Xenon Inhalation for Treatment of Panic Disorder | NCT04432155

Studies
Xenon Inhalation for Treatment of Panic Disorder

NCT04432155

Sponsor

Nobilis Therapeutics Inc.

Status

Unknown status

Last Update Posted

Mar 3, 2021Actual

Enrollment

200Estimated

Phase

Phase 2Phase 3

Conditions

Panic Disorder

Interventions

Xenon
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2021Estimated

Primary Completion Date

Nov 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Jun 11, 2020

First Submission Date that Met QC Criteria

Jun 11, 2020

First Posted Date

Jun 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2021

Last Update Posted Date

Mar 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with panic disorder.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NBTX-001	Experimental	Combination Product: NBTX-001 Xenon Inhaler The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.	Drug: Xenon
Placebo	Placebo Comparator	Combination Product: Placebo The placebo medical gas consists of 30% oxygen and 70% nitrogen. The dose of placebo medical gas is 10 L by volume.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xenon	Drug	30% xenon, 30% oxygen, and 40% nitrogen	NBTX-001
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PDSS	Panic Disorder Severity Scale	Baseline to Week 6

Secondary Outcomes

Measure	Description	Time Frame
PHQ-9	Patient Health Questionnaire-9	Baseline to Week 6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary diagnosis of panic disorder according to DSM-5.
Male and female patients ≥18 years of age.

Exclusion Criteria:

History of schizophrenia, bipolar and other psychotic disorders.
Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma, severe lung disease and/or baseline oxygen saturations <92% or any other respiratory conditions / diseases that may affect the respiratory function.
Currently undergoing targeted empirically-driven psychotherapy for panic disorder or panic disorder-related symptoms.
Currently undergoing exposure-based psychotherapy for any condition.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016584	Panic Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014978	Xenon

Ancestor Terms

ID	Term
D005741	Noble Gases
D004602	Elements
D007287	Inorganic Chemicals
D005740	Gases

Browse Leaves

Not provided

Browse Branches

Not provided