Parkinson Disease (PD)SO-TOPNCT07074119
Sensor-Based Optimization of Therapy for Parkinson's Disease Patients With Motor Fluctuations
A study testing wearable-based adjustment therapy in people with Parkinson Disease (PD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Although numerous tools have been developed in recent years with the enhancement of new technologies precision and the reduction of their size, still few medical devices are used in clinical routine in Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 46 to 83 years
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- wearable-based adjustment therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 46 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's since > 4 years
- Patient between years 46-83 (according to the BWS range of validity)
- Presence of motor fluctuations as defined by a score ≥ 2 (item 4.3) and a score ≥ 1 (item 4.4) of the MDS-UPDRS part IV
- At least 3 doses per day of L-Dopa
- Need of therapeutic adjustment because of motor fluctuations according to the neurologist opinion
- Hoehn and Yahr stage ≤ 3 in OFF state
Who cannot join
- No signature of informed consent
- Anticipated uncompliance or inability to use the self-reported diary or to wear the devices
- Cognitive impairment (MMSE < 24)
- Patient treated with second line therapies ((Subcutaneous or digestive pump therapies or deep brain stimulation) or planed for the 6 next months.
- Pregnant or breastfeeding women
- Patients living in nursing home
- Patient already participating in another clinical investigation or interventional study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre d'investigations cliniques Pitié-Salpêtrière University Hospital
Paris, Île-de-France Region, 75013
David Grabli, Professor, 01 42 16 24 61, david.grabli@aphp.fr
Sofia Zemouri, Master-Project Manager, 01 42 16 24 61, jean-christophe.corvol@aphp.fr
About this study
Although numerous tools have been developed in recent years with the enhancement of new technologies precision and the reduction of their size, still few medical devices are used in clinical routine in Parkinson's Disease. Knowledge about Parkinson's Disease motor symptoms has been widely improved especially thanks to objective monitoring of movements. However, patients are mostly observed in defined environment during scripted activities, which is per se distinct from the real life conditions. Besides, experts may agree on the limitations of the diary that is supposed to reflect the patient's status at home, while outpatients' visits may also not correctly enable the neurologist to catch up the everyday life condition of the patient. In order to overcome some of these issues, we hypothesize that the implementation of body-worn sensors at home monitoring could provide promising solutions. Yet, important information is missing: there is no previous randomized trial studying the additional value of body-worn sensors to improve motor symptoms, quality of life and ability to perform everyday life activities for example. To our knowledge, our study proposal is the first one to adjust therapy of patients with Parkinson's Disease based on the reports of body-worn sensors monitoring. If the efficacy and reliability of at home monitoring with sensors is proven, new healthcare guidelines could arise with the objective of a better and continuous patient's follow-up, remotely from the outpatient's visit.
Read the detailed description
The study is Single Blind Randomized clinical trial. The participants are patients with Parkinson's Disease at the stage of motor fluctuations without dementia or levodopa-resistant axial symptoms who need therapeutic adjustments according to the neurologist opinion. The primary objectif is to assess the efficacy of the Body Worn Sensors (BWS)-based adjustment therapy, on add-on to usual care, on change in time spent in OFF state in PD patients with motor fluctuation requiring treatment adaptation. The primary endpoint is the change in daily time spent in OFF state between baseline and 6 months visit, measured as the mean daily time in OFF state upon 3 days on self-reported diary. Medical device under investigation, CE-marked (class IIA) under regulation UE 2017/745, is a body-worn sensor (BWS) that measures movements and analyses accelerometry data to report motor symptoms of Parkinson's Disease. The product is the PKG system (Global Kinetics Corporation, Melbourne Australia). This BWS embarks a dedicated algorithm that continuously reports severity scores of bradykinesia, dyskinesia and tremor over a week of monitoring. All the patients will wear the PKG Watch but results from BWS recording will be available for the neurologist to adapt the treatment, according to randomization allocation (Available in the experimental group only). In both groups (experimental and control group), the treatment will be adapted according to current guidelines. Four follow-up visits will be performed at M0 (W0), M1 (W4 +/- 7 days), M3 (W12 +/- 7 days) and M6 (W24 +/- 7 days) during outpatients clinics (except for M1 = phone call) where participants are usually followed. 13 centers in France participating to the NS-PARK network (French research Network for PD). The duration of recruitment will be 24 months. The duration of participation for each participant will be 6 months, the total duration of the study will be 31 months. For this study, 218 patients will be recruited.
- Conditions
- Parkinson Disease (PD)
- Being tested
- wearable-based adjustment therapy
- Keywords
- Adjusment Therapy, Dyskinesis, Time ON, Time OFF, Bradykinesia, Parkinson Kinetic Graff, Body-worn Sensors, self-reported diary
- Medical subject headings
- Parkinson Disease, Dyskinesias, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable-based adjustment therapyDevice
- Patients will wear the BWS for 7 days prior to each of the visit : baseline (V1) at week 0, V2 at week 4 (phone call at 1 month), V3 at week 12 (3 months visit) and V4 at week 24 (6 months).
- Data extracted from each session of monitoring with the BWS will be made available to the neurologist (only in the experimental group) prior to V1 (W0), V2 (W4), V3 (W12) and V4 (W24) respectively
- Treatment adjustment will be guided by the current consensus guidelines for treatment adjustment for motor fluctuations in PD using reports from BWS data. Reports will be screened by neurologists before the patient's visit so the groups blinding is correctly observed
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients of the control group will undergo the same protocol as patients in the experimental arm. However, data extracted from the BWS will be made available to the neurologist. Receives: Device: wearable-based adjustment therapy |
| Control group | Active comparator | Patients of the control group will undergo the same protocol as patients in the experimental arm. However, data extracted from the BWS will be blinded and NOT be made available to the neurologist. Receives: Device: wearable-based adjustment therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily time spent in OFF state between baseline and 6 months visit, measured as the mean daily time in OFF state upon 3 days on self-reported diary.
The daily time spent in OFF states will be reported by the patient on his/her diary per periods of thirty minutes each day for a duration of 3 days before baseline visit and before 6 months visit. For each day, the total daily time spent OFF will be calculated as the sum of every 30 minutes' periods stated as OFF time. This duration will be averaged over the 3 days period at baseline (W0 +/-7 days) and 6 months (W24 +/- 7 days) visits and the difference between the two visits will be calculated.
Measured: Baseline (W0) and 6 months visit (W24)
Secondary outcomes (11)
Change in time spent in good ON state without troublesome dyskinesia (i.e. good time ON) between baseline and 6 months on self-reported diary (mean of previous 3 days)
For each day, the total time spent in ON state without troublesome dyskinesia will be calculated as the sum of every 30 minutes periods stated as time spent in ON state without troublesome dyskinesia.
Measured: Baseline (W0) and 6 months visits (W24)
Change in time spent in ON state with troublesome dyskinesia between baseline and 6 months on self-reported diary (mean of previous 3 days)
For each day, the total time spent in ON state with troublesome dyskinesia will be calculated as the sum of every 30 minutes periods stated as time spent in ON state with troublesome dyskinesia in the diary. These durations will be averaged over the 3 days period at baseline (W0 +/- 7 days) and 6 months visits (W24 +/- 7 days) and the difference between the two visits will be calculated.
Measured: baseline (W0) and 6 months visits (W24)
Change of Movement Disorder Society-Unified Parkinson's Disease Rating Scale part II (MDS-UPDRS part II-motor aspects of experiences of daily living) between baseline and 6 months
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale part II (MDS-UPDRS part II ) score will be assessed at baseline and 6 months visits. The change will be calculated as the difference between the scores obtained at 6 months visit (W24 +/- 7 days) and baseline visit (W0 +/- 7 days).
The minimum score of the MDS-UPDRS part II is 0 and the maximum score is 52, the higher score means a worse outcome.
Measured: baseline (W0) and 6 months visits (W24)
Change of the score of Parkinson Disease Quality of life questionnaire (PDQ-39) related between baseline and 6 months
The Parkinson Disease Quality of life questionnaire (PDQ-39) is a self-questionnaire assessing disease related quality of life in PD. The patient will fill it in at baseline and 6 months visits. The change will be calculated as the difference between the scores obtained at 6 months visit (W24 +/- 7 days) and baseline visit (W0 +/- 7 days).
The minimum score of the Parkinson Disease Quality of 0 and the maximum score is 156, the higher score means a worse outcome.
Measured: baseline (W0) and 6 months visits (W24)
Number of patients with at least one dopaminergic drug-related side effects between groups during the study period.
Dopaminergic drug-related side effects will be collected at each visit: baseline (W0 +/- 7 days), phone call at 1 months (W4 +/- 7 days), 3 months visit (W12 +-/ 7 days), 6 months visit (W24 +/- 7 days). AE will be classified as related or not with anti-parkinsonian drug and rated according to their severity. The number and severity of anti-parkinsonian drug side effects will be compared across groups.
Measured: baseline (W0), 1 month visit (W4), 3 months visit (W12) and 6 months (W24)
Number of patients with each type of Dopaminergic drug-related
The side effects will be described in each group
Measured: baseline (W0), phone call at 2 months (W4 ), 3 months visit (W12 ), 6 months visit (W24)
Change of Movement Disorder Society-Unified Parkinson's Disease Rating Scale part I (MDS-UPDRS part I-non-motor aspects of experiences of daily living) between baseline and 6 months
Movement Disorder Society-Unified Parkinson's Disease Rating Scale part I (MDS-UPDRS part I) score will be assessed at baseline and 6 months visits. The change will be calculated as the difference between the scores obtained at 6 months visit (W24 +/- 7 days) and baseline visit (W0 +/- 7 days).
The minimum score of the MDS-UPDRS part I is 0 and the maximum score is 52, the higher score means a worse outcome.
Measured: baseline (W0) and 6 months visits (W24)
Changes in drug regimen during the study of Levodopa equivalent daily doses (LEDD) between baseline and 6 months
The change in LEDD between 6 months visit (V4) and baseline visit (V1) will be calculated as the difference.
Measured: baseline (W0) and 6 months visit (W24)
Changes in drug regimens between baseline and 6 months
Antiparkinsonian and associated treatments will be systematically collected at baseline (W0 +/- 7 days) and 6 months (W24 +/- 7 days) visits. The number and type of changes (i.e. addition of drugs, discontinuation of drugs, increase / decrease of dosing) between baseline visit (W0) and 6 months visit (W24 +/- 7 days) will be described.
Measured: baseline (W0) and 6 months visits (W24)
Number of consultations between baseline visit (W0) and 6 months visit
Number of consultations (general practitioner, neurologist, other specialist, advanced practice nurse) between baseline visit (W0) and 6 months visit (W24 +/- 7 days)
Measured: baseline (W0) and 6 months visits (W24)
Number of hospitalization days between baseline visit (W0) and 6 months visit
Measured: baseline (W0) and 6 months visits (W24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study startOct 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- NS-PARK Network
- Responsible party
- Sponsor
- Investigators
- David Grabli, Professor, Principal investigator, Assistance Publique - Hôpitaux de ParisJean Chritophe Corvol, Professor, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074119
- Sponsor's protocol ID
- APHP180609
- Other IDs
- 2019-A00322-55
- Acronym
- SO-TOP
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor-Based Optimization of Therapy for Parkinson's Disease Patients With Motor Fluctuations
- ClinicalTrials.gov ID
- NCT07074119
- Acronym / sponsor ID
- SO-TOP / APHP180609
- Conditions
- Parkinson Disease (PD)
- Keywords
- Adjusment Therapy, Dyskinesis, Time ON, Time OFF, Bradykinesia, Parkinson Kinetic Graff, Body-worn Sensors, self-reported diary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- NS-PARK Network
- Study start
- Oct 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 20 Jul 2025 (actual)
- 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.
Although numerous tools have been developed in recent years with the enhancement of new technologies precision and the reduction of their size, still few medical devices are used in clinical routine in Parkinson's Disease. Knowledge about Parkinson's Disease motor symptoms has been widely improved especially thanks to objective monitoring of movements. However, patients are mostly observed in defined environment during scripted activities, which is per se distinct from the real life conditions. Besides, experts may agree on the limitations of the diary that is supposed to reflect the patient's status at home, while outpatients' visits may also not correctly enable the neurologist to catch up the everyday life condition of the patient. In order to overcome some of these issues, we hypothesize that the implementation of body-worn sensors at home monitoring could provide promising solutions. Yet, important information is missing: there is no previous randomized trial studying the additional value of body-worn sensors to improve motor symptoms, quality of life and ability to perform everyday life activities for example. To our knowledge, our study proposal is the first one to adjust therapy of patients with Parkinson's Disease based on the reports of body-worn sensors monitoring. If the efficacy and reliability of at home monitoring with sensors is proven, new healthcare guidelines could arise with the objective of a better and continuous patient's follow-up, remotely from the outpatient's visit.
Detailed description
The study is Single Blind Randomized clinical trial. The participants are patients with Parkinson's Disease at the stage of motor fluctuations without dementia or levodopa-resistant axial symptoms who need therapeutic adjustments according to the neurologist opinion. The primary objectif is to assess the efficacy of the Body Worn Sensors (BWS)-based adjustment therapy, on add-on to usual care, on change in time spent in OFF state in PD patients with motor fluctuation requiring treatment adaptation. The primary endpoint is the change in daily time spent in OFF state between baseline and 6 months visit, measured as the mean daily time in OFF state upon 3 days on self-reported diary. Medical device under investigation, CE-marked (class IIA) under regulation UE 2017/745, is a body-worn sensor (BWS) that measures movements and analyses accelerometry data to report motor symptoms of Parkinson's Disease. The product is the PKG system (Global Kinetics Corporation, Melbourne Australia). This BWS embarks a dedicated algorithm that continuously reports severity scores of bradykinesia, dyskinesia and tremor over a week of monitoring. All the patients will wear the PKG Watch but results from BWS recording will be available for the neurologist to adapt the treatment, according to randomization allocation (Available in the experimental group only). In both groups (experimental and control group), the treatment will be adapted according to current guidelines. Four follow-up visits will be performed at M0 (W0), M1 (W4 +/- 7 days), M3 (W12 +/- 7 days) and M6 (W24 +/- 7 days) during outpatients clinics (except for M1 = phone call) where participants are usually followed. 13 centers in France participating to the NS-PARK network (French research Network for PD). The duration of recruitment will be 24 months. The duration of participation for each participant will be 6 months, the total duration of the study will be 31 months. For this study, 218 patients will be recruited.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: wearable-based adjustment therapyPatients of the control group will undergo the same protocol as patients in the experimental arm. However, data extracted from the BWS will be made available to the neurologist. |
| Control group | Active comparator | Device: wearable-based adjustment therapyPatients of the control group will undergo the same protocol as patients in the experimental arm. However, data extracted from the BWS will be blinded and NOT be made available to the neurologist. |
Who may qualify
- Ages
- 46 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Parkinson's since > 4 years
- Patient between years 46-83 (according to the BWS range of validity)
- Presence of motor fluctuations as defined by a score ≥ 2 (item 4.3) and a score ≥ 1 (item 4.4) of the MDS-UPDRS part IV
- At least 3 doses per day of L-Dopa
- Need of therapeutic adjustment because of motor fluctuations according to the neurologist opinion
Key exclusion criteria (7 listed)
- No signature of informed consent
- Anticipated uncompliance or inability to use the self-reported diary or to wear the devices
- Cognitive impairment (MMSE < 24)
- Patient treated with second line therapies ((Subcutaneous or digestive pump therapies or deep brain stimulation) or planed for the 6 next months.
- Pregnant or breastfeeding women
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 |
|---|---|---|
| wearable-based adjustment therapy* Patients will wear the BWS for 7 days prior to each of the visit : baseline (V1) at week 0, V2 at week 4 (phone call at 1 month), V3 at week 12 (3 months visit) and V4 at week 24 (6 months). * Data extracted from each session of monitoring with the BWS will be made available to the neurologist (only in the experimental group) prior to V1 (W0), V2 (W4), V3 (W12) and V4 (W24) respectively * Treatment adjustment will be guided by the current consensus guidelines for treatment adjustment for motor fluctuations in PD using reports from BWS data. Reports will be screened by neurologists before the patient's visit so the groups blinding is correctly observed | Device | Control group, Experimental group |
Primary outcome
Change in daily time spent in OFF state between baseline and 6 months visit, measured as the mean daily time in OFF state upon 3 days on self-reported diary.
Time frame: Baseline (W0) and 6 months visit (W24)
The daily time spent in OFF states will be reported by the patient on his/her diary per periods of thirty minutes each day for a duration of 3 days before baseline visit and before 6 months visit. For each day, the total daily time spent OFF will be calculated as the sum of every 30 minutes' periods stated as OFF time. This duration will be averaged over the 3 days period at baseline (W0 +/-7 days) and 6 months (W24 +/- 7 days) visits and the difference between the two visits will be calculated.
11 secondary outcomes
Change in time spent in good ON state without troublesome dyskinesia (i.e. good time ON) between baseline and 6 months on self-reported diary (mean of previous 3 days)
Time frame: Baseline (W0) and 6 months visits (W24)
Change in time spent in ON state with troublesome dyskinesia between baseline and 6 months on self-reported diary (mean of previous 3 days)
Time frame: baseline (W0) and 6 months visits (W24)
Change of Movement Disorder Society-Unified Parkinson's Disease Rating Scale part II (MDS-UPDRS part II-motor aspects of experiences of daily living) between baseline and 6 months
Time frame: baseline (W0) and 6 months visits (W24)
Change of the score of Parkinson Disease Quality of life questionnaire (PDQ-39) related between baseline and 6 months
Time frame: baseline (W0) and 6 months visits (W24)
Number of patients with at least one dopaminergic drug-related side effects between groups during the study period.
Time frame: baseline (W0), 1 month visit (W4), 3 months visit (W12) and 6 months (W24)
Number of patients with each type of Dopaminergic drug-related
Time frame: baseline (W0), phone call at 2 months (W4 ), 3 months visit (W12 ), 6 months visit (W24)
Change of Movement Disorder Society-Unified Parkinson's Disease Rating Scale part I (MDS-UPDRS part I-non-motor aspects of experiences of daily living) between baseline and 6 months
Time frame: baseline (W0) and 6 months visits (W24)
Changes in drug regimen during the study of Levodopa equivalent daily doses (LEDD) between baseline and 6 months
Time frame: baseline (W0) and 6 months visit (W24)
Changes in drug regimens between baseline and 6 months
Time frame: baseline (W0) and 6 months visits (W24)
Number of consultations between baseline visit (W0) and 6 months visit
Time frame: baseline (W0) and 6 months visits (W24)
Number of hospitalization days between baseline visit (W0) and 6 months visit
Time frame: baseline (W0) and 6 months visits (W24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
David Grabli, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
Jean Chritophe Corvol, Professor study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearable-based adjustment therapy in people with Parkinson Disease (PD), run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Grabli, Professor (01 42 16 24 61, david.grabli@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily time spent in OFF state between baseline and 6 months visit, measured as the mean daily time in OFF state upon 3 days on self-reported diary. (time frame: Baseline (W0) and 6 months visit (W24)). It is what the study was designed to measure, not a finding.
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 2 Sep 2026.