Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

• Sponsor: Nobilis Therapeutics Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03635827
• Collaborator: (none)
• Enrollment: 190
• Arms: 2
• Anticipated Duration (Days): 30

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Combination Product: NBTX-001 Xenon Inhaler; Combination Product: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Posttraumatic Stress Disorder
• Anticipated Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NBTX-001	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.
Placebo Comparator: Placebo	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.

Outcome Measures

Primary Outcome Measures

1. CAPS-5 [Baseline to Week 6]

   Change in CAPS-5 score

Secondary Outcome Measures

1. PCL-5 [Baseline to Week 6]

   Change in PCL-5 score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nobilis Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nobilis Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT03635827
• Other Study ID Numbers: NBTX-001
• First Posted: Aug 17, 2018
• Last Update Posted: Mar 3, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Xenon

Study Results

No Results Posted as of Mar 3, 2021