Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis
A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects With Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Vsn-16r
Placebo
- Placebo
What it measured
Main measures
Numerical Rating Scale
26 days
Efficacy analysis by:
Other measures (2)
Modified Ashworth Scale
26 days
SpasticityModified Ashworth Scale
Spasticity
Who could take part
MS (type not specified) · 18 to 70
Show the full criteria
Inclusion criteria
* Have a confirmed diagnosis of MS * Have an Expanded Disability Status Scale (EDSS) ≤ than 6.5 at screening. * Spasticity due to MS of at least 3 months duration with minimum mean score of >/=2 mASH
Exclusion criteria
* Acute MS relapse requiring treatment with steroids within 30 days of screening. * Initiation or discontinuation of MS disease modifying treatment (DMT) within 30 days of screening. * Receiving medications that would potentially interfere with the actions of the study medication or outcome variables * Significant renal and hepatic abnormalities * Previous history of other significant medical disorders
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.
Papers
Loading reviews and guidelines…
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No results found
History
Started
Aug 2015
Main results due
Oct 2017
Finished
Oct 2017