NCT04657666Phase 3Completed

Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-05-04Actual

Enrollment · participants68Actual

Source updated2023-07-20Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Spasticity in Participants With Multiple Sclerosis

Treatments or interventions studied

NabiximolsDrugAlso known as GW-1000-02, Sativex
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline in Lower Limb Muscle Tone-6 (LLMT-6); description: LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS) transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-6 score is being reported. Negative values indicate an improvement in muscle tone.; timeFrame: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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