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Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy
This study is ongoing, but not recruiting participants.
First Received: October 10, 2006   Last Updated: February 24, 2009   History of Changes
Sponsor: Nantes University Hospital
Information provided by: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00385710
  Purpose

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.


Condition Intervention Phase
Progressive Supranuclear Palsy
Drug: valproic acid
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Randomized Placebo-Controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • PSPRS score (specific score for PSP)This score will be measured every three months during the two-year follow up of the study [ Time Frame: This score will be measured every three months during the two-year follow up of the study ]

Secondary Outcome Measures:
  • Neuropsychological evaluation [ Time Frame: inclusion, one year and two years follow up ]

Enrollment: 28
Study Start Date: November 2006
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with possible or probable PSP
  • from 45 to 75 year of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385710

Locations
France
Service de Neurologie, CHU Nantes
Nantes, France, 44093
Service de Neurologie, CHU Poitiers
Poitiers, France, 86021
Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille
Lille, France, 59000
Service de Neurologie A, Hôpital Gabriel Montpied-BP
Clermont-Ferrand, France, 63009
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Pascal Derkinderen Centre Hospitalier Universitaire de Nantes
  More Information

No publications provided

Study ID Numbers: BRD05/10-H
Study First Received: October 10, 2006
Last Updated: February 24, 2009
ClinicalTrials.gov Identifier: NCT00385710     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:
Progressive supranuclear palsy (PSP)

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Basal Ganglia Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Neurodegenerative Diseases
Brain Diseases
Valproic Acid
Ocular Motility Disorders
Signs and Symptoms
Movement Disorders
Therapeutic Uses
Tranquilizing Agents
Eye Diseases
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Depressants
Enzyme Inhibitors
Ophthalmoplegia
Antimanic Agents
Pharmacologic Actions
Paralysis
Supranuclear Palsy, Progressive
GABA Agents
Neurologic Manifestations
Cranial Nerve Diseases
Tauopathies
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 20, 2009