Viewing Study NCT05974293



Ignite Creation Date: 2024-05-06 @ 7:19 PM
Last Modification Date: 2024-10-26 @ 3:04 PM
Study NCT ID: NCT05974293
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-11-18
First Post: 2023-07-26

Brief Title: A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders
Sponsor: Michael Levy MDPhD
Organization: Massachusetts General Hospital

Study Overview

Official Title: A Phase IIb Study of the Safety and Efficacy of Nabiximols in Subjects With Spasticity Due to Neuromyelitis Optica Spectrum Disorders A Double-blind Randomized Placebo-Controlled Crossover Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SENS-NMO
Brief Summary: The goal of this clinical trial is to evaluate the safety and efficacy of nabiximols a cannabinoid spray for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and antibody-negative NMOSD The main question it aims to answer is whether treatment with nabiximols improves patient-reported spasticity ratings compared to treatment with a placebo This trial will also answer whether nabiximols impact pain spasm frequency mood walking ability and sleep Participants will be mailed the treatments and placebo treatments and will be asked to complete study visits and questionnaires remotely There is also an optional sub-study that involves in-person visits with ultrasound imaging and in-person neurologic exams
Detailed Description: Patients with NMOSD often have medication-resistant and severe spasticity due to longitudinally extensive spinal cord lesions Existing treatments are limited by their efficacy and tolerability Cannabinoids have been shown to quantitatively improve spasticity in mouse models of neuroinflammation and nabiximols a cannabinoid-based oromucosal spray have demonstrated efficacy for medication-resistant spasticity in multiple sclerosis However no studies have as yet explored the use of nabiximols specifically in NMOSD and there is a significant unmet need for new symptomatic treatments in this patient population The goal of this study is to evaluate the safety and efficacy of nabiximols spray for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and seronegative NMOSD This study is designed as a phase IIb single-site double-blind randomized placebo-controlled 2x2 crossover clinical trial with a 2-week washout period between treatment periods After randomization each participant enters into Period 1 which begins with a 2-week dose escalation period with a pre-defined dose escalation scheme followed by a 4-week stable treatment period After completion of Period 1 all participants have a 2-week washout period and then enter Period 2 where they again complete a 2-week dose escalation period and 4-week constant treatment period The patient-reported 0-10 numeric rating scale for spasticity NRS-S is the primary outcome measure All key study procedures are performed virtually including a weekly electronic study diary additional weekly surveys and 8 virtual video-based study visits including a screening visit and safety follow up visit Additional optional in-person assessments of spasticity neurologic exam modified Ashworth Scale and muscle ultrasound elastography will be performed for a selection of local participants In total the study has a 20-week duration per participant from the screening visit to the final study completion for safety follow-up visit including 12 weeks of on-treatment time

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None