THCCBD Observational Study Data Evolution of Resistant MS Spasticity and Associated Symptoms.
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 THCCBD 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. 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 THCCBD oromucosal spray. In the Italian cohort, THCCBD 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. While MOVE 2-Italy continues, this interim analysis has enabled us to better define the place in therapy of THCCBD oromucosal spray within the context of daily management of our patients with MS spasticity.