproic acid

Depakine

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with possible or probable PSP
* from 45 to 75 year of age
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal Derkinderen

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Service de Neurologie A, Hôpital Gabriel Montpied-BP

Clermont-Ferrand, , France

Site Status

Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille

Lille, , France

Site Status

Service de Neurologie, CHU Nantes

Nantes, , France

Site Status

Service de Neurologie, CHU Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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05/10-H

Identifier Type: -

Identifier Source: org_study_id