Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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This study evaluates the hypothesis that the gas mixture with xenon will have a positive effect on the symptoms in patients with Parkinson's Disease. The study will test the hypothesis that the gas mixture with xenon has a symptomatic treatment potential for patients with Parkinson's Disease, as measured by change from baseline in the Unified Parkinson Disease Rating Scale (UPDRS).

Official Title
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Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: NBTX-001
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be male or female over the age of 18. The subject must have idiopathic Parkinson's disease. The subject has Stage III by Hoehn and Yahr in the on state on a screening visit Subjects suffering from anxiety, depression, cognitive dysfunction Dopaminergic drugs should be taken in a stable dosage for 28 days prior to registration, and throughout the study Patients who have signed an approved consent form and are consistent with both the clinical trial plan and follow-up. Exclusion Criteria: Patients have atypical parkinsonism (eg, neuroleptics, metoclopramide, flunarizin), metabolic neurodegenerative disorders (eg, Wilson's disease), encephalitis, cerebrovascular disease or degenerative disease (e.g. progressive supranuclear palsy) Patients who received deep brain stimulation Patients with cancer, HIV, kidney or liver disease. Patients taking new antipsychotic, antidepressant, anxiolytic or narcotic drugs for less than 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBTX-001<br>30% medical grade xenon/70% Oxygen | Drug: NBTX-001<br>* Active drug group will receive 6 doses of NBTX-001 given three times a week.<br>|
| Placebo Comparator: Standard of Care<br>Reconstituted air | Drug: Standard of Care<br>* Placebo group will receive reconstituted air given three times a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson Disease Rating Scale (UPDRS) | Analysis of Unified Parkinson Disease Rating Scale (UPDRS) from baseline.The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The UPDRS scale includes series of ratings for typical Parkinson's symptoms that cover all of the movement hindrances of Parkinson's disease. The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale. Each answer to the scale is evaluated by a medical professional that specializes in Parkinson's disease during patient interviews. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability). | Baseline to Week 24 |