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

NCT00385710 | Completed Phase 2

• 1 other identifier: 05/10-H
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

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.

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive supranuclear palsy (PSP)

Outcome Measures

Primary Outcomes (1)

• PSPRS score (specific score for PSP)

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

Secondary Outcomes (1)

• Neuropsychological evaluation

  inclusion, one year and two years follow up

Study Arms (2)

valproic acid

EXPERIMENTAL

Depakine

Drug: valproic acid

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

valproic acid DRUG

Depakine

valproic acid

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (4)

Service de Neurologie A, Hôpital Gabriel Montpied-BP

Clermont-Ferrand, 63009, France

Location

Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille

Lille, 59000, France

Location

Service de Neurologie, CHU Nantes

Nantes, 44093, France

Location

Service de Neurologie, CHU Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Pascal Derkinderen

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 11, 2006
• Study Start: November 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 5, 2012

Record last verified: 2011-05

Locations

FR (4)