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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00385710
Enrollment
28
Registered
2006-10-11
Start date
2006-11-01
Completion date
2010-07-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive supranuclear palsy (PSP)

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.

Interventions

DRUGvalproic acid

Depakine

DRUGPlacebo

Placebo

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Neuropsychological evaluationinclusion, one year and two years follow up

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPascal Derkinderen

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026