Parkinson DiseaseNCT03336307
Predictors of Gait Improvement in Patients With Parkinson's Disease After Rehabilitation
An observational study of Parkinson Disease and Movement Disorders, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Patients with Parkinson's disease show a gait disturbance which is considered as one of the most disabling aspect of the disease that strongly impacts on patients' autonomy and quality of life. Read more about this study
- Who is it for?
- Ages 48 to 80 years
- Conditions the study is for
- Parkinson Disease, Movement Disorders
- What is being tested?
- Rehabilitation program
- Type of treatment
- Pill or oral medicine
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- May 2014to Jul 2017
- Phase
- Observational
- 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 48 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fifty out of 67 patients with idiopathic PD assessed for eligibility were recruited at Rehabilitation Unit of Department of Medical and Surgical Sciences and Biotechnologies, University of Rome, Sapienza, and at Rehabilitation Unit of Policlinico Italia Centre, Rome, Italy. Patients were admitted for outpatient rehabilitation between May 2014 and April 2017. All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks. All participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase. Patients' clinical and anthropometric characteristics. Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system.
Who may be able to join
- Diagnosis of idiopathic PD according to UK bank criteria
- Hoehn and Yahr stages 1 to 3.
- All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks
Who cannot join
- Cognitive deficits (defined as scores of <26 on the Mini-Mental State Examination [MMSE]),
- moderate or severe depression (defined as scores of >17 on the Beck Depression Inventory [BDI]), -. orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with Parkinson's disease show a gait disturbance which is considered as one of the most disabling aspect of the disease that strongly impacts on patients' autonomy and quality of life. The mechanism underlying gait impairment is multi-factorial, reflects the global motor impairment of patients with PD and is mainly related to a neurotransmitter deficiency inducing bradykinesia, rigidity, abnormal trunk control and postural instability. For this reason, and considering the impact of social and economic costs, one of the main foci of intervention in patients with PD should be treating gait abnormalities. This need is further reinforced by the knowledge that gait outcomes are correlated with longevity, cognitive decline and adverse events.
Besides the shorten-step gait clinical description of the gait disorder in PD, in the last years, studies using modern 3D motion analysis systems have further detailed the gait pattern in PD disclosing abnormalities in cadence, stance duration, swing duration, double support duration, leg length, step length, velocity, hip, knee and ankle ROMs. Such abnormal gait parameters seem to correlate with the clinical outcomes of UPDRS score, H-Y stage and milliequivalents of levodopa taken. Importantly, gait parameters can either normalize or improve after several rehabilitative treatment strategies including physiotherapy, assistive equipment, sensory cueing, treadmill training, physical activity, home base exercises. However, none of the previous studies specifically investigated which biomechanical factor can be modified after rehabilitation and which clinical characteristic can predict the rehabilitation-induced gait improvement. This would be extremely important to typifying, grouping and selecting patients, optimizing the rehabilitative strategies and cost management.
The aims of the present study were to evaluate in a sample of patients with PD: i) which gait parameters can be modified after a short-term rehabilitation program; ii) which, if any, clinical variable can predict the improvement of the gait function after rehabilitation. At this aim we quantitatively evaluated the gait performance of PD patients by means of a 3-D motion analysis system.
Read the detailed description
Fifty out of 67 patients with idiopathic PD assessed for eligibility were recruited at Rehabilitation Unit of Department of Medical and Surgical Sciences and Biotechnologies, University of Rome, Sapienza, and at Rehabilitation Unit of Policlinico Italia Centre, Rome, Italy. Patients were admitted for outpatient rehabilitation between May 2014 and April 2017. The inclusion criteria were a diagnosis of idiopathic PD according to UK bank criteria and Hoehn and Yahr stages 1 to 3. All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks. Exclusion criteria were: cognitive deficits (defined as scores of <26 on the Mini-Mental State Examination [MMSE]), moderate or severe depression (defined as scores of >17 on the Beck Depression Inventory [BDI]), and orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.
All participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase.
Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system.
The study complied with the Helsinki Declaration and received local ethics committee approval. Prior to taking part in the study, all the participants gave a written consent after a fully explanation of the experimental procedure.
- Conditions
- Parkinson Disease, Movement Disorders
- Being tested
- Rehabilitation program
- Keywords
- Parkinson disease, movement Disorders, gait disturbance, Parkinson, Parkinson gait, 3D motion analysis systems, motion analysis, Parkinson rehabilitation, rehabilitation gait improvement, gait improvement, SMART Capture, MATLAB software
- Medical subject headings
- Parkinson Disease, Movement Disorders, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
all patients received a rehabilitation program planned according to the European Physiotherapy guideline for Parkinson's disease and focus on:
- endurance, strength, flexibility and balance with functional practice for all H/Y stage
- endurance also for H/Y stage 1,
- motor learning principles and cue functional for H/Y stage 2-3
- external cues and self-instruction strategies and attention H/Y for stage 2-3 The rehabilitative program comprised 60-minute sessions a day (3d/wk).
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's disease | All participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase. Medication was kept constant throughout the trial, and all interventions were performed at the same time of day for each patient during ON phase.
Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system.
All patients received a rehabilitation program planned according to the European Physiotherapy guideline for Parkinson's disease Receives: Other: Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
stance duration (change)
time interval between two consecutive foot strikes of the same lower limb) expressed as a percentage of the stride duration
Measured: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
step length (change)
the distance measured from the heel print of one foot to the heel print of the other foot
Measured: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Step width (change)
Step width variability discriminates gait of healthy young and older adults during treadmill locomotion.
Measured: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
walking speed (change)
distance coverde by the body in unit of time
Measured: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
cadence (change)
time of steps per unit time
Measured: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
The flexion-extension hips (change)
Measured: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Trunk saggital plane (change)
Measured: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Trunk frotal plane (change)
Measured: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Secondary outcomes (2)
Unified Parkinson's Disease Rating Scale UPDRS Severity of parkinsonism
The UPDRS is made up of these sections:
- Part I: evaluation of mentation, behavior, and mood
- Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food
- Part III: clinician-scored monitored motor evaluation
- Part IV: complications of therapy
Measured: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Modified Hoehn and Yahr staging
- Unilateral involvement only usually with minimal or no functional disability Unilateral involvement only 1.5 - Unilateral and axial involvement
- Bilateral or midline involvement without impairment of balance Bilateral involvement without impairment of balance 2.5 - Mild bilateral disease with recovery on pull test
- Bilateral disease: mild to moderate disability with impaired postural reflexes; physically independent Mild to moderate bilateral disease; some postural instability; physically independent
- Severely disabling disease; still able to walk or stand unassisted Severe disability; still able to walk or stand unassisted
- Confinement to bed or wheelchair unless aided Wheelchair bound or bedridden unless aided
Measured: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study startMay 2014
- Primary completionApr 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariano Serrao, University of Roma La Sapienza
- Investigators
- Guido Caramanico, MD, Principal investigator, Università "La Sapienza di Roma"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336307
- Sponsor's protocol ID
- s001
- Status last verified
- Nov 2017
- First submitted
- 10 Oct 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meunier S, Pol S, Houeto JL, Vidailhet M. Abnormal reciprocal inhibition between antagonist muscles in Parkinson's disease. Brain. 2000 May;123 ( Pt 5):1017-26. doi: 10.1093/brain/123.5.1017.
PubMed 10775546Pistacchi M, Gioulis M, Sanson F, De Giovannini E, Filippi G, Rossetto F, Zambito Marsala S. Gait analysis and clinical correlations in early Parkinson's disease. Funct Neurol. 2017 Jan/Mar;32(1):28-34. doi: 10.11138/fneur/2017.32.1.028.
PubMed 28380321Vieregge P, Stolze H, Klein C, Heberlein I. Gait quantitation in Parkinson's disease--locomotor disability and correlation to clinical rating scales. J Neural Transm (Vienna). 1997;104(2-3):237-48. doi: 10.1007/BF01273184.
PubMed 9203085Pau M, Corona F, Pili R, Casula C, Sors F, Agostini T, Cossu G, Guicciardi M, Murgia M. Effects of Physical Rehabilitation Integrated with Rhythmic Auditory Stimulation on Spatio-Temporal and Kinematic Parameters of Gait in Parkinson's Disease. Front Neurol. 2016 Aug 11;7:126. doi: 10.3389/fneur.2016.00126. eCollection 2016.
PubMed 27563296Keus SH, Munneke M, Nijkrake MJ, Kwakkel G, Bloem BR. Physical therapy in Parkinson's disease: evolution and future challenges. Mov Disord. 2009 Jan 15;24(1):1-14. doi: 10.1002/mds.22141.
PubMed 18946880
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Gait Improvement in Patients With Parkinson's Disease After Rehabilitation
- ClinicalTrials.gov ID
- NCT03336307
- Acronym / sponsor ID
- s001
- Conditions
- Parkinson Disease, Movement Disorders
- Keywords
- Parkinson disease, movement Disorders, gait disturbance, Parkinson, Parkinson gait, 3D motion analysis systems, motion analysis, Parkinson rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 8 Nov 2017 (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.
Patients with Parkinson's disease show a gait disturbance which is considered as one of the most disabling aspect of the disease that strongly impacts on patients' autonomy and quality of life. The mechanism underlying gait impairment is multi-factorial, reflects the global motor impairment of patients with PD and is mainly related to a neurotransmitter deficiency inducing bradykinesia, rigidity, abnormal trunk control and postural instability. For this reason, and considering the impact of social and economic costs, one of the main foci of intervention in patients with PD should be treating gait abnormalities. This need is further reinforced by the knowledge that gait outcomes are correlated with longevity, cognitive decline and adverse events.
Besides the shorten-step gait clinical description of the gait disorder in PD, in the last years, studies using modern 3D motion analysis systems have further detailed the gait pattern in PD disclosing abnormalities in cadence, stance duration, swing duration, double support duration, leg length, step length, velocity, hip, knee and ankle ROMs. Such abnormal gait parameters seem to correlate with the clinical outcomes of UPDRS score, H-Y stage and milliequivalents of levodopa taken. Importantly, gait parameters can either normalize or improve after several rehabilitative treatment strategies including physiotherapy, assistive equipment, sensory cueing, treadmill training, physical activity, home base exercises. However, none of the previous studies specifically investigated which biomechanical factor can be modified after rehabilitation and which clinical characteristic can predict the rehabilitation-induced gait improvement. This would be extremely important to typifying, grouping and selecting patients, optimizing the rehabilitative strategies and cost management.
The aims of the present study were to evaluate in a sample of patients with PD: i) which gait parameters can be modified after a short-term rehabilitation program; ii) which, if any, clinical variable can predict the improvement of the gait function after rehabilitation. At this aim we quantitatively evaluated the gait performance of PD patients by means of a 3-D motion analysis system.
Detailed description
Fifty out of 67 patients with idiopathic PD assessed for eligibility were recruited at Rehabilitation Unit of Department of Medical and Surgical Sciences and Biotechnologies, University of Rome, Sapienza, and at Rehabilitation Unit of Policlinico Italia Centre, Rome, Italy. Patients were admitted for outpatient rehabilitation between May 2014 and April 2017. The inclusion criteria were a diagnosis of idiopathic PD according to UK bank criteria and Hoehn and Yahr stages 1 to 3. All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks. Exclusion criteria were: cognitive deficits (defined as scores of <26 on the Mini-Mental State Examination [MMSE]), moderate or severe depression (defined as scores of >17 on the Beck Depression Inventory [BDI]), and orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.
All participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase.
Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system.
The study complied with the Helsinki Declaration and received local ethics committee approval. Prior to taking part in the study, all the participants gave a written consent after a fully explanation of the experimental procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's disease | – | Other: Rehabilitation programAll participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase. Medication was kept constant throughout the trial, and all interventions were performed at the same time of day for each patient during ON phase. Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system. All patients received a rehabilitation program planned according to the European Physiotherapy guideline for Parkinson's disease |
Who may qualify
- Ages
- 48 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty out of 67 patients with idiopathic PD assessed for eligibility were recruited at Rehabilitation Unit of Department of Medical and Surgical Sciences and Biotechnologies, University of Rome, Sapienza, and at Rehabilitation Unit of Policlinico Italia Centre, Rome, Italy. Patients were admitted for outpatient rehabilitation between May 2014 and April 2017. All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks. All participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase. Patients' clinical and anthropometric characteristics. Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system.
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic PD according to UK bank criteria
- Hoehn and Yahr stages 1 to 3.
- All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks
Key exclusion criteria (2 listed)
- Cognitive deficits (defined as scores of <26 on the Mini-Mental State Examination [MMSE]),
- moderate or severe depression (defined as scores of >17 on the Beck Depression Inventory [BDI]), -. orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.
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 |
|---|---|---|
| Rehabilitation programall patients received a rehabilitation program planned according to the European Physiotherapy guideline for Parkinson's disease and focus on: * endurance, strength, flexibility and balance with functional practice for all H/Y stage * endurance also for H/Y stage 1, * motor learning principles and cue functional for H/Y stage 2-3 * external cues and self-instruction strategies and attention H/Y for stage 2-3 The rehabilitative program comprised 60-minute sessions a day (3d/wk). | Other | Patients with Parkinson's disease |
Primary outcome
stance duration (change)
Time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
time interval between two consecutive foot strikes of the same lower limb) expressed as a percentage of the stride duration
step length (change)
Time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
the distance measured from the heel print of one foot to the heel print of the other foot
Step width (change)
Time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Step width variability discriminates gait of healthy young and older adults during treadmill locomotion.
walking speed (change)
Time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
distance coverde by the body in unit of time
cadence (change)
Time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
time of steps per unit time
The flexion-extension hips (change)
Time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Trunk saggital plane (change)
Time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Trunk frotal plane (change)
Time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
2 secondary outcomes
Unified Parkinson's Disease Rating Scale UPDRS Severity of parkinsonism
Time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Modified Hoehn and Yahr staging
Time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Background: PubMed 10775546Meunier S, Pol S, Houeto JL, Vidailhet M. Abnormal reciprocal inhibition between antagonist muscles in Parkinson's disease. Brain. 2000 May;123 ( Pt 5):1017-26. doi: 10.1093/brain/123.5.1017.
- Background: PubMed 28380321Pistacchi M, Gioulis M, Sanson F, De Giovannini E, Filippi G, Rossetto F, Zambito Marsala S. Gait analysis and clinical correlations in early Parkinson's disease. Funct Neurol. 2017 Jan/Mar;32(1):28-34. doi: 10.11138/fneur/2017.32.1.028.
- Background: PubMed 9203085Vieregge P, Stolze H, Klein C, Heberlein I. Gait quantitation in Parkinson's disease--locomotor disability and correlation to clinical rating scales. J Neural Transm (Vienna). 1997;104(2-3):237-48. doi: 10.1007/BF01273184.
- Background: PubMed 27563296Pau M, Corona F, Pili R, Casula C, Sors F, Agostini T, Cossu G, Guicciardi M, Murgia M. Effects of Physical Rehabilitation Integrated with Rhythmic Auditory Stimulation on Spatio-Temporal and Kinematic Parameters of Gait in Parkinson's Disease. Front Neurol. 2016 Aug 11;7:126. doi: 10.3389/fneur.2016.00126. eCollection 2016.
- Background: PubMed 18946880Keus SH, Munneke M, Nijkrake MJ, Kwakkel G, Bloem BR. Physical therapy in Parkinson's disease: evolution and future challenges. Mov Disord. 2009 Jan 15;24(1):1-14. doi: 10.1002/mds.22141.
- Individual participant dataSharing planned: No
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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.
Guido Caramanico, MD principal investigator
Università "La Sapienza di Roma"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Movement Disorders, run by University of Roma La Sapienza at 1 site in Italy.
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 3 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 8 Nov 2017. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
stance duration (change) (time frame: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03336307, which also lists 5 linked publications.
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 8 Nov 2017.