Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis

NCT04203498 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: GWSP180232019-002623-14
• Study Type: interventional
• Target: 139
• Locations: 5 countries
• Sites: 37

Brief Summary

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).

Conditions

Multiple Sclerosis (MS)

Keywords

Spasticity

Outcome Measures

Primary Outcomes (1)

• Change in Average Daily Spasm Count From Baseline to Week 12 By 4-Week Period During the 12-Week Randomized Period

  The change in the average daily spasm count was assessed compared to the baseline period.

  Baseline to Week 12

Secondary Outcomes (14)

• Change in Multiple Sclerosis Spasticity Scale (MSSS-88) Total Score

  Week 8 and Week 12

• Number of Patients Reporting Any Treatment-emergent Adverse Events

  From date of first dose of IMP up to 30 days after last dose, up to approximately 16 weeks

• Change From Baseline in Clinical Laboratory Test Values

  Baseline up to Week 12

• Change From Baseline in Erythrocytes

  Baseline up to Week 12

• Change From Baseline in Hemoglobin

  Baseline up to Week 12

Study Arms (2)

Nabiximols

EXPERIMENTAL

Drug: Nabiximols

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nabiximols DRUG

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.

Also known as: GW-1000-02, Sativex

Nabiximols

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Criteria at screening:
• Participant is male or female aged 18 years or above.
• 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.
• 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).
• 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.
• 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.

You may not qualify if:

• Participant has any concomitant disease or disorder that has spasticity-like symptoms or that may influence the participant's level of spasticity.
• Participant has had a relapse of MS within the 60 days prior to screening (Visit 1).
• 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.
• 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.
• Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP.
• 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.
• 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.
• Participant is female and pregnant, lactating, or planning pregnancy during the course of the trial or within 3 months thereafter.
• Participant has received an IMP within the 30 days prior to screening.
• Participant has a history of severe psychiatric disorder that may be exacerbated by the use of a cannabinoid-containing product.
• Participant has any known or suspected history of alcohol or substance abuse (including opiate abuse) or dependence within 1 year prior to screening.
• Participant is currently taking drugs that are solely metabolized by UGT1A9 and UGT2B7.
• Participant is currently taking strong currently taking strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort).

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (37)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, 35233, United States

Location

Neurostudies - Port Charlotte

Port Charlotte, Florida, 33952, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Accel Research Sites - Enterprise

Tampa, Florida, 33634, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Consultants in Neurology - Northbrook

Northbrook, Illinois, 60062, United States

Location

American Health Network of Indiana

Avon, Indiana, 46123, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

The Multiple Sclerosis Center For Innovations In Care

St Louis, Missouri, 63131, United States

Location

Raleigh Neurology Associates - Raleigh Location

Raleigh, North Carolina, 27607, United States

Location

University of Cincinnati (UC) Health

Dayton, Ohio, 45417, United States

Location

Neurology Clinic - Cordova

Cordova, Tennessee, 38018, United States

Location

Hope Neurology

Knoxville, Tennessee, 37922, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

Poliklinika Choceň

Choceň, Pardubice, 565 01, Czechia

Location

Neurologie Taláb Radomír Doc. MUDr., CSc

Hradec Králové, 500 03, Czechia

Location

Nemocnice Jihlava

Jihlava, 586 01, Czechia

Location

Fakultní Nemocnice Královské Vinohrady

Prague, 100 34, Czechia

Location

Krajská Zdravotní - Nemocnice Teplice

Teplice, 415 29, Czechia

Location

Niepubliczny Zakład Opieki Zdrowotnej NEURO - KARD

Poznan, Greater Poland Voivodeship, 61-853, Poland

Location

Centrum Medyczne Neuromed - Ośrodek Badań Klinicznych

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland

Location

Wromedica Centrum Zdrowia

Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

Location

Centrum Medyczne Neuroprotect

Warsaw, Masovian Voivodeship, 01-684, Poland

Location

Centrum Medyczne Pratia - Warszawa

Warsaw, Masovian Voivodeship, 01-868, Poland

Location

Neuro-Medic Janusz Zbrojkiewicz

Katowice, Silesian Voivodeship, 40-555, Poland

Location

Wielospecjalistyczne Centrum Medyczne Ibismed

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego w Łodzi

Lodz, 90-001, Poland

Location

Centrum Medyczne Oporów

Lublin, 20-855, Poland

Location

Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej Witosław Cieślak

Plewiska, 62-064, Poland

Location

Wromedica Centrum Zdrowia

Wroclaw, 51-685, Poland

Location

RESMEDICA Poradnia Neurologiczna

Kielce, Świętokrzyskie Voivodeship, 25-726, Poland

Location

Centrul Medical Clubul Sanatatii

Campulung Muscel, 115100, Romania

Location

Spitalul Municipal Caracal

Caracal, 235200, Romania

Location

Spitalul Clinic Cai Ferate Constanta

Constanța, 900123, Romania

Location

Spitalul Municipal Sf. Dr. Cosma si Damian Radauti

Radauti, 725400, Romania

Location

Barts Health NHS Trust

London, England, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study enrollment was ended early and did not reach the planned number of participants.

Results Point of Contact

• Title: Clinical Trial Disclosure & Transparency
• Organization: Jazz Pharmaceuticals Inc.

ClinicalTrialDisclosure@JazzPharma.com

215-832-3750

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 18, 2019
• Study Start: October 1, 2020
• Primary Completion: February 10, 2023
• Study Completion: February 28, 2023
• Last Updated: May 8, 2024
• Results First Posted: May 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (12); GB (1); CZ (5); US (15); RO (4)