Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Nobilis Therapeutics Inc.
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Unified Parkinson Disease Rating Scale (UPDRS)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient must be male or female over the age of
- •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
Arms & Interventions
NBTX-001
30% medical grade xenon/70% Oxygen
Intervention: NBTX-001 (Drug)
Standard of Care
Reconstituted air
Intervention: Standard of Care (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported