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Completed

NCT Number: NCT00385710

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

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.

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Key information

Conditions

Progressive Supranuclear Palsy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Supranuclear Palsy, Progressive Tauopathies

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Valproic acid

Drug

Depakine

Placebo

Drug

Placebo

Primary outcomes

  1. PSPRS score (specific score for PSP)

    Time frame: This score will be measured every three months during the two-year follow up of the study

Secondary outcomes

  1. Neuropsychological evaluation

    Time frame: inclusion, one year and two years follow up

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 11, 2006
Registry last updated
Nov 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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