NCT04203498 - Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis | Biotech Hunter

Enrollment

139

Participants

Timeline

Start Date

October 1, 2020

Primary Completion Date

February 10, 2023

Study Completion Date

February 28, 2023

Conditions

Multiple Sclerosis (MS)

Interventions

DRUG

Nabiximols

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.

DRUG

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.

Trial Locations (37)

27607

Raleigh Neurology Associates - Raleigh Location, Raleigh

30309

Shepherd Center, Atlanta

33613

University of South Florida, Tampa

33634

Accel Research Sites - Enterprise, Tampa

33952

Neurostudies - Port Charlotte, Port Charlotte

35233

University of Alabama at Birmingham School of Medicine, Birmingham

37922

Hope Neurology, Knoxville

38018

Neurology Clinic - Cordova, Cordova

45417

University of Cincinnati (UC) Health, Dayton

46123

American Health Network of Indiana, Avon

60062

Consultants in Neurology - Northbrook, Northbrook

63131

The Multiple Sclerosis Center For Innovations In Care, St Louis

70121

Ochsner Medical Center, New Orleans

75390

University of Texas Southwestern Medical Center, Dallas

78681

Central Texas Neurology Consultants, Round Rock

115100

Centrul Medical Clubul Sanatatii, Campulung Muscel

235200

Spitalul Municipal Caracal, Caracal

725400

Spitalul Municipal Sf. Dr. Cosma si Damian Radauti, Radauti

900123

Spitalul Clinic Cai Ferate Constanta, Constanța

565 01

Poliklinika Choceň, Choceň

500 03

Neurologie Taláb Radomír Doc. MUDr., CSc, Hradec Králové

586 01

Nemocnice Jihlava, Jihlava

100 34

Fakultní Nemocnice Královské Vinohrady, Prague

415 29

Krajská Zdravotní - Nemocnice Teplice, Teplice

61-853

Niepubliczny Zakład Opieki Zdrowotnej NEURO - KARD, Poznan

85-163

Centrum Medyczne Neuromed - Ośrodek Badań Klinicznych, Bydgoszcz

51-685

Wromedica Centrum Zdrowia, Wroclaw

01-684

Centrum Medyczne Neuroprotect, Warsaw

01-868

Centrum Medyczne Pratia - Warszawa, Warsaw

40-555

Neuro-Medic Janusz Zbrojkiewicz, Katowice

41-800

Wielospecjalistyczne Centrum Medyczne Ibismed, Zabrze

90-001

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

20-855

Centrum Medyczne Oporów, Lublin

62-064

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

25-726

RESMEDICA Poradnia Neurologiczna, Kielce

E1 1BB

Barts Health NHS Trust, London