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