Multiple Sclerosis (MS) Clinical Trial
— RELEASE MSS3Official 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
Verified date | March 2023 |
Source | Jazz Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is being conducted to demonstrate the efficacy of nabiximols, compared with placebo, when added to standard of care, in the treatment of muscle spasms associated with multiple sclerosis (MS).
Status | Terminated |
Enrollment | 238 |
Est. completion date | February 27, 2023 |
Est. primary completion date | February 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Criteria at screening: 1. Participant is male or female aged 18 years or above. 2. Participant has had a diagnosis with any disease subtype of multiple sclerosis (MS), by revised 2017 McDonald criteria, for at least 12 months prior to screening and is expected to remain stable for the duration of the trial. 3. Participant has had treatment with at least 1 optimized oral antispasticity therapy prior to Visit 1 that must include either oral baclofen or oral tizanidine (monotherapy or combination therapy). 4. Participant is currently receiving optimized treatment with at least 1 oral antispasticity medication (baclofen, tizanidine, and/or dantrolene) and has been stable for at least 30 days prior to screening. 5. If the participant is currently receiving an approved MS disease-modifying therapy, it must be at a stable dose for at least 3 months prior to screening and is expected to remain stable for the duration of the trial. Exclusion Criteria: 1. Participant has any concomitant disease or disorder that has spasticity-like symptoms or that may influence the participant's level of spasticity. 2. Participant has had a relapse of MS within the 60 days prior to screening (Visit 1). 3. Participant is currently using or has used cannabis or a cannabinoid-derived product for medicinal or recreational use (within 30 days of screening) and is unwilling to abstain for the duration of the trial. 4. Participant is currently using botulinum toxin injection for the relief of spasticity (within 6 months of screening) and is unwilling to abstain for the duration of the trial. 5. Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP. 6. Participant is male and fertile unless willing to ensure that he uses male contraception or remains sexually abstinent during the trial and for 3 months thereafter. 7. Participant is female and of childbearing potential unless willing to ensure that she uses a highly effective method of birth control during the trial and for 3 months thereafter. 8. Participant is female and pregnant, lactating, or planning pregnancy during the course of the trial or within 3 months thereafter. 9. Participant has received an IMP within the 30 days prior to screening. 10. Participant has a history of severe psychiatric disorder that may be exacerbated by the use of a cannabinoid-containing product. 11. Participant has any known or suspected history of alcohol or substance abuse (including opiate abuse) or dependence within 1 year prior to screening. 12. Participant is currently taking drugs that are solely metabolized by UGT1A9 and UGT2B7. 13. Participant is currently taking strong currently taking strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort). |
Country | Name | City | State |
---|---|---|---|
Czechia | Poliklinika Chocen | Chocen | Pardubice |
Czechia | Neurologie Taláb Radomír Doc. MUDr., CSc | Hradec Králové | |
Czechia | Nemocnice Jihlava | Jihlava | |
Czechia | Fakultní Nemocnice Královské Vinohrady | Praha 10 | |
Czechia | Krajská Zdravotní - Nemocnice Teplice | Teplice | |
Poland | Centrum Medyczne Neuromed - Osrodek Badan Klinicznych | Bydgoszcz | Kujawsko-Pomorskie |
Poland | Neuro-Medic Janusz Zbrojkiewicz | Katowice | Slaskie |
Poland | RESMEDICA Poradnia Neurologiczna | Kielce | Swietokrzyskie |
Poland | SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego w Lodzi | Lódz | |
Poland | Centrum Medyczne Oporów | Lublin | |
Poland | Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej Witoslaw Cieslak | Plewiska | |
Poland | Niepubliczny Zaklad Opieki Zdrowotnej NEURO - KARD | Poznan | Wielkopolskie |
Poland | Centrum Medyczne Neuroprotect | Warszawa | Mazowieckie |
Poland | Centrum Medyczne Pratia - Warszawa | Warszawa | Mazowieckie |
Poland | Wromedica Centrum Zdrowia | Wroclaw | |
Poland | Wromedica Centrum Zdrowia | Wroclaw | Dolnoslaskie |
Poland | Wielospecjalistyczne Centrum Medyczne Ibismed | Zabrze | Slaskie |
Romania | Centrul Medical Clubul Sanatatii | Câmpulung | |
Romania | Spitalul Municipal Caracal | Caracal | |
Romania | Spitalul Clinic Cai Ferate Constanta | Constanta | |
Romania | Spitalul Municipal Sf. Dr. Cosma si Damian Radauti | Radau?i | |
United Kingdom | Barts Health NHS Trust | London | England |
United States | Abington Neurological Associates | Abington | Pennsylvania |
United States | Shepherd Center | Atlanta | Georgia |
United States | American Health Network of Indiana | Avon | Indiana |
United States | University of Alabama at Birmingham School of Medicine | Birmingham | Alabama |
United States | Neurology Clinic - Cordova | Cordova | Tennessee |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | University of Cincinnati (UC) Health | Dayton | Ohio |
United States | Hope Neurology | Knoxville | Tennessee |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Consultants in Neurology - Northbrook | Northbrook | Illinois |
United States | Neurostudies - Port Charlotte | Port Charlotte | Florida |
United States | Raleigh Neurology Associates - Raleigh Location | Raleigh | North Carolina |
United States | Central Texas Neurology Consultants | Round Rock | Texas |
United States | The Multiple Sclerosis Center For Innovations In Care | Saint Louis | Missouri |
United States | Tallahassee Neurological Clinic | Tallahassee | Florida |
United States | Accel Research Sites - Enterprise | Tampa | Florida |
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Jazz Pharmaceuticals |
United States, Czechia, Poland, Romania, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Baseline, Day 84 | ||
Secondary | Change From Baseline in The Multiple Sclerosis Spasticity Scale (MSSS-88) Total Score at Day 85 | Baseline, Day 85 | ||
Secondary | Number of Participants with Treatment-emergent Adverse Events | Baseline through Day 99 | ||
Secondary | Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Test Values at Days 29 and 85 | Baseline, Days 29 and 85 | ||
Secondary | Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Values at Days 15, 29, 57, 85, and 99 | Baseline, Days 15, 29, 57, 85, and 99 | ||
Secondary | Number of Participants with Clinically Significant Changes from Baseline in Physical Examination Values at Day 85 | Baseline, Day 85 | ||
Secondary | Number of Participants with Clinically Significant Changes from Baseline in 12-lead Electrocardiogram (ECG) Values at Days 29 and 85 | Baseline, Days 29 and 85 | ||
Secondary | Mean Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Days 15, 29, 57, and 85 | Days 15, 29, 57, and 85 | ||
Secondary | Plasma Concentrations for Tetrahydrocannabinol (THC), Cannabidiol (CBD), and Relevant Metabolites at Days 1 (Predose), 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 | Days 1, 15, 29, 57, and 85 |
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