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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.
J Neurol. 2015 Jan; 262(1):27-40.JN

Abstract

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 patients with 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 with time (up to 9 months); at least half of all patients reported a 30 % improvement at all time points. Improvements were observed for all secondary efficacy outcomes, including sleep quality 0-10 NRS scores, neuropathic pain scale scores, subject global impression of change and EQ-5D questionnaire scores. THC/CBD spray was well tolerated for the study duration and patients did not seek to increase their dose with time, with no new safety concerns arising from long-term use. In this previously difficult to manage patient population, THC/CBD spray was beneficial for the majority of patients with PNP associated with diabetes or allodynia.

Authors+Show Affiliations

Pain Management Research, Solihull Hospital, Solihull, UK, wallisb98@gmail.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

25270679

Citation

Hoggart, B, et al. "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." Journal of Neurology, vol. 262, no. 1, 2015, pp. 27-40.
Hoggart B, Ratcliffe S, Ehler E, et al. 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. J Neurol. 2015;262(1):27-40.
Hoggart, B., Ratcliffe, S., Ehler, E., Simpson, K. H., Hovorka, J., Lejčko, J., Taylor, L., Lauder, H., & Serpell, M. (2015). 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. Journal of Neurology, 262(1), 27-40. https://doi.org/10.1007/s00415-014-7502-9
Hoggart B, et al. 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. J Neurol. 2015;262(1):27-40. PubMed PMID: 25270679.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Hoggart,B, AU - Ratcliffe,S, AU - Ehler,E, AU - Simpson,K H, AU - Hovorka,J, AU - Lejčko,J, AU - Taylor,L, AU - Lauder,H, AU - Serpell,M, Y1 - 2014/09/30/ PY - 2014/08/05/received PY - 2014/09/10/accepted PY - 2014/09/09/revised PY - 2014/10/2/entrez PY - 2014/10/2/pubmed PY - 2016/4/5/medline SP - 27 EP - 40 JF - Journal of neurology JO - J. Neurol. VL - 262 IS - 1 N2 - 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 patients with 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 with time (up to 9 months); at least half of all patients reported a 30 % improvement at all time points. Improvements were observed for all secondary efficacy outcomes, including sleep quality 0-10 NRS scores, neuropathic pain scale scores, subject global impression of change and EQ-5D questionnaire scores. THC/CBD spray was well tolerated for the study duration and patients did not seek to increase their dose with time, with no new safety concerns arising from long-term use. In this previously difficult to manage patient population, THC/CBD spray was beneficial for the majority of patients with PNP associated with diabetes or allodynia. SN - 1432-1459 UR - https://www.unboundmedicine.com/medline/citation/25270679/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_ L2 - https://dx.doi.org/10.1007/s00415-014-7502-9 DB - PRIME DP - Unbound Medicine ER -