Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 6:40 AM
Study NCT ID:
NCT04592159
Status:
WITHDRAWN
Last Update Posted:
2022-06-03
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress Disorder
Sponsor:
Jazz Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress Disorder
Status:
WITHDRAWN
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The decision to suspend this study was based upon evaluation of pandemic-related challenges impacting both clinical trial sites and potential participants. This suspension was initiated prior to site activation and participant recruitment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be conducted to evaluate the efficacy of nabiximols for the treatment of symptoms of post-traumatic stress disorder (PTSD) in participants receiving selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) pharmacotherapy.
Detailed Description:
This multicenter, randomized, double-blind, placebo-controlled, parallel-group trial includes a screening period of up to 28 days, an 8-week treatment period (comprising a 2-week titration phase and a 6-week maintenance phase), and a 2-week follow-up period.
At screening (Visit 1), all participants will receive instructions on how to complete a writing exercise (Exposure Writing Exercise) related to their traumatic experience. Prior to the baseline visit (Visit 2), participants must complete an approximate 30-minute writing exercise outside of the trial site and should have re-read the write up at least once to be eligible for enrollment.
Throughout the screening and treatment periods, the dose of SSRI/SNRI used as background therapy, if any, should remain unchanged. On Day 1, eligible participants will be randomly assigned to either nabiximols or placebo in a 1:1 ratio.
Participants will be advised to titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose that relieves their most bothersome symptom of PTSD or to a maximum of 12 sprays/day over the first 14 days of treatment. Participants should continue at the same dose level achieved at the end of the titration phase ±1 spray divided into a morning dose and an evening dose for the remainder of the treatment period.
Health-related quality of life, safety, and tolerability will be evaluated during the treatment period.
Participants who complete the trial will participate for a total of approximately 14 weeks (99 days), including the 28-day Screening period.
At screening (Visit 1), all participants will receive instructions on how to complete a writing exercise (Exposure Writing Exercise) related to their traumatic experience. Prior to the baseline visit (Visit 2), participants must complete an approximate 30-minute writing exercise outside of the trial site and should have re-read the write up at least once to be eligible for enrollment.
Throughout the screening and treatment periods, the dose of SSRI/SNRI used as background therapy, if any, should remain unchanged. On Day 1, eligible participants will be randomly assigned to either nabiximols or placebo in a 1:1 ratio.
Participants will be advised to titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose that relieves their most bothersome symptom of PTSD or to a maximum of 12 sprays/day over the first 14 days of treatment. Participants should continue at the same dose level achieved at the end of the titration phase ±1 spray divided into a morning dose and an evening dose for the remainder of the treatment period.
Health-related quality of life, safety, and tolerability will be evaluated during the treatment period.
Participants who complete the trial will participate for a total of approximately 14 weeks (99 days), including the 28-day Screening period.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-000527-39 | EUDRACT_NUMBER | None | View |