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

Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.

Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.

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