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

Phase 2

Completed

• Conditions: Progressive Supranuclear Palsy
• Interventions: Drug: valproic acid; Drug: Placebo

• Registration Number: NCT00385710
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Study Start: 2006-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-05
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
valproic acid	valproic acid	Depakine
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
PSPRS score (specific score for PSP)	This score will be measured every three months during the two-year follow up of the study

Secondary Outcome Measures

Name	Time	Method
Neuropsychological evaluation	inclusion, one year and two years follow up

Trial Locations

Locations (4)

Service de Neurologie A, Hôpital Gabriel Montpied-BP; 🇫🇷 Clermont-Ferrand, France

Service de Neurologie, CHU Nantes; 🇫🇷 Nantes, France

Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille; 🇫🇷 Lille, France

Service de Neurologie, CHU Poitiers; 🇫🇷 Poitiers, France