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Serpell, M.G.; Ratcliffe, S.H.R.; Hovorka, J.; Schofield, M.
Languages: English
Types: Other
Subjects: R1
No abstract available.
  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

    • 1Gartnavel General, Univ. of Glasgow, UK; 2MAC UK Neuroscience Ltd., Manchester, UK; 3Neurologicke oddeleni, Prague, CZ; 4West Suffolk Hospital, Bury St Edmunds, UK.
    • • Formulated into a spray for sublingual/oromucosal administration; • Highly standardised formulation, each 100µl spray of Sativex® contains 2.7 mg Δ9- tetrahydrocannabinol (THC), 2.5mg cannabidiol (CBD), and small amounts of other cannabinoids; • Approved in Canada for relief of central neuropathic pain in MS and cancer pain.
    • Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 42 days 70 days Peripheral Neuropathic Pain (PNP): • Management of PNP is a significant challenge; • Currently the most difficult pain to treat; • Current therapies have a limited effect on PNP and can cause side effects; • Recent research indicates that cannabinoids have therapeutic potential1,2; • This study aimed to evaluate the long term efficacy of Sativex in relieving chronic PNP and to assess the safety of Sativex in study patients with PNP associated with allodynia.
    • • A 15-week (one-week baseline and 14-week treatment period), multicentre, double blind, randomised, placebo controlled parallel group study; • Patients randomised to either Sativex or placebo and self-titrated study medication based on efficacy and tolerability, up to a maximum of 24 sprays/day; • Patients had chronic (≥six months) PNP associated with allodynia, and secondary to post-herpetic neuralgia, peripheral neuropathy or focal nerve lesion or Complex Regional Pain Syndrome type 2.
    • - Change from baseline in 0-10 numerical rating scale (0-10 NRS) pain severity scores - Responder analysis (≥30% decrease in 0-10 NRS pain severity score from baseline) - Brief pain inventory (BPI) - Rescue analgesic use - Neuropathic pain scale (NPS) - Sleep quality 0-10 NRS - Subject global impression of change (SGIC) - Quality of life questionnaire (EQ-5D) 7 days 14 days 28 days Withdrawn (n=49): AE (24), withdrew consent (7), lost to fol ow up (7), lack of efficacy (11), other (0) Screened (n=303) 7-day baseline period 7-day baRsaelnindeopmeriisoded (n=246) Sativex (n=128) Placebo (n=118) 98 days treatment Completed (n=79) Completed (n=94) Withdrawn (n=24): The two treatment groups were closely matched for all demographic and baseline characteristics.
    • • The pain responder analysis was statistically significant in favour of Sativex with an odds ratio of 1.97.
    • • For 30% responders, the proportion of responders was observed to increase much more quickly in relation to the dose of Sativex compared with placebo (illustrated below). Explain better?? Visit 7 • On average, the Sativex group used fewer doses of rescue analgesic than the placebo group.
  • No related research data.
  • No similar publications.

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