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

Progressive Supranuclear Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385710
• Other study ID #: 05/10-H
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2006
• Last updated: November 2, 2012
• Start date: November 2006
• Est. completion date: July 2010

Study information

• Verified date: May 2011
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with possible or probable PSP

• from 45 to 75 year of age

Study Design

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

Related Conditions & MeSH terms

• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Drug:
• valproic acid
Depakine
• Placebo
Placebo

Locations

Country	Name	City	State
France	Service de Neurologie A, Hôpital Gabriel Montpied-BP	Clermont-Ferrand
France	Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille	Lille
France	Service de Neurologie, CHU Nantes	Nantes
France	Service de Neurologie, CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSPRS score (specific score for PSP)		This score will be measured every three months during the two-year follow up of the study	No
Secondary	Neuropsychological evaluation		inclusion, one year and two years follow up	No