Parkinson´s DiseasePhase 4NCT03103919
Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
A Phase 4 study testing Kinesia-ONE™, Kinesia-360™ and Rotigotine in people with Parkinson´s Disease, run by UCB Biopharma S.P.R.L. at 8 sites in United States.
Trial summary
Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence to Neupro compared with only standard clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson´s Disease
- What is being tested?
- Kinesia-ONE™, Kinesia-360™ and Rotigotine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 Mar 2017to 2 Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is newly prescribed Neupro and is expected to commence Neupro treatment. Historical Neupro treatment is permitted
- Informed Consent form (ICF) is signed and dated by the subject, before any study-related procedures
- Subject is considered reliable and capable of adhering to the protocol, visit schedule, completion of the diary, and using Kinesia devices according to the judgment of the Investigator
- Male or female subject, >=18 years of age at the time of the Screening Visit
- Subject has Parkinson's disease, defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: tremor at rest, rigidity or impairment of postural reflexes, and without any other known or suspected cause of Secondary Parkinsonism
- Subject experiences motor symptoms associated with Parkinson's disease that are not sufficiently controlled by current therapy. The average of the triplicate resting tremor scores and triplicate finger tapping scores from Kinesia-ONE™ (6 scores in total) must be >1.0
Who cannot join
- Subject is currently participating in any study with an investigational medicinal product or investigational device
- Subject has any medical, neurological or psychiatric condition which, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
- Subject with Deep Brain Stimulation (DBS) device implant
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Pd0049 102
Boca Raton, Florida, 33486
Pd0049 106
Commack, New York, 11725
Pd0049 105
Fountain Valley, California, 92708
Pd0049 107
Greenville, South Carolina, 29615
Pd0049 109
Houston, Texas, 77030
Pd0049 103
Kansas City, Kansas, 66160
Pd0049 104
Tulsa, Oklahoma, 74136
Pd0049 108
Winfield, Illinois, 60190
About this study
Official title: A Multicenter, Open-Label, Two-Arm Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence to Neupro compared with only standard clinical practice.
- Conditions
- Parkinson´s Disease
- Being tested
- Kinesia-ONE™, Kinesia-360™, Rotigotine
- Keywords
- Parkinson´s Disease, Kinesia-360™, Kinesia-ONE™, Biosensor
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesia-ONE™Device
Kinesia-ONE™ wearable sensor uses a subject-worn finger sensor and iPad mini application (APP) to objectively measure specific motor tasks related to Parkinson's disease symptoms such as tremor, bradykinesia (slowed movements), and dyskinesia (involuntary movements) in the Investigator's office. Subjects should wear the Kinesia-ONE™ device on the most affected side.
Kinesia-360™Device
Kinesia-360™ wearable sensor includes a wrist and ankle device, along with a cell phone, which is also APP-based, and is designed for continuous day time monitoring of Parkinson's disease symptoms. Subjects will wear Kinesia-360™ while they go about their daily lives, and symptom severity is continually captured to enable objective assessment of Parkinson's disease symptoms. Subjects should wear the Kinesia-360™ device bands on the most affected side.
RotigotineDrug
Also called Neupro
All subjects will start Neupro treatment at a dose of either rotigotine 2 mg/24 h or 4 mg/24 h (according to the disease stage of the subject) which will then be adjusted based on symptom assessment either via standard care alone or via a combination of standard care and evaluation of the recordings made available by the Kinesia wearable technologies.
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine + Standard Care | Active comparator | Subjects will use the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject will be determined by standard clinical practice. Receives: Device: Kinesia-ONE™; Drug: Rotigotine |
| Rotigotine + Standard Care + Kinesia-360™ wearable device | Experimental | Subjects will use the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects will use the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator will use these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. Receives: Device: Kinesia-ONE™; Device: Kinesia-360™; Drug: Rotigotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score
UPDRS Part III has 27 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 27 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 108, where the maximum score indicates the worse condition. A negative value in change in Unified Parkinson's Disease Rating Scale indicates improvement, whereas a positive value indicates worsening of disease.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro)
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. The finger tapping speed scores and resting tremor scores were averaged and provided as one score ranging from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Measured: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Neupro Dose Per 24h at Visit 2 (Week 12)
Daily dose of study medication taken at respective visit.
Measured: Visit 2 (Week 12)
Number of Neupro Dose Changes During the Study
Dose adjustments during study are performed per standard of care.
Measured: Visit 1 (Week 1) to Visit 2 (Week 12)
Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study
Number of subjects who discontinued Neupro Treatment were recorded.
Measured: Visit 1 (Week 1) to Visit 2 (Week 12)
Secondary outcomes (1)
Number of Subjects With Any Adverse Events During the Course of the Study
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: Visit 1 (Week 1) to Visit 2 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start16 Mar 2017
- Primary completion2 Jan 2018
- Study completion2 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson´s DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103919
- Sponsor's protocol ID
- PD0049
- Status last verified
- Feb 2019
- First submitted
- 30 Mar 2017
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Two-Arm Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
- ClinicalTrials.gov ID
- NCT03103919
- Acronym / sponsor ID
- PD0049
- Conditions
- Parkinson´s Disease
- Keywords
- Parkinson´s Disease, Kinesia-360™, Kinesia-ONE™, Biosensor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence to Neupro compared with only standard clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotigotine + Standard Care | Active comparator | Device: Kinesia-ONE™, Drug: RotigotineSubjects will use the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject will be determined by standard clinical practice. |
| Rotigotine + Standard Care + Kinesia-360™ wearable device | Experimental | Device: Kinesia-ONE™, Device: Kinesia-360™, Drug: RotigotineSubjects will use the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects will use the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator will use these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is newly prescribed Neupro and is expected to commence Neupro treatment. Historical Neupro treatment is permitted
- Informed Consent form (ICF) is signed and dated by the subject, before any study-related procedures
- Subject is considered reliable and capable of adhering to the protocol, visit schedule, completion of the diary, and using Kinesia devices according to the judgment of the Investigator
- Male or female subject, >=18 years of age at the time of the Screening Visit
- Subject has Parkinson's disease, defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: tremor at rest, rigidity or impairment of postural reflexes, and without any other known or suspected cause of Secondary Parkinsonism
Key exclusion criteria (3 listed)
- Subject is currently participating in any study with an investigational medicinal product or investigational device
- Subject has any medical, neurological or psychiatric condition which, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
- Subject with Deep Brain Stimulation (DBS) device implant
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 |
|---|---|---|
| Kinesia-ONE™Kinesia-ONE™ wearable sensor uses a subject-worn finger sensor and iPad mini application (APP) to objectively measure specific motor tasks related to Parkinson's disease symptoms such as tremor, bradykinesia (slowed movements), and dyskinesia (involuntary movements) in the Investigator's office. Subjects should wear the Kinesia-ONE™ device on the most affected side. | Device | Rotigotine + Standard Care, Rotigotine + Standard Care + Kinesia-360™ wearable device |
| Kinesia-360™Kinesia-360™ wearable sensor includes a wrist and ankle device, along with a cell phone, which is also APP-based, and is designed for continuous day time monitoring of Parkinson's disease symptoms. Subjects will wear Kinesia-360™ while they go about their daily lives, and symptom severity is continually captured to enable objective assessment of Parkinson's disease symptoms. Subjects should wear the Kinesia-360™ device bands on the most affected side. | Device | Rotigotine + Standard Care + Kinesia-360™ wearable device |
| RotigotineAlso: NeuproAll subjects will start Neupro treatment at a dose of either rotigotine 2 mg/24 h or 4 mg/24 h (according to the disease stage of the subject) which will then be adjusted based on symptom assessment either via standard care alone or via a combination of standard care and evaluation of the recordings made available by the Kinesia wearable technologies. | Drug | Rotigotine + Standard Care, Rotigotine + Standard Care + Kinesia-360™ wearable device |
Primary outcome
Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro)
UPDRS Part III has 27 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 27 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 108, where the maximum score indicates the worse condition. A negative value in change in Unified Parkinson's Disease Rating Scale indicates improvement, whereas a positive value indicates worsening of disease.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. The finger tapping speed scores and resting tremor scores were averaged and provided as one score ranging from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
Neupro Dose Per 24h at Visit 2 (Week 12)
Time frame: Visit 2 (Week 12)
Daily dose of study medication taken at respective visit.
Number of Neupro Dose Changes During the Study
Time frame: Visit 1 (Week 1) to Visit 2 (Week 12)
Dose adjustments during study are performed per standard of care.
Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study
Time frame: Visit 1 (Week 1) to Visit 2 (Week 12)
Number of subjects who discontinued Neupro Treatment were recorded.
1 secondary outcome
Number of Subjects With Any Adverse Events During the Course of the Study
Time frame: Visit 1 (Week 1) to Visit 2 (Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Product InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
UCB Cares study director
+1 844 599 2273 (UCB)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kinesia-ONE™, Kinesia-360™ and Rotigotine in people with Parkinson´s Disease, run by UCB Biopharma S.P.R.L. at 8 sites in United States.
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 3 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score (time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro)). The study lists 14 primary outcomes in all. 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 19 Feb 2019.