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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00385710
First received: October 10, 2006
Last updated: November 2, 2012
Last verified: May 2011
  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
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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) [ Time Frame: This score will be measured every three months during the two-year follow up of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychological evaluation [ Time Frame: inclusion, one year and two years follow up ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: November 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: valproic acid
Depakine
Drug: valproic acid
Depakine
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385710

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

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00385710     History of Changes
Other Study ID Numbers: 05/10-H
Study First Received: October 10, 2006
Last Updated: November 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Paralysis
Supranuclear Palsy, Progressive
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
Signs and Symptoms
Tauopathies
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014