Supranuclear Palsy, ProgressivePhase 2NCT00139373
Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy
A Phase 2 study testing donepezil in people with Supranuclear Palsy, Progressive, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
The syndrome of distractibility is a behavioral disorder induced by a lesion or a dysfunction of the frontal lobe. This sign is frequent in patients with progressive supranuclear palsy (PSP), a neurodegenerative disorder with severe neuronal loss in the prefrontal cortex and cholinergic systems, in particular in the… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Supranuclear Palsy, Progressive
- What is being tested?
- donepezil
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PSP
- Age > 30 years old
- Disease duration < 5 years
- Mini mental state (MMS) > 24
- Antisaccades %: 40-80%
Who cannot join
- Other parkinsonian syndromes
- MMS < 24
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE
Paris, 75013
Marie-Laure Welter, MD, 33-42161950, marie-laure.welter@psl.aphp.fr
Bertrand Gaymard, MD, PhD, 33-142162218, gaymard@ccr.jussieu.fr
About this study
The syndrome of distractibility is a behavioral disorder induced by a lesion or a dysfunction of the frontal lobe. This sign is frequent in patients with progressive supranuclear palsy (PSP), a neurodegenerative disorder with severe neuronal loss in the prefrontal cortex and cholinergic systems, in particular in the Meynert basalis nucleus. This could participate in the occurrence of the distractibility in these patients. The aim of this study is to evaluate the effect of the donepezil, an anticholinesterase, on the distractibility in PSP patients, by using oculomotor and neuropsychological assessments.
- Conditions
- Supranuclear Palsy, Progressive
- Being tested
- donepezil
- Keywords
- Progressive supranuclear palsy, Frontal lobe, Oculomotor testing, Neuropsychological scores, Motor disability (UPDRS), Distractibility
- 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.
donepezilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supranuclear Palsy, ProgressiveStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Investigators
- Bertrand Gaymard, MD, PhD, Principal investigator, INSERM-U679
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139373
- Sponsor's protocol ID
- RBM0323
- Status last verified
- Jul 2005
- First submitted
- 30 Aug 2005
- Last updated
- 14 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy
- ClinicalTrials.gov ID
- NCT00139373
- Acronym / sponsor ID
- RBM0323
- Conditions
- Supranuclear Palsy, Progressive
- Keywords
- Progressive supranuclear palsy, Frontal lobe, Oculomotor testing, Neuropsychological scores, Motor disability (UPDRS), Distractibility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- First posted
- 31 Aug 2005 (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.
The syndrome of distractibility is a behavioral disorder induced by a lesion or a dysfunction of the frontal lobe. This sign is frequent in patients with progressive supranuclear palsy (PSP), a neurodegenerative disorder with severe neuronal loss in the prefrontal cortex and cholinergic systems, in particular in the Meynert basalis nucleus. This could participate in the occurrence of the distractibility in these patients. The aim of this study is to evaluate the effect of the donepezil, an anticholinesterase, on the distractibility in PSP patients, by using oculomotor and neuropsychological assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with PSP
- Age > 30 years old
- Disease duration < 5 years
- Mini mental state (MMS) > 24
- Antisaccades %: 40-80%
Key exclusion criteria (2 listed)
- Other parkinsonian syndromes
- MMS < 24
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 |
|---|---|---|
| donepezil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2007.
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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.
Bertrand Gaymard, MD, PhD principal investigator
INSERM-U679
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing donepezil in people with Supranuclear Palsy, Progressive, run by Groupe Hospitalier Pitie-Salpetriere at 1 site 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrand Gaymard, MD, PhD (33-142162218, gaymard@ccr.jussieu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 2007; AzTrials last refreshed its copy on 7 Nov 2026.