A multicentre, open-label, follow-on study to assess the long-term maintenance of effect, tolerance and safety of THC/CBD oromucosal spray in the management of neuropathic pain

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216275%3A25520%2F15%3A39898742" target="_blank" >RIV/00216275:25520/15:39898742 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.1007/s00415-014-7502-9" target="_blank" >http://dx.doi.org/10.1007/s00415-014-7502-9</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s00415-014-7502-9" target="_blank" >10.1007/s00415-014-7502-9</a>

Result language

angličtina

Original language name

A multicentre, open-label, follow-on study to assess the long-term maintenance of effect, tolerance and safety of THC/CBD oromucosal spray in the management of neuropathic pain

Original language description

Peripheral neuropathic pain (PNP) poses a significant clinical challenge. The long-term efficacy of delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was investigated in this 38-week open-label extension study. In total, 380 patientswith PNP associated with diabetes or allodynia entered this study from two parent randomised, controlled trials. Patients received THC/CBD spray for a further 38 weeks in addition to their current analgesic therapy. Neuropathic pain severity was the primary efficacy measure using a pain 0-10 numerical rating scale (NRS). Additional efficacy, safety and tolerability outcomes were also investigated. In total, 234 patients completed the study (62 %). The pain NRS showed a decrease in score over time in patients from a mean of 6.9 points (baseline in the parent studies) to a mean of 4.2 points (end of open-label follow-up). The proportion of patients who reported at least a clinically relevant 30 % improvement in pain continued to increase

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FH - Neurology, neuro-surgery, nuero-sciences

OECD FORD branch

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Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2015

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of Neurology

ISSN

0340-5354

e-ISSN

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Volume of the periodical

262

Issue of the periodical within the volume

1

Country of publishing house

DE - GERMANY

Number of pages

14

Pages from-to

27-40

UT code for WoS article

000348216000004

EID of the result in the Scopus database

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