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

Primary Purpose

Parkinson Disease

Status

Unknown status

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

NBTX-001

Standard of Care

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institute of AddictologyRecruiting
MONIKIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NBTX-001

Standard of Care

Arm Description

30% medical grade xenon/70% Oxygen

Reconstituted air

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT04097080

First Posted

September 18, 2019

Last Updated

March 2, 2021

Sponsor

Nobilis Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04097080

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 15, 2019 (Actual)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nobilis Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NBTX-001

Arm Type

Experimental

Arm Description

30% medical grade xenon/70% Oxygen

Arm Title

Standard of Care

Arm Type

Placebo Comparator

Arm Description

Reconstituted air

Intervention Type

Drug

Intervention Name(s)

NBTX-001

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Standard of Care

Intervention Description

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

Primary Outcome Measure Information:

Title

Unified Parkinson Disease Rating Scale (UPDRS)

Description

Time Frame

Baseline to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vlad Bogin, MD, FACP

Phone

971-229-1679

vlad.bogin@nobilistx.com

Facility Information:

Facility Name

Institute of Addictology

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander Dobrovolsky, MD

Phone

7(925)5173999

dobdocps@yandex.ru

First Name & Middle Initial & Last Name & Degree

Alexander Dobrovolsky, MD

Facility Name

MONIKI

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rinat Bogdanov, MD

Phone

7(495)6845763

moniki-nevrol@mail.ru

First Name & Middle Initial & Last Name & Degree

Rinat Bogdanov, MD

12. IPD Sharing Statement

Learn more about this trial

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

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