Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

Spasticity in People With Multiple Sclerosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542787
• Other study ID #: CBX-001
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2015
• Last updated: February 28, 2018
• Start date: August 2015
• Est. completion date: October 2017

Study information

• Verified date: February 2018
• Source: Canbex Therapeutics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis
• Spasticity in People With Multiple Sclerosis

Intervention

Drug:
• VSN16R
Small molecule

Other:
• Placebo
dummy tablet

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Canbex Therapeutics Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale		26 days
Secondary	Modified Ashworth Scale		26 days