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ClinicalTrials.gov ID

NCT04097080

Lead Sponsor

Nobilis Therapeutics Inc.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 1

Enrollment

60Estimated

Last Update Posted

Mar 3, 2021Actual

Start Date

Dec 15, 2019Actual

Primary Completion Date

Nov 2021Estimated

Completion Date

Dec 2021Estimated

Official Title

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

Brief Summary

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).

• Parkinson Disease

• NBTX-001
• Standard of Care

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Nobilis Therapeutics Inc.INDUSTRY

moniki-nevrol@mail.ru7(495)6845763