Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656806
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Single Center Study to Evaluate the Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALM
Brief Summary:
The goal of this clinical trial is to learn if inhaled drug NC-107 works to treat Generalized anxiety disorder in adults It will also learn about the safety of the drug NC-107 The main questions it aims to answer are
Does the inhaled drug NC-107 decrease the severity of anxiety in participants What medical problems could participants have when taking drug NC-107 How quickly does NC-107 absorb and get into the blood stream Researchers will compare drug NC-107 to a placebo a look-alike substance that contains no drug to see how effective NC-107 in treating generalized anxiety disorder
Participants will be equal to or above 18 years of age and sign an informed consent They will answer two questionnaires about anxiety and have vitals taken as well as blood drawn for laboratory results If a questionnaire reveals moderate anxiety and all blood work is normal the patient will enter the study The patient will be instructed on the use of an inhaler that will deliver the medication via the lung Two puffs twice daily of NC-107 or placebo will be used during the remainder of the study
Blood will be drawn for peak and trough levels of NC-107 Questionnaires will be completed at each visit
Does the inhaled drug NC-107 decrease the severity of anxiety in participants What medical problems could participants have when taking drug NC-107 How quickly does NC-107 absorb and get into the blood stream Researchers will compare drug NC-107 to a placebo a look-alike substance that contains no drug to see how effective NC-107 in treating generalized anxiety disorder
Participants will be equal to or above 18 years of age and sign an informed consent They will answer two questionnaires about anxiety and have vitals taken as well as blood drawn for laboratory results If a questionnaire reveals moderate anxiety and all blood work is normal the patient will enter the study The patient will be instructed on the use of an inhaler that will deliver the medication via the lung Two puffs twice daily of NC-107 or placebo will be used during the remainder of the study
Blood will be drawn for peak and trough levels of NC-107 Questionnaires will be completed at each visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None