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

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Brief Title

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

Official Title

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

PSPRS score (specific score for PSP)

Secondary Outcome

 Neuropsychological evaluation

Condition

Progressive Supranuclear Palsy

Intervention

valproic acid

Study Arms / Comparison Groups

 valproic acid
Description:  Depakine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

28

Start Date

November 2006

Completion Date

July 2010

Primary Completion Date

July 2010

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with possible or probable PSP

          -  from 45 to 75 year of age
      

Gender

All

Ages

45 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Pascal Derkinderen, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00385710

Organization ID

05/10-H


Responsible Party

Sponsor

Study Sponsor

Nantes University Hospital


Study Sponsor

Pascal Derkinderen, Principal Investigator, Nantes University Hospital


Verification Date

May 2011