Xenon Inhalation for Treatment of Posttraumatic Stress Di... | NCT03635827

Studies
Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

NCT03635827

Sponsor

Nobilis Therapeutics Inc.

Status

Unknown status

Last Update Posted

Mar 3, 2021Actual

Enrollment

190Estimated

Phase

Phase 2Phase 3

Conditions

Post Traumatic Stress Disorder

Interventions

NBTX-001 Xenon Inhaler
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

Jun 2021Estimated

Completion Date

Jul 2021Estimated

First Submitted Date

Aug 15, 2018

First Submission Date that Met QC Criteria

Aug 15, 2018

First Posted Date

Aug 17, 2018Actual

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 PTSD.

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

190Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NBTX-001	Active Comparator		Combination Product: NBTX-001 Xenon Inhaler
Placebo	Placebo Comparator		Combination Product: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NBTX-001 Xenon Inhaler	Combination Product	The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.	NBTX-001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CAPS-5	Change in CAPS-5 score	Baseline to Week 6

Secondary Outcomes

Measure	Description	Time Frame
PCL-5	Change in PCL-5 score	Baseline to Week 6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a current diagnosis of PTSD (documented diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria and a Clinician Administered PTSD Scale [CAPS-5] total severity score of >30).
Male and female patients between the ages of 18 and 85 years.

Exclusion Criteria:

History of schizophrenia, bipolar and other psychotic disorders.
Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma or any other respiratory conditions / diseases that may affect the respiratory function.
Currently undergoing PTSD-targeted psychotherapy.
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

85 Years

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
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided