At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 68 enrolled
Drug / intervention
Nabiximols +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients With Multiple Sclerosis
In Brief
A Phase 3 clinical trial evaluating Nabiximols and Placebo for Spasticity in Participants With Multiple Sclerosis. Completed, enrolled 68 participants across 16 sites in 2 countries.
Detailed Summary
This study will be conducted to evaluate the effect of multiple doses of nabiximols as adjunctive therapy compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Modified Ashworth Scale Lower Limb Muscle Tone-6 \[MAS LLMT-6\]) in participants with multiple sclerosis (MS) who have not achieved adequate relief from spasticity with other antispasticity medications.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Poland
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartDec 2020
Primary CompletionMay 2022
Study CompletionMay 2022
TodayJul 2026
First PostedDec 8, 2020
Enrollment StartDec 21, 2020
Primary CompletionMay 4, 2022
Study CompletionMay 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.6 years ago
Interventions
Nabiximolsdrug
oromucosal spray
Placebodrug
oromucosal spray