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

Phase 1

• Conditions: Parkinson Disease
• Interventions: Drug: NBTX-001; Drug: Standard of Care

• Registration Number: NCT04097080
• Lead Sponsor: Nobilis Therapeutics Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Study Start: 2019-12-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBTX-001	NBTX-001	30% medical grade xenon/70% Oxygen
Standard of Care	Standard of Care	Reconstituted air

Primary Outcome Measures

Name	Time	Method
Unified Parkinson Disease Rating Scale (UPDRS)	Baseline to Week 24	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).

Trial Locations

Locations (2)

Institute of Addictology; 🇷🇺 Moscow, Russian Federation

MONIKI; 🇷🇺 Moscow, Russian Federation