Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT04097080 |
Recruitment Status :
Recruiting
First Posted : September 20, 2019
Last Update Posted : March 2, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Drug: NBTX-001 Drug: Standard of Care | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease |
Actual Study Start Date : | December 15, 2019 |
Estimated Primary Completion Date : | November 2021 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: NBTX-001
30% medical grade xenon/70% Oxygen
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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
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Drug: Standard of Care
Placebo group will receive reconstituted air given three times a week. |
- Unified Parkinson Disease Rating Scale (UPDRS) [ Time Frame: 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097080
Contact: Vlad Bogin, MD, FACP | 971-229-1679 | vlad.bogin@nobilistx.com |
Russian Federation | |
Institute of Addictology | Recruiting |
Moscow, Russian Federation, 129110 | |
Contact: Alexander Dobrovolsky, MD 7(925)5173999 dobdocps@yandex.ru | |
Principal Investigator: Alexander Dobrovolsky, MD | |
MONIKI | Recruiting |
Moscow, Russian Federation, 129110 | |
Contact: Rinat Bogdanov, MD 7(495)6845763 moniki-nevrol@mail.ru | |
Principal Investigator: Rinat Bogdanov, MD |
Responsible Party: | Nobilis Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT04097080 |
Other Study ID Numbers: |
NBTX-009 |
First Posted: | September 20, 2019 Key Record Dates |
Last Update Posted: | March 2, 2020 |
Last Verified: | February 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |