Parkinson's DiseaseMONOTREATNCT01747655
A Post Marketing Observational Study of Activities of Daily Living in Advanced Parkinson's Disease Patients With Early Troublesome Motor Fluctuations and Treated With Duodopa - a Multi-country Study
An observational study of Parkinson's Disease, run by AbbVie (prior sponsor, Abbott).
Trial summary
Patients with advanced Parkinson's Disease experience a range in the severity of their motor fluctuations. The rationale for this Post Marketing Observational Study is to demonstrate the benefits of Duodopa treatment on Parkinson's Disease patients entering the advanced stage of the disease whose motor fluctuations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jul 2015
- Phase
- Observational
- 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
Study population: Hospital clinic
Who may be able to join
- Has advanced levodopa-responsive Parkinson's disease
- The decision to treat with Duodopa is made by the physician in accordance with the local label (Summary of Product Characteristics; product label) prior to any decision to approach the patient to participate in this study
- Parkinson's Disease (PD) medicinal treatment is unchanged for at least four weeks prior to baseline
- Takes oral medication four or more times daily
- Either has 2-4 hours of "off" time or 2 hours of non-troublesome or troublesome dyskinesia daily supported by a Unified Parkinson's Disease Rating Scale (UPDRS) Total Score in the best "on" state of at least 40 points at baseline; based on documented medical history
Who cannot join
- Use of Deep Brain Stimulation (DBS), Apomorphine pump or Duodopa treatment prior to baseline visit
- Severe dementia based on a Mini-Mental State Examination (MMSE) of < 24
About this study
Official title: A Post Marketing Observational Study of Activities of Daily Living in Advanced Parkinson's Disease Patients With Early Troublesome Motor Fluctuations and Treated With Duodopa - a Multi-country Study - MONOTREAT
Patients with advanced Parkinson's Disease experience a range in the severity of their motor fluctuations. The rationale for this Post Marketing Observational Study is to demonstrate the benefits of Duodopa treatment on Parkinson's Disease patients entering the advanced stage of the disease whose motor fluctuations have become troublesome and complicate management with oral therapy. The aim of this post-marketing observational study is to assess the effect of Duodopa treatment on activities of daily living in advanced Parkinson's Disease participants characterised by either 2-4 hours of "off" time or 2 hours of non-troublesome or troublesome dyskinesia daily, supported by a Unified Parkinson's Disease Rating Scale Total Score in the best "on" state of at least 40 points at baseline.
Read the detailed description
Data are recorded from visits most closely aligned with the planned periods of Visit 0 (V0): Baseline (After decision to use the temporary naso-duodenal tube (approximately 2-14 days) and after signature of the Patient Authorization/Informed Consent Form); Visit 1 (V1): At discharge from hospital; Visit 2 (V2): 3 months after discharge; Visit 3 (V3): 6 months after discharge; Visit 4 (V4): 12 months after discharge.
All participants have a temporary naso-duodenal tube used initially with the infusion pump to determine if the participant responds favorably to this method of treatment and to optimize the dose of Duodopa before permanent treatment is started.
Participants who choose a treatment other than Duodopa after the temporary naso-duodenal test phase are considered for the Standard of Care group. Participants who go on to select Apomorphine pump or Deep Brain Stimulation at any stage are not eligible to continue in this group or to continue in the observational period of study.
Participants who continue to with Duodopa treatment after the the temporary naso-duodenal test phase are the Duodopa group.
- Conditions
- Parkinson's Disease
- Keywords
- Early Observational Advanced, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Duodopa | Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J) | |
| Standard of Care | Participants that return to oral or transdermal anti-parkinson's disease medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during "On" time (when PD symptoms are well controlled by the drug) are presented. Last observation carried forward (LOCF) was used for missing data.
Measured: Baseline (Week 0) and 12 months after hospital discharge
Secondary outcomes (15)
Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during "On" time (when PD symptoms are well controlled by the drug) are presented. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment
The percentage of participants who continued with PEG-J treatment after treatment via temporary naso-jejunal tube.
Measured: 14 days
Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study
The primary reasons for stopping treatment with Duodopa or for discontinuing the study.
Measured: 12 months
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 32 (Duration) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 33 (Disability) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 34 (Pain) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Clinical Fluctuations) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
The UPDRS III questionnaire consists of 14 questions on motor examinations rated from 0 (absent/normal) to 4 (extreme impairment). Questions 20-26 are multi-part questions in that they are evaluated separately for multiple body parts (for example, for the left and right hand). Counting each of these assessments leads to a total of 27 answers. The UPDRS III score ranges from 0 to 108 with higher values indicating greater impairment and was calculated as the sum of the 27 answers provided to the 14 questions. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS Rating Scale) Total Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Non-motor symptoms assessed over the previous month were scored with respect to severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) and with respect to frequency (1 = rarely, 2 = often, 3 = frequent, 4 = very frequent). The total NMSS score ranges from 0 to 360 with higher values indicating greater impairment and was calculated as the sum of all individual score values. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Parkinson's Disease Quality of Life Questionnaire (PDQ-8) Summary Index Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Participants were asked to state how often they had encountered certain problems over the past four weeks using the following rating scale: Never (0), occasionally (1), sometimes (2), often (3), always or cannot do at all (4). The PDQ-8 summary index was derived as the sum of the single items divided by 32. Scores range from 0 to 100. A higher summary index score indicates a higher impairment of quality of life. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0), at discharge from hospital, and 3, 6, and 12 months after hospital discharge
Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Healthcare Resource Utilization (HCRU) Received Assistance at Home: Percentage of Participants Who Received Assistance at Home at 3, 6, and 12 Months After Hospital Discharge
Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge
Participants were asked about their utilization of healthcare resources within the previous 3 months , including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.
Measured: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionJul 2015
- Study completionJul 2015
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koray Onuk, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747655
- Sponsor's protocol ID
- P13-893
- Acronym
- MONOTREAT
- Status last verified
- Oct 2016
- First submitted
- 10 Dec 2012
- Last updated
- 13 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Observational Study of Activities of Daily Living in Advanced Parkinson's Disease Patients With Early Troublesome Motor Fluctuations and Treated With Duodopa - a Multi-country Study - MONOTREAT
- ClinicalTrials.gov ID
- NCT01747655
- Acronym / sponsor ID
- MONOTREAT / P13-893
- Conditions
- Parkinson's Disease
- Keywords
- Early Observational Advanced, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Posted 13 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with advanced Parkinson's Disease experience a range in the severity of their motor fluctuations. The rationale for this Post Marketing Observational Study is to demonstrate the benefits of Duodopa treatment on Parkinson's Disease patients entering the advanced stage of the disease whose motor fluctuations have become troublesome and complicate management with oral therapy. The aim of this post-marketing observational study is to assess the effect of Duodopa treatment on activities of daily living in advanced Parkinson's Disease participants characterised by either 2-4 hours of "off" time or 2 hours of non-troublesome or troublesome dyskinesia daily, supported by a Unified Parkinson's Disease Rating Scale Total Score in the best "on" state of at least 40 points at baseline.
Detailed description
Data are recorded from visits most closely aligned with the planned periods of Visit 0 (V0): Baseline (After decision to use the temporary naso-duodenal tube (approximately 2-14 days) and after signature of the Patient Authorization/Informed Consent Form); Visit 1 (V1): At discharge from hospital; Visit 2 (V2): 3 months after discharge; Visit 3 (V3): 6 months after discharge; Visit 4 (V4): 12 months after discharge.
All participants have a temporary naso-duodenal tube used initially with the infusion pump to determine if the participant responds favorably to this method of treatment and to optimize the dose of Duodopa before permanent treatment is started.
Participants who choose a treatment other than Duodopa after the temporary naso-duodenal test phase are considered for the Standard of Care group. Participants who go on to select Apomorphine pump or Deep Brain Stimulation at any stage are not eligible to continue in this group or to continue in the observational period of study.
Participants who continue to with Duodopa treatment after the the temporary naso-duodenal test phase are the Duodopa group.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duodopa | – | –Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J) |
| Standard of Care | – | –Participants that return to oral or transdermal anti-parkinson's disease medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital clinic
Key inclusion criteria (5 listed)
- Has advanced levodopa-responsive Parkinson's disease
- The decision to treat with Duodopa is made by the physician in accordance with the local label (Summary of Product Characteristics; product label) prior to any decision to approach the patient to participate in this study
- Parkinson's Disease (PD) medicinal treatment is unchanged for at least four weeks prior to baseline
- Takes oral medication four or more times daily
- Either has 2-4 hours of "off" time or 2 hours of non-troublesome or troublesome dyskinesia daily supported by a Unified Parkinson's Disease Rating Scale (UPDRS) Total Score in the best "on" state of at least 40 points at baseline; based on documented medical history
Key exclusion criteria (2 listed)
- Use of Deep Brain Stimulation (DBS), Apomorphine pump or Duodopa treatment prior to baseline visit
- Severe dementia based on a Mini-Mental State Examination (MMSE) of < 24
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 12 months after hospital discharge
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during "On" time (when PD symptoms are well controlled by the drug) are presented. Last observation carried forward (LOCF) was used for missing data.
15 secondary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment
Time frame: 14 days
Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study
Time frame: 12 months
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 32 (Duration) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 33 (Disability) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 34 (Pain) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Clinical Fluctuations) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS Rating Scale) Total Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Parkinson's Disease Quality of Life Questionnaire (PDQ-8) Summary Index Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0), at discharge from hospital, and 3, 6, and 12 months after hospital discharge
Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Healthcare Resource Utilization (HCRU) Received Assistance at Home: Percentage of Participants Who Received Assistance at Home at 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge
Time frame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink 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.
Koray Onuk, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by AbbVie (prior sponsor, Abbott).
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: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 13 Oct 2016). 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?
Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge (time frame: Baseline (Week 0) and 12 months after hospital discharge). 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 13 Oct 2016.