Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

Phase 2

Completed

• Conditions: Spasticity in People With Multiple Sclerosis
• Interventions: Drug: VSN16R; Other: Placebo

• Registration Number: NCT02542787
• Lead Sponsor: Canbex Therapeutics Ltd

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	VSN16R	VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days
Placebo	Placebo	Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale	26 days

Secondary Outcome Measures

Name	Time	Method
Modified Ashworth Scale	26 days

Trial Locations

Locations (4)

The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom

The National Hospital for Neurology and Neurosurgery; 🇬🇧 London, United Kingdom

The Royal London Hospital; 🇬🇧 London, United Kingdom

Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust; 🇬🇧 Sheffield, United Kingdom