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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033955
Receipt No. R000038714
Scientific Title A Feasibility Clinical Trial of the Management of the Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Transcranial System
Date of disclosure of the study information 2018/09/01
Last modified on 2018/08/30

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Basic information
Public title A Feasibility Clinical Trial of the Management of the Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Transcranial System
Acronym PD002J
Scientific Title A Feasibility Clinical Trial of the Management of the Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Transcranial System
Scientific Title:Acronym PD002J
Region
Japan

Condition
Condition Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The proposed study will evaluate the safety, and initial efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications in subjects who are over 20 years of age and considered medication refractory with advanced idiopathic Parkinsons disease .
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes The proposed study will evaluate the safety, and initial efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The proposed study will evaluate the safety, and initial efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications and considered medication refractory with advanced idiopathic Parkinsons disease.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Men and women, age 20 years and older
2. Subjects who are able and willing to give informed consent and able to attend all study visits through 24 Months
3. Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site
4. Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
5. MDS UPDRS score of 30 in the meds OFF condition
6. Disabling motor complications of PD on optimum medical treatment characterized dyskinesia or motor fluctuations (MDS-UPDRS item 4.2 score of 2 or 3 in the meds ON condition)
7. Predominant disability from one side of the body.
8. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry.
9. Subject is able to communicate sensations during the ExAblate Neuro procedure.
Key exclusion criteria 1. Hoehn and Yahr stage in the on medication state of 3 or greater
2. Presence of other central neurodegenerative disease suspected on neurological examination.
3. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
4. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
5. Presence of significant cognitive impairment defined as score 21 Unstable psychiatric disease,
6. Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist.
7. Subjects exhibiting any behavior consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM 4 .
8. 9.Subjects with unstable cardiac status including.
10.Severe hypertension
11.Current medical condition resulting in abnormal bleeding and or coagulopathy
12.Receiving anticoagulant
13. Subjects with risk factors for intraoperative or postoperative bleeding as indicated
14. Patient with severely impaired renal function with estimated glomerular filtration rate
15. Subjects with standard contraindications for MR imaging
16. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
17. History of intracranial hemorrhage
18. History of multiple strokes, or a stroke within past 6 months
19. Subjects with a history of seizures within the past year
20. Subjects with brain tumors
21. Subjects with intracranial aneurysms requiring treatment or arterial venous malformations requiring treatment.
22. Pregnancy or lactation.
23. All patients with severe premorbid risks3 4 MDS UPDRS Part1 2
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsumasa Kamei
Organization Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Division name neurology department
Zip code
Address 1-5-1,Kandai,Tsujido,Fujisawa,Kanagawa
TEL 0466-35-1177
Email tetsumasakam@ctmc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Etsuko Shimizu
Organization Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Division name Clinical Research Center
Zip code
Address 1-5-1,Kandai,Tsujido,Fujisawa,Kanagawa
TEL 0466-35-1177
Homepage URL
Email shimizu@mirai-iryo.com

Sponsor
Institute Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Institute
Department

Funding Source
Organization InSightec
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 19 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 30 Day
Last modified on
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038714

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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