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

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).

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: NBTX-001; Drug: Standard of Care

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Vlad Bogin, MD, FACP; Phone Number: 971-229-1679; Email: vlad.bogin@nobilistx.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 129110
    • Recruiting
    • Institute of Addictology
    • Contact: Alexander Dobrovolsky, MD; Phone Number: 7(925)5173999; Email: dobdocps@yandex.ru
    • Principal Investigator: Alexander Dobrovolsky, MD
  • Moscow, Russian Federation, 129110
    • Recruiting
    • MONIKI
    • Contact: Rinat Bogdanov, MD; Phone Number: 7(495)6845763; Email: moniki-nevrol@mail.ru
    • Principal Investigator: Rinat Bogdanov, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nobilis Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NBTX-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No