THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms

Area of Science:

• Neurology
• Pharmacology
• Clinical Trials

Background:

• The MObility ImproVEment (MOVE) 2 study collects real-world data on treatment-resistant multiple sclerosis (MS) spasticity.
• Patients are treated with THC:CBD oromucosal spray in routine Italian clinical practice across over 30 MS centers.

Purpose of the Study:

• To perform an interim analysis of the MOVE 2-Italy study.
• To compare collected data with MOVE 2-Germany and a phase III randomized controlled trial (RCT).
• To evaluate the real-world effectiveness and safety of THC:CBD oromucosal spray.

Main Methods:

• Prospective observational study with web-based real-time data collection and patient diaries.
• Interim analysis conducted after exceeding 300 patient recruitment.
• Data collected on patient-reported outcomes and physician-rated scales.

Main Results:

• THC:CBD oromucosal spray was often added to oral baclofen.
• Limited treatment discontinuations observed over 3 months.
• Meaningful improvements in spasticity (0-10 NRS, modified Ashworth scale) at lower doses than RCT.
• Adverse event rate was approximately one-third of that in the RCT.

Conclusions:

• The interim analysis helps define the therapeutic role of THC:CBD oromucosal spray for MS spasticity.
• Real-world data support the efficacy and safety of THC:CBD oromucosal spray.
• The findings contribute to the ongoing management of MS spasticity.