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

Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Progressive Supranuclear Palsy

Intervention: valproic acid (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Nantes University Hospital

Official(s) and/or principal investigator(s):
Pascal Derkinderen, Principal Investigator, Affiliation: Nantes University Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: PSPRS score (specific score for PSP)

Secondary outcome: Neuropsychological evaluation

Eligibility

Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with possible or probable PSP

- from 45 to 75 year of age

Locations and Contacts

Service de Neurologie A, Hôpital Gabriel Montpied-BP, Clermont-Ferrand 63009, France

Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille, Lille 59000, France

Service de Neurologie, CHU Nantes, Nantes 44093, France

Service de Neurologie, CHU Poitiers, Poitiers 86021, France

Additional Information

Starting date: November 2006
Last updated: November 2, 2012

Page last updated: August 20, 2015

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