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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: Progressive Supranuclear Palsy

Treatments: Drug: Placebo; Drug: valproic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00385710

05/10-H

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

valproic acid

Experimental group

Description:

Depakine

Treatment:

Drug: valproic acid

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo