DystoniaPhase 3NCT00169403
Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia
A Phase 3 study testing Deep brain stimulation in people with Dystonia, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to: 1. evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and 2. assess the recurrence of the motor symptoms after the switch off. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Dystonia
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic generalised dystonia
- Pallidal stimulation
Who cannot join
- Mini-mental status (MMS) < 24
- Severe psychiatric disorder
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Paris
Marie-Laure Welter, MD, 33-142161950, marie-laure.welter@psl.aphp.fr
Marie Vidailhet, MD, PhD
About this study
Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to:
- evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and
- assess the recurrence of the motor symptoms after the switch off.
- Conditions
- Dystonia
- Being tested
- Deep brain stimulation
- Keywords
- Idiopathic dystonia, deep brain stimulation, globus pallidus, generalised Idiopathic dystonia
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
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 DystoniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Tours
- Investigators
- Marie Vidailhet, MD, PhD, Study director, Hôpital Saint-Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169403
- Sponsor's protocol ID
- P000201
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 29 Aug 2007
- Results posted
- No
Publications
Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tezenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destee A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67. doi: 10.1056/NEJMoa042187.
PubMed 15689584
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia
- ClinicalTrials.gov ID
- NCT00169403
- Acronym / sponsor ID
- P000201
- Conditions
- Dystonia
- Keywords
- Idiopathic dystonia, deep brain stimulation, globus pallidus, generalised Idiopathic dystonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- University Hospital, Tours
- First posted
- 15 Sep 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.
Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to:
- evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and
- assess the recurrence of the motor symptoms after the switch off.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Idiopathic generalised dystonia
- Pallidal stimulation
Key exclusion criteria (2 listed)
- Mini-mental status (MMS) < 24
- Severe psychiatric disorder
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 |
|---|---|---|
| Deep brain stimulation | Procedure or surgery | – |
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 29 Aug 2007.
- Results publication: PubMed 15689584Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tezenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destee A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67. doi: 10.1056/NEJMoa042187.
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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.
Marie Vidailhet, MD, PhD study director
Hôpital Saint-Antoine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deep brain stimulation in people with Dystonia, 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 2 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 29 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Marie Vidailhet, MD, PhD (33-142161950, marie.vidailhet@sat.ap-hop-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169403, 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 29 Aug 2007.