Progressive Supranuclear PalsyPhase 2NCT00385710
Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine)
A Phase 2 study testing valproic acid in people with Progressive Supranuclear Palsy, run by Nantes University Hospital at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Progressive Supranuclear Palsy
- What is being tested?
- valproic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2006to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with possible or probable PSP
- from 45 to 75 year of age
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de Neurologie A, Hôpital Gabriel Montpied-BP
Clermont-Ferrand, 63009
Service de Neurologie et Pathologie du mouvement Hôpital Roger Salingro, CHRU de Lille
Lille, 59000
Service de Neurologie, CHU Nantes
Nantes, 44093
Service de Neurologie, CHU Poitiers
Poitiers, 86021
About this study
Official title: Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy
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
- Being tested
- valproic acid, Placebo
- Keywords
- Progressive supranuclear palsy (PSP)
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valproic acidDrug
Depakine
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| valproic acid | Experimental | Depakine Receives: Drug: valproic acid |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSPRS score (specific score for PSP)
Measured: This score will be measured every three months during the two-year follow up of the study
Secondary outcomes (1)
Neuropsychological evaluation
Measured: inclusion, one year and two years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Derkinderen, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385710
- Sponsor's protocol ID
- BRD/05/10-H
- Status last verified
- May 2011
- First submitted
- 10 Oct 2006
- Last updated
- 14 Sep 2026
- Results posted
- No
Publications
Leclair-Visonneau L, Rouaud T, Debilly B, Durif F, Houeto JL, Kreisler A, Defebvre L, Lamy E, Volteau C, Nguyen JM, Dily SL, Damier P, Boutoleau-Bretonniere C, Lejeune P, Derkinderen P. Randomized placebo-controlled trial of sodium valproate in progressive supranuclear palsy. Clin Neurol Neurosurg. 2016 Jul;146:35-9. doi: 10.1016/j.clineuro.2016.04.021. Epub 2016 Apr 27.
PubMed 27136096
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy
- ClinicalTrials.gov ID
- NCT00385710
- Acronym / sponsor ID
- BRD/05/10-H
- Conditions
- Progressive Supranuclear Palsy
- Keywords
- Progressive supranuclear palsy (PSP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| valproic acid | Experimental | Drug: valproic acidDepakine |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with possible or probable PSP
- from 45 to 75 year of age
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valproic acidDepakine | Drug | valproic acid |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Neuropsychological evaluation
Time frame: inclusion, one year and two years follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 27136096Leclair-Visonneau L, Rouaud T, Debilly B, Durif F, Houeto JL, Kreisler A, Defebvre L, Lamy E, Volteau C, Nguyen JM, Dily SL, Damier P, Boutoleau-Bretonniere C, Lejeune P, Derkinderen P. Randomized placebo-controlled trial of sodium valproate in progressive supranuclear palsy. Clin Neurol Neurosurg. 2016 Jul;146:35-9. doi: 10.1016/j.clineuro.2016.04.021. Epub 2016 Apr 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Derkinderen principal investigator
Nantes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing valproic acid in people with Progressive Supranuclear Palsy, run by Nantes University Hospital at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00385710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.