Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis (RELEASE MSS3)
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|ClinicalTrials.gov Identifier: NCT04203498|
Recruitment Status : Recruiting
First Posted : December 18, 2019
Last Update Posted : February 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis (MS)||Drug: Nabiximols Drug: Placebo||Phase 3|
This multicenter, double-blind, placebo-controlled trial includes a 28-day Baseline period, a 12-week treatment period (comprising a 2-week titration phase and a 10-week maintenance phase), and 2-week follow-up period.
Eligible participants will enter the 28-day baseline period. During baseline, participants will maintain their optimized oral MS antispasticity medication regimen and record spasm count using an electronic daily diary. At screening (Day 1), eligible participants will be randomized 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 or to a maximum of 12 sprays/day over the first 14 days of treatment. Participants may leave a gap between sprays of approximately 15 minutes. 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.
Daily spasm count, the participant's symptom experiences, clinician's assessment of spasticity, functional outcomes, health-related quality of life, changes in mood, safety, tolerability, and pharmacokinetics will be evaluated during the treatment period.
Participants who complete the trial will participate for a total of approximately 18 weeks (127 days), including the 28-day baseline period. Participants will have a maximum duration of 85 (±7) days on IMP treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||446 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients With Spasticity Due to Multiple Sclerosis|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||February 1, 2023|
Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides.Nabiximols will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|Placebo Comparator: Placebo||
Placebo to match nabiximols will be presented as an oromucosal spray containing the excipients ethanol and propylene glycol (50% v/v) with colorings and flavored with peppermint oil (0.05% v/v). Each spray will deliver 100 microliters (μL) containing no active ingredients. Placebo will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
- Change from Baseline in the Average Daily Spasm Count (from Days 57 to 84 Compared to the Average Daily Spasm Count for the Baseline Period) [ Time Frame: Baseline, Day 84 ]
- Change From Baseline in The Multiple Sclerosis Spasticity Scale (MSSS-88) Total Score at Day 85 [ Time Frame: Baseline, Day 85 ]
- Number of Participants with Treatment-emergent Adverse Events [ Time Frame: Baseline through Day 99 ]
- Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Test Values at Days 29 and 85 [ Time Frame: Baseline, Days 29 and 85 ]
- Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Values at Days 15, 29, 57, 85, and 99 [ Time Frame: Baseline, Days 15, 29, 57, 85, and 99 ]
- Number of Participants with Clinically Significant Changes from Baseline in Physical Examination Values at Day 85 [ Time Frame: Baseline, Day 85 ]
- Number of Participants with Clinically Significant Changes from Baseline in 12-lead Electrocardiogram (ECG) Values at Days 29 and 85 [ Time Frame: Baseline, Days 29 and 85 ]
- Mean Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Days 15, 29, 57, and 85 [ Time Frame: Days 15, 29, 57, and 85 ]
- Plasma Concentrations for Tetrahydrocannabinol (THC), Cannabidiol (CBD), and Relevant Metabolites at Days 1 (Predose), 15, 29, 57, and 85 [ Time Frame: Days 1, 15, 29, 57, and 85 ]Sparse pharmacokinetic (PK) sampling option, blood samples will be taken as follows: Day 1, predose; Days 15, 29, 57, and 85, any time during the visit. Semi-intensive PK sampling option, blood samples will be taken as follows: Day 1, predose. At 1 visit (either Days 15, 29, or 57, 1 sample predose (i.e., prior to administration of investigational medicainal product [IMP] at the investigational site), 1 sample between 2 and 3 hours postdose, 1 sample between 4 and 6 hours postdose, and 1 sample between 6 and 8 hours postdose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203498
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