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

Nobilis Therapeutics

Status and phase: Unknown; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: NBTX-001; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04097080

NBTX-009

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

NBTX-001

Experimental group

Description:

30% medical grade xenon/70% Oxygen

Treatment:

Drug: NBTX-001

Standard of Care

Placebo Comparator group

Description:

Reconstituted air

Treatment:

Drug: Standard of Care