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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02542787

Enrollment

160

Registered

2015-09-07

Start date

2015-08-31

Completion date

2017-10-31

Last updated

2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity in People With Multiple Sclerosis

Keywords

MS, Spasticity, VSN16R

Brief summary

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

Detailed description

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

Interventions

DRUGVSN16R

Small molecule

OTHERPlacebo

dummy tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Numerical Rating Scale	26 days

Secondary

Measure	Time frame
Modified Ashworth Scale	26 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026