The effect of cannabis-based medicine on neuropathic pain and spasticity in patients with multiple sclerosis and spinal cord injury: Study protocol of a national multicenter double-blinded, placebo-controlled trial

Julie Schjødtz Hansen*, Rikke Middelhede Hansen, Thor Petersen, Stefan Gustavsen, Annette Bang Oturai, Finn Sellebjerg, Eva Aggerholm Sædder, Helge Kasch, Peter Vestergaard Rasmussen, Nanna Brix Finnerup, Kristina Bacher Svendsen

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Abstrakt

Disease or acquired damage to the central nervous system frequently causes disabling spasticity and central neuropathic pain (NP), both of which are frequent in multiple sclerosis (MS) and spinal cord injury (SCI). Patients with MS and SCI often request treatment with cannabis-based medicine (CBM). However, knowledge about effects, side effects, choice of active cannabinoids (∆9-tetrahydrocannabinol (THC), cannabidiol (CBD) alone or in combination), and doses of CBM remains limited. Using a double-blind, parallel design in a national multicenter cohort, this study examines the effect of CBM on spasticity and NP. Patients are randomized to treatment with capsules containing either THC, CBD, THC and CBD, or placebo. Primary endpoints are patient-reported pain and spasticity on a numerical rating scale. Other endpoints include quality of life and sleep, depression and anxiety, and relief of pain and spasticity. Side-effects of CBM are described. In a sub-study, the pharmacodynamics (PD) and pharmacokinetics (PK) of oral capsule CBM are examined. We expect that the study will contribute to the literature by providing information on the effects and side-effects of CBD, THC, and the combination of the two for central neuropathic pain and spasticity. Furthermore, we will describe the PD/PK of THC and CBD in a patient population.

OriginalsprogEngelsk
Artikelnummer1212
TidsskriftBrain Sciences
Vol/bind11
Udgave nummer9
Antal sider13
ISSN2076-3425
DOI
StatusUdgivet - 14. sep. 2021

Bibliografisk note

Funding Information:
This research is funded by The Danish Ministry of Health, The Danish Multiple Sclerosis Society, Bdr. Hartmann Foundation, Karen A Tolstrup Foundation, ?Direkt?r Ejnar Jonasson kaldet Johnsen og Hustru?s Mindelegat?, Fonden for neurologisk forskning.

Funding Information:
Conflicts of Interest: E.A.S. and H.K. declare no competing interest. S.G. has received support for congress participation from Merck. K.S. received travel grants from TEVA, Biogen, Merck, and Novartis. J.S.H has received travel grants from Almirall and Roche. N.B.F has received consultancy fees from Merck, Almirall, NeuroPN, Vertex, and Novartis Pharma, and has undertaken consultancy work for Aarhus University with remunerated work for Biogen, Merz, and Confo Therapeutics. She has received grants from IMI2PainCare, an EU IMI 2 (Innovative medicines initiative) public-private consortium and the companies involved are: Grunenthal, Bayer, Eli Lilly, Esteve, and Teva. P.V.R. has received speaker honoraria from Biogen, Roche, Merck, Alexion, and Novartis; support for congress participation from Merck, Roche, and Sanofi; fees for serving on advisory boards from Bristol-Myers-Squibb, Merck, Roche, Novartis, Biogen, Sanofi, and Alexion. F.S. has served on scientific advisory boards for, served as consultant for, received support for congress participation, or received speaker honoraria from Alexion, Biogen, Bristol Myers Squibb, H. Lundbeck A/S, Merck, Novartis, Roche, and Sanofi Genzyme. His laboratory has received research support from Biogen, Merck, Novartis, Roche, and Sanofi Genzyme. R.M.H. has received support for congress participation from Merck and Ipsen. A.B.O. has served on scientific advisory boards for Biogen Idec, Novartis, and Sanofi Genzyme; has received research support from Novartis; has received speaker honoraria from Biogen, Novartis, and TEVA; and has received support for congress participation from, Merck, TEVA, Biogen, Roche, Novartis, and Sanofi Genzyme. T.S. has received research support to the MS clinic at Aarhus University Hospital from Merck, Alexion, Roche, Biogen, Novartis, and Sanofi.

Funding Information:
Funding: This research is funded by The Danish Ministry of Health, The Danish Multiple Sclerosis Society, Bdr. Hartmann Foundation, Karen A Tolstrup Foundation, ”Direktør Ejnar Jonasson kaldet Johnsen og Hustru’s Mindelegat”, Fonden for neurologisk forskning.

Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.

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