A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders
Status:
Not yet recruiting
Trial end date:
2026-09-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to evaluate the safety and efficacy of nabiximols, a
cannabinoid spray, for the treatment of moderate to severe spasticity in adult patients with
AQP4-IgG positive and antibody-negative NMOSD. The main question it aims to answer is whether
treatment with nabiximols improves patient-reported spasticity ratings compared to treatment
with a placebo. This trial will also answer whether nabiximols impact pain, spasm frequency,
mood, walking ability, and sleep. Participants will be mailed the treatments and placebo
treatments, and will be asked to complete study visits and questionnaires remotely. There is
also an optional sub-study that involves in-person visits with ultrasound imaging and
in-person neurologic exams.