Nabiximols

Generic Name
Nabiximols
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C42H60O4
CAS Number
56575-23-6
Unique Ingredient Identifier
K4H93P747O
Background

Nabiximols (tradename Sativex®) is a whole plant extract from the Cannabis species Cannabis sativa L. that has been purified into the active components CBD (cannabidiol) and THC (delta-9-tetrahydrocannabinol). For trademark purposes, purified CBD is branded as Nabidiolex®, while THC is purified as the product Tetrabinex®. Sativex® is available in a 1:1 formu...

Indication

In Canada, Sativex has received a Notice of Compliance (NOC) for use as an as adjunctive treatment for symptomatic relief of spasticity in patients with multiple sclerosis (MS) who have not responded adequately to other therapy and who demonstrate meaningful improvement during an initial trial of therapy.
...

Associated Conditions
-
Associated Therapies
-

A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2023-08-03
Last Posted Date
2024-11-25
Lead Sponsor
Michael, Levy M.D.,Ph.D.
Target Recruit Count
44
Registration Number
NCT05974293
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

First Posted Date
2022-11-29
Last Posted Date
2024-12-13
Lead Sponsor
University of Birmingham
Target Recruit Count
234
Registration Number
NCT05629702
Locations
🇬🇧

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom

🇬🇧

Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom

🇬🇧

Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust, Maidstone, United Kingdom

and more 18 locations

Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis

First Posted Date
2021-07-30
Last Posted Date
2024-12-11
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
56
Registration Number
NCT04984278
Locations
🇨🇿

NeuropsychiatrieHK, Hradec Králové, Czechia

🇪🇸

Hospital Universitario Ramón y Cajal, Madrid, Spain

🇪🇸

Hospital Vithas Nisa Sevilla, Sevilla, Spain

and more 26 locations

Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis

First Posted Date
2020-12-08
Last Posted Date
2023-07-20
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
68
Registration Number
NCT04657666
Locations
🇵🇱

Clinical Trial Site 2, Poznan, Wielkopolskie, Poland

🇵🇱

Clinical Trial Site, Zabrze, Poland

🇵🇱

Clinical Trial Site 3, Katowice, Slaskie, Poland

and more 1 locations

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

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2019-12-18
Last Posted Date
2024-05-08
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
139
Registration Number
NCT04203498
Locations
🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

🇵🇱

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

🇺🇸

Neurostudies - Port Charlotte, Port Charlotte, Florida, United States

and more 33 locations

CANNAbinoids in the Treatment of TICS (CANNA-TICS)

First Posted Date
2017-03-22
Last Posted Date
2020-12-10
Lead Sponsor
Hannover Medical School
Target Recruit Count
98
Registration Number
NCT03087201
Locations
🇩🇪

University of Freiburg, Psychiatry and Psychotherapy, Freiburg, Germany

🇩🇪

Uniklinik RWTH Aachen, Psychiatry and Psychotherapy, Aachen, Germany

🇩🇪

University Hospital Cologne, Psychiatry and Psychotherapy, Cologne, Germany

and more 3 locations

A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-08-29
Last Posted Date
2023-04-12
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
406
Registration Number
NCT01424566

Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-05-27
Last Posted Date
2023-04-12
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
399
Registration Number
NCT01361607

Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-04-18
Last Posted Date
2023-04-12
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
660
Registration Number
NCT01337089
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