SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTI
SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICS
What it found
We found no results in the registry or in papers.
What it measured
Main measures
Responder selection for the primary endpoint (30% NRS spasticity improvement) will be based on the comparison at Visit 4 (mean of NRS at the day of Visit 4 and the 2 previous days) and Visit 7 (mean of NRS at the day of visit 7 and the 6 previous days).
Spasticity
Other measures (1)
The secondary efficacy variables are measurements of spasticity and associated symptoms during the randomized treatment period (Phase B):
Spasticity
Who could take part
MS (type not specified)
Show the full criteria
Inclusion criteria
Inclusion: 1.Male or female patients of at least 18 years of age. Exclusion: 1.Contraindication to treatment with Sativex (according to the SPC).
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of this study is to evaluate the efficacy of Sativex (tetrahydrocannabinol [THC]:cannabidiol [CBD] oromucosal spray) as add-on therapy compared to further optimized standard antispastic therapy with oral baclofen and/or tizanidine and/or dantrolene (mono- or combination therapy) in patients with moderate to severe spasticity due to MS who have not gained adequate relief through 2 optimized standard antispastic drugs.
Papers
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History
Started
Dec 2015