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

NCT04097080 | Unknown Phase 1

• 1 other identifier: NBTX-009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NBTX-001

EXPERIMENTAL

30% medical grade xenon/70% Oxygen

Drug: NBTX-001

Standard of Care

PLACEBO COMPARATOR

Reconstituted air

Drug: Standard of Care

Interventions

NBTX-001 DRUG

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

NBTX-001

Standard of Care DRUG

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nobilis Therapeutics Inc.: lead

Study Sites (2)

Institute of Addictology

Moscow, 129110, Russia

RECRUITING

MONIKI

Moscow, 129110, Russia

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Vlad Bogin, MD, FACP

CONTACT

971-229-1679; vlad.bogin@nobilistx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: December 15, 2019
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

RU (2)