A phase II study of VSN16R for Multiple Sclerosis related spasticity
Research type
Research Study
Full title
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.
IRAS ID
166004
Contact name
Harriet Chronis
Contact email
Sponsor organisation
Canbex Therapeutics Ltd
Eudract number
2014-004412-11
Duration of Study in the UK
1 years, 5 months, 17 days
Research summary
Multiple Sclerosis (MS) is a chronic disease of the Central nervous System (CNS) in which the patients immune system damages the nerves in the CNS. In MS, the coating around the nerve fibres (called myelin) is damaged causing a range of symptoms including spasticity, impaired mobility, fatigue, tremor, pain, muscle spasms and bladder dysfunction.
Spasticity is a common symptom in MS and is reported in 90% of patients throughout the course of the illness. Spasticity often co-exisits with painful muscle spasms and both are some of the debilitating aspects of MS with a significant impact on the patients Quality of Life (QoL).
Current oral medication to treat spasticity in MS have modest efficacy and significant side effects. Physical and occupational therapies have show some benefits in treating mild spasticity and are required as an adjunt to pharmacological intervention.
This study is to test a new oral mediation called VSN16R for the first time in patients with MS to evaluate how well the medication works at reducing spasticity. The study will also asses the safety of the medication and look at the levels of the medication in blood.
VSN16R will be administered as a single ascending dose followed by a wash out period then subsequently followed by multiple doses. The effects of VSN16R on reducing spasticity will be determined by changes in baseline values of spasticity rating scales compared to treated rating scales.
The study will recruit 140 adult MS patients, male and female, between the ages of 18 and 70 years of age.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/2156
Date of REC Opinion
16 Jan 2015
REC opinion
Further Information Favourable Opinion