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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2021-12-31

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).

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NBTX-001

30% medical grade xenon/70% Oxygen

Group Type EXPERIMENTAL

NBTX-001

Intervention Type DRUG

Active drug group will receive 6 doses of NBTX-001 given three times a week.

Standard of Care

Reconstituted air

Group Type PLACEBO_COMPARATOR

Standard of Care

Intervention Type DRUG

Placebo group will receive reconstituted air given three times a week.

Interventions

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NBTX-001

Active drug group will receive 6 doses of NBTX-001 given three times a week.

Intervention Type DRUG

Standard of Care

Placebo group will receive reconstituted air given three times a week.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No