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THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms.
Eur Neurol. 2016; 75 Suppl 1:4-8.EN

Abstract

BACKGROUND

The prospective observational MObility ImproVEment (MOVE) 2 study is collecting real-life clinical outcomes data on patients with treatment-resistant multiple sclerosis (MS) spasticity treated with THC:CBD oromucosal spray in routine clinical practice. The MOVE 2 study has been ongoing in Italy, involving more than 30 MS centres across the country, since 2013.

METHODS

Web-based real-time data collection techniques are combined with traditional patients' diaries to capture a wide spectrum of outcomes associated with this innovative cannabis-based medication. After surpassing the recruitment threshold of 300 patients, an interim analysis was performed to determine whether the data collected to date align with those from MOVE 2-Germany and the largest phase III randomized controlled trial (RCT) of THC:CBD oromucosal spray.

RESULTS

In the Italian cohort, THC:CBD oromucosal spray was added mainly to oral baclofen. Similar to MOVE 2-Germany, during 3 months' observation, treatment discontinuations were limited and patients recorded meaningful improvements on the patient-based 0-10 numerical rating scale and physician-rated modified Ashworth scale at mean daily doses that were about one-third lower than those used in the RCT. Also, similar to MOVE 2-Germany, the proportion of patients reporting adverse events was about one-third of the rate recorded in the RCT.

CONCLUSIONS

While MOVE 2-Italy continues, this interim analysis has enabled us to better define the place in therapy of THC:CBD oromucosal spray within the context of daily management of our patients with MS spasticity.

Authors+Show Affiliations

Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy.

Pub Type(s)

Journal Article
Observational Study

Language

eng

PubMed ID

26901343

Citation

Trojano, Maria. "THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms." European Neurology, vol. 75 Suppl 1, 2016, pp. 4-8.
Trojano M. THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms. Eur Neurol. 2016;75 Suppl 1:4-8.
Trojano, M. (2016). THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms. European Neurology, 75 Suppl 1, 4-8. https://doi.org/10.1159/000444235
Trojano M. THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms. Eur Neurol. 2016;75 Suppl 1:4-8. PubMed PMID: 26901343.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms. A1 - Trojano,Maria, Y1 - 2016/02/23/ PY - 2016/2/23/entrez PY - 2016/2/24/pubmed PY - 2016/10/7/medline SP - 4 EP - 8 JF - European neurology JO - Eur. Neurol. VL - 75 Suppl 1 N2 - BACKGROUND: The prospective observational MObility ImproVEment (MOVE) 2 study is collecting real-life clinical outcomes data on patients with treatment-resistant multiple sclerosis (MS) spasticity treated with THC:CBD oromucosal spray in routine clinical practice. The MOVE 2 study has been ongoing in Italy, involving more than 30 MS centres across the country, since 2013. METHODS: Web-based real-time data collection techniques are combined with traditional patients' diaries to capture a wide spectrum of outcomes associated with this innovative cannabis-based medication. After surpassing the recruitment threshold of 300 patients, an interim analysis was performed to determine whether the data collected to date align with those from MOVE 2-Germany and the largest phase III randomized controlled trial (RCT) of THC:CBD oromucosal spray. RESULTS: In the Italian cohort, THC:CBD oromucosal spray was added mainly to oral baclofen. Similar to MOVE 2-Germany, during 3 months' observation, treatment discontinuations were limited and patients recorded meaningful improvements on the patient-based 0-10 numerical rating scale and physician-rated modified Ashworth scale at mean daily doses that were about one-third lower than those used in the RCT. Also, similar to MOVE 2-Germany, the proportion of patients reporting adverse events was about one-third of the rate recorded in the RCT. CONCLUSIONS: While MOVE 2-Italy continues, this interim analysis has enabled us to better define the place in therapy of THC:CBD oromucosal spray within the context of daily management of our patients with MS spasticity. SN - 1421-9913 UR - https://www.unboundmedicine.com/medline/citation/26901343/THC:CBD_Observational_Study_Data:_Evolution_of_Resistant_MS_Spasticity_and_Associated_Symptoms_ L2 - https://www.karger.com?DOI=10.1159/000444235 DB - PRIME DP - Unbound Medicine ER -