PD002J

Phase 3

• Conditions: Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease

• Registration Number: JPRN-jRCTs032180186
• Lead Sponsor: KAMEI TETSUMASA

Brief Summary

Adverse events were confirmed as mild and moderate symptoms, but no serious.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-05
• Study Completion: 2020-11-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3

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 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.

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. These include: multisystem atrophy, progressive supranuclear palsy,
corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
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 < 24 on the MMSE(Mini-Mental State Examination) or Mattis Dementia Rating Scale of 120 or lower.
6.Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation. Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 60 days prior to study entry and if deemed appropriately managed by the site neuropsychologist.
7.Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist. Significant depression is being defined quantitatively as a score of greater than 14 on the Beck Depression Inventory.
8.Legal incapacity or limited legal capacity as determined by the neuropsychologist.
9.Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within the preceding 12 month period:
a.Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household).
b.Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use) .
c.Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct) .
d.Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
10.Subjects with unstable cardiac status including:
a.Unstable angina pectoris on medication.
b.Subjects with documented myocardial infarction within six months of protocol entry.
c.Significant congestive heart failure defined with ejection fraction < 40 .
d.Subjects with unstable ventricular arrhythmias .
e.Subjects with atrial arrhythmias that are not rate-controlled.
11.Severe hypertension (diastolic BP > 100 on medication) .
12.Current medical condition resulting in abnormal bleeding and/or coagulopathy.
13.Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure.
14.Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard.
15.Patient with severely impaired renal function with estimated glomerular filtration rate <30

Study & Design

• Study Type: Interventional
• Study Design: Not specified