Parkinson DiseasePhase 1NCT04097080
Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease
A Phase 1 study testing NBTX-001 in people with Parkinson Disease, run by Nobilis Therapeutics Inc. at 2 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- NBTX-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesRussia
- Study dates
- 15 Dec 2019to Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Institute of Addictology
Moscow, 129110
Alexander Dobrovolsky, MD, 7(925)5173999, dobdocps@yandex.ru
Alexander Dobrovolsky, MD
- Recruiting
MONIKI
Moscow, 129110
Rinat Bogdanov, MD, 7(495)6845763, moniki-nevrol@mail.ru
Rinat Bogdanov, MD
About this study
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).
- Conditions
- Parkinson Disease
- Being tested
- NBTX-001, Standard of Care
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBTX-001Drug
Active drug group will receive 6 doses of NBTX-001 given three times a week.
Standard of CareDrug
Placebo group will receive reconstituted air given three times a week.
| Study group | Role | What they receive |
|---|---|---|
| NBTX-001 | Experimental | 30% medical grade xenon/70% Oxygen Receives: Drug: NBTX-001 |
| Standard of Care | Placebo comparator | Reconstituted air Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start15 Dec 2019
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nobilis Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097080
- Sponsor's protocol ID
- NBTX-009
- Status last verified
- Mar 2021
- First submitted
- 18 Sep 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04097080
- Acronym / sponsor ID
- NBTX-009
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nobilis Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBTX-001 | Experimental | Drug: NBTX-00130% medical grade xenon/70% Oxygen |
| Standard of Care | Placebo comparator | Drug: Standard of CareReconstituted air |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBTX-001Active drug group will receive 6 doses of NBTX-001 given three times a week. | Drug | NBTX-001 |
| Standard of CarePlacebo group will receive reconstituted air given three times a week. | Drug | Standard of Care |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NBTX-001 in people with Parkinson Disease, run by Nobilis Therapeutics Inc. at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vlad Bogin, MD, FACP (971-229-1679, vlad.bogin@nobilistx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson Disease Rating Scale (UPDRS) (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.