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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097080
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Nobilis Therapeutics Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: NBTX-001 Drug: Standard of Care Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Xenon

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Vlad Bogin, MD, FACP 971-229-1679 vlad.bogin@nobilistx.com

Locations
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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         
Sponsors and Collaborators
Nobilis Therapeutics Inc.
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases