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

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study Identification, Study Status, Referencesv7
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Notable Primary endpoint revised Trial status: Active, Not Recruiting to Completed · Primary and study completion dates changed from estimate of Aug 2010 to Jul 2010 · Interventions: valproic acid (Drug) to Placebo (Drug), valproic acid (Drug) · 2 morev5 Show 5 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Aug 2010 to Jul 2010
    • Interventions: valproic acid (Drug) to Placebo (Drug), valproic acid (Drug)
    • Study arms: 0 to 2
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 36 to confirmed 28 · Primary completion date: Aug 2010 · Completion date: Jun 2009 to Aug 2010 · 4 morev4 Show 7 more changesShow less
    • Enrollment target: estimated 36 to confirmed 28
    • Primary completion date: Aug 2010
    • Completion date: Jun 2009 to Aug 2010
    • Eligibility criteria revised
    • Secondary endpoint revised
    • Site details revised at 4 of 4 sites
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Minor Study Status, Conditions, Eligibilityv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date: Oct 2006 to Nov 2006v2 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date: Oct 2006 to Nov 2006
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00385710
Lead Sponsor Nantes University Hospital
Conditions Progressive Supranuclear Palsy
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov